4913 Federal Register / Vol. 79, No.

20/ Thursday, January 30, 2014/ Notices

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA2004N0451]
Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
034
AGENCY: Food and Drug Administration,
HHS.
ACTION: Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
publication containing modifications
the Agency is making to the list of
standards FDA recognizes for use in
premarket reviews (FDA recognized
consensus standards). This publication,
entitled Modifications to the List of
Recognized Standards, Recognition List
Number: 034 (Recognition List
Number: 034), will assist manufacturers
who elect to declare conformity with
consensus standards to meet certain
requirements for medical devices.
DATES: Submit written or electronic
comments concerning this document at
any time. See section VII for the
effective date of the recognition of
standards announced in this document.
ADDRESSES: Submit written requests for
single copies of Modifications to the
List of Recognized Standards,
Recognition List Number: 034 to the
Division of Small Manufacturers,
International and Consumer Assistance,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Silver Spring, MD 20993. Send two self-
addressed adhesive labels to assist that
office in processing your requests, or fax
your request to 3018478149. Submit
written comments concerning this
document, or recommendations for
additional standards for recognition, to
the contact person (see FOR FURTHER
INFORMATION CONTACT). Submit
electronic comments by email:
[email protected]. This document
may also be accessed on FDAs Internet
site at http://www.fda.gov/Medical
Devices/DeviceRegulationandGuidance/
Standards/ucm123792.htm. See section
VI for electronic access to the searchable
database for the current list of FDA
recognized consensus standards,
including Recognition List Number: 034
modifications and other standards
related information.
FOR FURTHER INFORMATION CONTACT:
Scott A. Colburn, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3632, Silver Spring,
MD 20993, 3017966287.
I. Background
Section 204 of the Food and Drug
Administration Modernization Act of
1997 (FDAMA) (Pub. L. 105115)
amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360d). Amended
section 514 allows FDA to recognize
consensus standards developed by
international and national organizations
for use in satisfying portions of device
premarket review submissions or other
requirements.
In a notice published in the Federal
Register of February 25, 1998 (63 FR
9561), FDA announced the availability
of a guidance entitled Recognition and
Use of Consensus Standards. The
notice described how FDA would
implement its standard recognition
program and provided the initial list of
recognized standards.
Modifications to the initial list of
recognized standards, as published in
the Federal Register, can be accessed at
http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123792.htm.
These notices describe the addition,
withdrawal, and revision of certain
standards recognized by FDA. The
Agency maintains hypertext markup
language (HTML) and portable
document format (PDF) versions of the
list of FDA Recognized Consensus
Standards. Both versions are publicly
accessible at the Agencys Internet site.
See section VI for electronic access
information. Interested persons should
review the supplementary information
sheet for the standard to understand
fully the extent to which FDA
recognizes the standard.
II. Modifications to the List of
Recognized Standards, Recognition List
Number: 034
FDA is announcing the addition,
withdrawal, correction, and revision of
certain consensus standards the Agency
will recognize for use in premarket
submissions and other requirements for
devices. FDA will incorporate these
modifications in the list of FDA
Recognized Consensus Standards in the
Agencys searchable database. FDA will
use the term Recognition List Number:
034 to identify these current
modifications.
In table 1 of this document, FDA
describes the following modifications:
(1) The withdrawal of standards and
their replacement by others, if
applicable; (2) the correction of errors
made by FDA in listing previously
recognized standards; and (3) the
changes to the supplementary
information sheets of recognized
standards that describe revisions to the
applicability of the standards.
In section III of this document, FDA
lists modifications the Agency is making
that involve the initial addition of
standards not previously recognized by
FDA.
TABLE 1MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS
Old
recognition
No.
Replacement
recognition
No.
Title of standard
1
Change
A. Anesthesia
115 ................... ........................... ISO 53614:1987, Tracheal tubesPart 4: Cole type ........................ Withdrawn. See 193.
118 ................... 194 ................. ISO 8359 Second edition 19961215, Oxygen concentrators for
medical useSafety requirements [Including: AMENDMENT 1
20120701].
Withdrawn and replaced with
newer version including amend-
ment.
136 ................... 195 ................. ISO 53663 Second edition 20010815, Anaesthetic and res-
piratory equipmentTracheostomy tubesPart 3: Pediatric tra-
cheostomy tubes [Including: TECHNICAL CORRIGENDUM 1 Pub-
lished 20030115].
Withdrawn and replaced with
newer version including tech-
nical corrigendum.
144 ................... ........................... ISO 53661 Fourth edition 20001215, Anaesthetic and respiratory
equipmentTracheostomy tubesPart 1: Tubes and connectors
for use in adults.
Extent of recognition.
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4914 Federal Register / Vol. 79, No. 20/ Thursday, January 30, 2014/ Notices
TABLE 1MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDSContinued
Old
recognition
No.
Replacement
recognition
No.
Title of standard
1
Change
146 ................... ........................... ISO 5367 Fourth edition 20000601 Breathing tubes intended for
use with anaesthetic apparatus and ventilators.
Extent of recognition.
147 ................... ........................... AS 42591995 Ancillary devices for expired air resuscitation .......... Extent of recognition.
156 ................... 197 ................. CGA V7.1:2011 Standard Method of Determining Cylinder Valve
Outlet Connections for Medical Gases.
Withdrawn and replaced with
newer version.
157 ................... ........................... ASTM F110190 (Reapproved 2003)
1
, Standard Specification for
Ventilators Intended for Use During Anesthesia.
Extent of recognition.
158 ................... ........................... ASTM G17503 (Reapproved 2011), Standard Test Method for Eval-
uating the Ignition Sensitivity and Fault Tolerance of Oxygen Reg-
ulators Used for Medical and Emergency Applications.
Extent of recognition.
165 ................... ........................... ISO 21647:2004 Medical electrical equipmentParticular require-
ments for the basic safety and essential performance of respiratory
gas monitors.
Withdrawn. See 196.
169 ................... ........................... ASTM F146493 (Reapproved 2005) Standard Specification for Oxy-
gen Concentrators for Domiciliary Use.
Extent of recognition.
170 ................... ........................... ASTM F124691 (Reapproved 2005) Standard Specification for
Electrically Powered Home Care Ventilators, Part 1Positive-
Pressure Ventilators and Ventilator Circuits.
Extent of recognition.
178 ................... ........................... ASME PVHO12007 Safety Standard for Pressure Vessels for
Human Occupancy.
Extent of recognition.
181 ................... ........................... CGA V5:2008 (Reaffirmed 2013), Diameter-Index Safety System
(Noninterchangeable Low Pressure Connections for Medical Gas
Applications).
Reaffirmation.
183 ................... ........................... ISO 21647:2004 TECHNICAL CORRIGENDUM 1, Medical elec-
trical equipmentParticular requirements for the basic safety and
essential performance of respiratory gas monitors.
Withdrawn. See 196.
184 ................... ........................... ISO 53663:2001 Anaesthetic and Respiratory EquipmentTra-
cheostomy TubesPart 3: Pediatric Tracheostomy Tubes TECH-
NICAL CORRIGENDUM 1.
Withdrawn. See 195.
186 ................... ........................... ISO 8185 Third edition 20070701 Corrected versions 20080615
Respiratory tract humidifiers for medical useParticular require-
ments for respiratory humidification systems.
Extent of recognition.
188 ................... 198 ................. ISO 80601212 First edition 20110415 Medical electrical equip-
mentPart 212: Particular requirements for the safety of lung
ventilatorsCritical care ventilators [Including: TECHNICAL COR-
RIGENDUM 1 Published 20111015].
Withdrawn and replaced with
newer version including tech-
nical corrigendum.
189 ................... ........................... ISO 80601212 TECHNICAL CORRIGENDUM 1 Medical electrical
equipment Part 212: Particular requirements for basic safety and
essential performance of critical care ventilators.
Withdrawn. See 198.
190 ................... ........................... ISO 8359 Second edition 19961215 AMENDMENT 1 20120701
Oxygen concentrators for medical useSafety requirements.
Withdrawn. See 194.
192 ................... ........................... ISO 175102 Second Edition 20071001, Sleep apnoea breathing
therapyPart 2: Masks and application accessories.
Extent of recognition.
193 ................... ISO 5361 .......... Second edition 20121001 Anaesthetic and respiratory equip-
mentTracheal tubes and connectors.
Extent of recognition.
B. Biocompatibility
2123 ................. 2204 ............... ASTM F72013 Standard Practice for Testing Guinea Pigs for Con-
tact Allergens: Guinea Pig Maximization Test.
Withdrawn and replaced with
newer version.
2182 ................. 2205 ............... ISO 14155 Second edition 20110201 Clinical investigations of
medical devices for human subjectsGood clinical practices [In-
cluding TECHNICAL CORRIGENDUM 1:2011].
Withdrawn and replaced with
newer version including tech-
nical corrigendum.
2183 ................. ........................... ISO 14155:2011 and TECHNICAL CORRIGENDUM 1 Published
20110715 Clinical investigation of medical devices for human
subjectsGood clinical practice.
Withdrawn. See 2205.
293 ................... ........................... ASTM F76304 (Reapproved 2010), Standard Practice for Short-
Term Screening of Implant Materials.
Extent of recognition.
294 ................... ........................... ASTM F98104 (Reapproved 2010) Standard Practice for Assess-
ment of Compatibility of Biomaterials for Surgical Implants with Re-
spect to Effect of Materials on Muscle and Bone.
Extent of recognition.
2114 ................. ........................... ASTM F187705 (Reapproved 2010) Standard Practice for Charac-
terization of Particles.
Extent of recognition.
2118 ................. ........................... ANSI/AAMI/ISO 1099311:2006/(R) 2010 Biological evaluation of
medical devicesPart 11: Tests for systemic toxicity.
Extent of recognition.
2120 ................. ........................... ANSI/AAMI/ISO 109936:2007/(R) 2010 Biological evaluation of
medical devicesPart 06: Tests for local effects after implantation.
Extent of recognition.
2126 ................. ........................... ASTM F74806 (Reapproved 2010) Standard Practice for Selecting
Generic Biological Test Methods for Materials and Devices.
Extent of recognition.
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4915 Federal Register / Vol. 79, No. 20/ Thursday, January 30, 2014/ Notices
TABLE 1MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDSContinued
Old
recognition
No.
Replacement
recognition
No.
Title of standard
1
Change
2133 ................. ........................... ASTM F140897 (Reapproved 2008) Standard Practice for Subcuta-
neous Screening Test for Implant Materials.
Extent of recognition.
2134 ................. ........................... ASTM F206500 (Reapproved 2010) Standard Practice for Testing
for Alternative Pathway Complement Activation in Serum by Solid
Materials.
Extent of recognition.
2136 ................. ........................... ASTM E126288 (Reapproved 2008) Standard Guide for Perform-
ance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine
Phosphoribosyl Transferase Gene Mutation Assay.
Extent of recognition.
2137 ................. ........................... ASTM E126397 (Reapproved 2008) Standard Guide for Conduct of
Micronucleus Assays in Mammalian Bone Marrow Erythrocytes.
Withdrawn.
2138 ................. ........................... ASTM E128097 (Reapproved 2008) Standard Guide for Performing
the Mouse Lymphoma Assay for Mammalian Cell Mutagenicity.
Withdrawn.
2139 ................. ........................... ASTM E139791 (Reapproved 2008) Standard Practice for the In
Vitro Rat Hepatocyte DNA Repair Assay.
Withdrawn.
2140 ................. ........................... ASTM E139891 (Reapproved 2008) Standard Practice for the In
Vivo Rat Hepatocyte DNA Repair Assay.
Withdrawn.
2141 ................. ........................... ASTM F198499 (Reapproved 2008) Standard Practice for Testing
for Whole Complement Activation in Serum by Solid Materials.
Extent of recognition.
2142 ................. ........................... ASTM F198399 (Reapproved 2008) Standard Practice for Assess-
ment of Compatibility of Absorbable/Resorbable Biomaterials for
Implant Application.
Extent of recognition.
2143 ................. ........................... ASTM F190498 (Reapproved 2008) Standard Practice for Testing
the Biological Responses to Particles in vivo.
Extent of recognition.
2144 ................. ........................... ASTMF61903 (Reapproved 2008) Standard Practice for Extraction
of Medical Plastics.
Extent of recognition.
2145 ................. ........................... ASTM F143903 (Reapproved 2008) Standard Guide for Perform-
ance of Lifetime Bioassay for the Tumorigenic Potential of Implant
Materials.
Extent of recognition.
2153 ................. ........................... ANSI/AAMI/ISO 109935:2009, Biological evaluation of medical de-
vicesPart 5: Tests for In Vitro cytotoxicity.
Extent of recognition.
2154 ................. ........................... ASTM F75608 Standard Practice for Assessment of Hemolytic
Properties of Materials.
Extent of recognition.
2155 ................. ........................... ASTM F214701 (Reapproved 2010) Standard Practice for Guinea
Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens.
Extent of recognition.
2156 ................. ........................... ANSI/AAMI/ISO 109931:2009 Biological evaluation of medical de-
vicesPart 1: Evaluation and testing within a risk management.
Extent of recognition.
2162 ................. ........................... ASTM F190310 Standard Practice for Testing for Biological Re-
sponses to Particles in vitro.
Extent of recognition.
2163 ................. ........................... ANSI/AAMI/ISO 109939:2009 Biological evaluation of medical de-
vicesPart 9: Framework for identification and quantification of
potential degradation products.
Extent of recognition.
2165 ................. ........................... ANSI/AAMI/ISO 1099314:2001/(R) 2011 Biological evaluation of
medical devicesPart 14: Identification and quantification of deg-
radation products from ceramics.
Extent of recognition.
2167 ................. ........................... ISO/TS 1099319 First edition 20060601 Biological evaluation of
medical devicesPart 19: Physico-chemical, morphological, and
topographical characterization of materials.
Extent of recognition.
2168 ................. ........................... ISO 109939 Second edition 20091215 Biological evaluation of
medical devicesPart 9: Framework for identification and quan-
tification of potential degradation products.
Extent of recognition.
2169 ................. ........................... ISO 1099313 Second edition 20100615 Biological evaluation of
medical devicesPart 13: Identification and quantification of deg-
radation products from polymeric medical devices.
Extent of recognition.
2170 ................. ........................... ISO 1099314 First edition 20011115 Biological evaluation of
medical devicesPart 14: Identification and quantification of deg-
radation products from ceramics.
Extent of recognition.
2171 ................. ........................... ISO 1099316 Second edition 20100215 Biological evaluation of
medical devicesPart 16: Toxicokinetic study design for degrada-
tion products and leachables.
Extent of recognition.
2172 ................. ........................... ANSI/AAMI/ISO TIR 1099319:2006 Biological evaluation of med-
ical devicesPart 19: Physicochemical, morphological, and topo-
graphical characterization of materials.
Extent of recognition.
2173 ................. ........................... ANSI/AAMI/ISO 1099310:2010 Biological evaluation of medical
devicesPart 10: Tests for irritation and skin sensitization.
Extent of recognition.
2174 ................. ........................... ISO 1099310:2010 Biological evaluation of medical devicesPart
10: Tests for irritation and skin sensitization.
Extent of recognition.
2175 ................. ........................... ISO 109933 Second edition 20031015 Biological evaluation of
medical devices Part 3: Tests for genotoxicity, carcinogenicity and
reproductive toxicity.
Extent of recognition.
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4916 Federal Register / Vol. 79, No. 20/ Thursday, January 30, 2014/ Notices
TABLE 1MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDSContinued
Old
recognition
No.
Replacement
recognition
No.
Title of standard
1
Change
2176 ................. ........................... ISO 1099311 Second edition 20060815 Biological evaluation of
medical devicesPart 11: Tests for systemic toxicity.
Extent of recognition.
2177 ................. ........................... ISO 1099306 Second edition 20070415 Biological evaluation of
medical devicesPart 6: Tests for local effects after implantation.
Extent of recognition.
2179 ................. ........................... ISO 109931 Fourth edition 20091015 Biological evaluation of
medical devicesPart 1: Evaluation and testing within a risk man-
agement process.
Extent of recognition.
2181 ................. ........................... ANSI/AAMI/ISO 14155:2011, Clinical investigation of medical devices
for human subjectsGood clinical practice.
Extent of recognition.
2189 ................. ........................... ASTM F89511, Standard Test Method for Agar Diffusion Cell Cul-
ture Screening for Cytotoxicity.
Extent of recognition.
2190 ................. ........................... ANSI/AAMI/ISO 1099313:2010, Biological evaluation of medical de-
vicesPart 13: Identification and quantification of degradation
products from polymeric medical devices.
Extent of recognition.
2191 ................. ........................... ISO 1099312 Fourth edition 20120701, Biological evaluation of
medical devicesPart 12: Sample preparation and reference ma-
terials.
Extent of recognition.
C. Cardiovascular
341 ................... ........................... ANSI/AAMI EC11:1991/(R)2007 Diagnostic electrocardiographic de-
vices.
Withdrawn. See 3106.
352 ................... ........................... ANSI/AAMIEC12:2000/(R)2010 Disposable ECG electrodes .............. Extent of recognition.
354 ................... ........................... ANSI/AAMI/ISO 7198:1998/2001/(R)2010 Cardiovascular im-
plantsTubular vascular prostheses.
Extent of recognition.
358 ................... ........................... ANSI/AAMI/ISO 5840:2005/(R)2010 Cardiovascular implantsCar-
diac valve prostheses.
Extent of recognition.
363 ................... ........................... ISO 11318 Second edition 20020801 Cardiac Defibrillators
Connector assembly DF1 for implantable defibrillatorsDimen-
sions and test requirements.
Extent of recognition.
372 ................... ........................... ANSI/AAMI EC53:1995/(R) 2008 ECG cables and leadwires ............. Extent of recognition.
373 ................... 3118 ............... ANSI/AAMI EC57:2012 Testing and reporting performance results
of cardiac rhythm and ST-segment measurement algorithms.
Withdrawn and replaced with
newer version.
375 ................... ........................... ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003,
Manual, electronic or automated sphygmomanometers.
Withdrawn. See 380, 3122 and
3123.
376 ................... ........................... ASTM F212908 Standard Test Method for Conducting Cyclic
Potentiodynamic Polarization Measurements to Determine the Cor-
rosion Susceptibility of Small Implant Devices.
Extent of recognition.
378 ................... ........................... ANSI/AAMI/IEC 80601230:2009 Medical electrical equipment
Part 230: Particular requirements for the basic safety and essen-
tial performance of automated noninvasive sphygmomanometers.
Extent of recognition.
380 ................... ........................... ANSI/AAMI/ISO 810601:2007/(R) 2013 Non-invasive sphyg-
momanometersPart 1: Requirements and test methods for non-
automated measurement type.
Reaffirmation.
383 ................... ........................... ANSI/AAMI/ISO 147085:2010 Implants for surgeryActive
implantable medical devicesPart 5: Circulatory support devices.
Extent of recognition.
385 ................... 3120 ............... ANSI/AAMI/ISO 255392:2012 Cardiovascular implants
Endovascular devicesPart 2: Vascular stents.
Withdrawn and replaced with
newer version.
388 ................... ........................... ASTM F251408 Standard Guide for Finite Element Analysis (FEA)
of Metallic Vascular Stents Subjected to Uniform Radial.
Extent of recognition.
390 ................... ........................... ISO 7198 First edition 19980801 Cardiovascular implantsTubu-
lar vascular prostheses.
Extent of recognition.
393 ................... ........................... ISO 255391:2003 First edition 20011113 AMENDMENT 1 2005
0715 Cardiovascular implantsEndovascular devicesPart 1:
Endovascular prostheses Amendment 1: Test methods.
Withdrawn. See 3121.
397 ................... 3122 ............... ISO 810602 Second edition 20130501 Non-invasive sphyg-
momanometersPart 2: Clinical validation of automated measure-
ment type.
Withdrawn and replace with newer
version.
398 ................... ........................... ISO 810602:2009 TECHNICAL CORRIGENDUM Published 2011
0215 Non-invasive sphygmomanometersPart 2: Clinical valida-
tion of automated measurement type.
Withdrawn. See 3122.
3100 ................. ........................... ANSI/AAMI/IEC 60601227:2011 Medical electrical equipment
Part 227: Particular requirements for the basic safety and essen-
tial performance of electrocardiographic monitoring equipment.
Withdrawn. See 3101.
3107 ................. 3123 ............... IEC 80601230 Edition 1.1 201307 Medical electrical equip-
mentPart 230: Particular requirements for the basic safety and
essential performance of automated non-invasive sphyg-
momanometers.
Withdrawn and replaced with
newer version.
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4917 Federal Register / Vol. 79, No. 20/ Thursday, January 30, 2014/ Notices
TABLE 1MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDSContinued
Old
recognition
No.
Replacement
recognition
No.
Title of standard
1
Change
3108 ................. ........................... IEC 80601230 (First edition 2009) Medical electrical equipment
Part 230: Particular requirements for the basic safety and essen-
tial performance of automated non-invasive sphygmomanometers
CORRIGENDUM 1.
Withdrawn. See 3123.
3113 ................. 3124 ............... ISO 7199 Second edition 20090415 Cardiovascular implants and
artificial organsBlood-gas exchangers (oxygenators) [Including:
AMENDMENT 1 (2012)].
Withdrawn and replaced with
newer version including amend-
ment.
3114 ................. 3119 ............... ISO 58413 Third edition 20134015 Implants for surgeryCar-
diac pacemakersPart 3: Low-profile connectors (IS1) for
implantable pacemakers.
Withdrawn and replace with newer
version.
D. Dental/ENT
450 ................... ........................... ADA Specification No.18:1992 Alginate Impression Materials .......... Extent of recognition.
462 ................... ........................... ISO 1563 Second edition 19900901 Dental alginate impression
material.
Withdrawn.
463 ................... ........................... ISO 1564 Second edition 19951101 Dental aqueous impression
materials based on agar.
Withdrawn.
486 ................... ........................... ANSI/ADA Specification No. 38 2000 (Reaffirmed 2010), Metal-Ce-
ramic Dental Restorative Systems.
Extent of recognition.
489 ................... ........................... ANSI/ADA Specification No. 53: 1999 (Reaffirmed 2008) Polymer-
Based Crowns and Bridge Materials.
Extent of recognition.
491 ................... ........................... ANSI/ADA Specification No. 80/ISO 7491:2000 (Reaffirmed 2013)
Dental MaterialsDetermination of Color Stability.
Reaffirmation and extent of rec-
ognition.
492 ................... ........................... ANSI/ADA Specification No. 88:2000 (Reaffirmed 2010) Dental Braz-
ing Alloys.
Reaffirmation and extent of rec-
ognition.
496 ................... ........................... ANSI/ADA Specification No. 30:2000 (Reaffirmed 2012) Dental Zinc
Oxide-Eugenol and Zinc Oxide Non-Eugenol Cements.
Reaffirmation and extent of rec-
ognition.
497 ................... ........................... ANSI/ADA Specification No. 57: (Reaffirmed 2012) Endodontic Seal-
ing Materials.
Extent of recognition.
4105 ................. ........................... ANSI/ADA Specification No. 75:1997 (Reapproved 2003) Resilient
Lining Materials for Removable DenturesPart 1: Short-Term Ma-
terials.
Extent of recognition.
4109 ................. ........................... ISO 13716 First edition 19990501 Dentistryreversible-irrevers-
ible hydrocolloid impression material system.
Withdrawn.
4126 ................. ........................... ISO 10477 Second edition 20041001 DentistryPolymer-based
crown and bridge materials.
Extent of recognition.
4130 ................. ........................... ADA Specification No. 17:1983 (Reaffirmed 2006) Denture Base
Temporary Relining Resins.
Extent of recognition.
4134 ................. 4207 ............... ISO 74941 Second edition 20110815 DentistryDental units
Part 1: General requirements and test methods.
Withdrawn and replaced with
newer version.
4135 ................. 4213 ............... ISO 101391 Second edition 20050215 DentistrySoft lining
materials for removable denturesPart 1: Materials for short-term
use [Including: TECHNICAL CORRIGENDUM 1 (2006)].
Withdrawn and replaced with
newer version including tech-
nical corrigendum.
4137 ................. ........................... ISO 6877 Second edition 20060401 DentistryRoot-canal
obturating points.
Extent of recognition.
4139 ................. ........................... ANSI/ADA Specification No. 48 (Reaffirmed 2009) Visible Light Cur-
ing Units.
Reaffirmation and extent of rec-
ognition.
4143 ................. 4208 ............... ANSI/ADA Specification No. 96:2012 Dental-Water-Based Cements Withdrawn and replaced with
newer version.
4144 ................. 4209 ............... ISO 24234 First edition 20041015 DentistryMercury and alloys
for dental amalgam [Including: AMENDMENT 1 (2011)].
Withdrawn and replaced with
newer version including amend-
ment.
4146 ................. ........................... ISO 22674 First edition 20061115 DentistryMetallic materials
for fixed and removable restorations and appliances.
Extent of recognition.
4149 ................. ........................... ANSI/ADA Specification No. 39/ISO 6874:2005 (Reaffirmed 2011) Pit
and Fissure Sealants.
Reaffirmation and extent of rec-
ognition.
4150 ................. ........................... ANSI/ADA Specification No. 19:2004/ISO 4823:2000 Dental
Elastometric Impression Materials.
Extent of recognition.
4151 ................. ........................... ISO 22112 First edition 20051101 DentistryArtificial teeth for
dental prostheses.
Extent of recognition.
4153 ................. ........................... ISO 99171 Second edition 20071001 DentistryWater-based ce-
mentsPart 1: Powder/liquid acid-base cements.
Extent of recognition.
4154 ................. 4210 ............... ISO 4823 Third edition 20001215 DentistryElastometric im-
pression materials [Including: AMENDMENT 1 (2000) TECHNICAL
CORRIGENDUM 1(2004)].
Withdrawn and replaced with
newer version including amend-
ment and technical corri-
gendum.
4155 ................. ........................... ISO 4823: Technical Corrigendum 1 Published 20040715Den-
tistryElastometric impression materialsThird Edition.
Withdrawn. See 4210.
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4918 Federal Register / Vol. 79, No. 20/ Thursday, January 30, 2014/ Notices
TABLE 1MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDSContinued
Old
recognition
No.
Replacement
recognition
No.
Title of standard
1
Change
4156 ................. ........................... ISO 4823 Third edition 20001215 Amendment 1 20070701
DentistryElastometric impression materialsThird Edition.
Withdrawn. See 4210.
4157 ................. ........................... ISO 3107 Third edition 20041001 DentistryZinc oxide/Eugenol
and zinc oxide/non-eugenol cementsThird edition.
Withdrawn. See 4198.
4159 ................. 4211 ............... ANSI/IEEE C63.19:2007 American National Standard Methods of
Measurement of Compatibility between Wireless Communications
Devices and Hearing Aids.
Withdrawn and replaced with
newer version.
4170 ................. 4212 ............... ANSI/ASA S3.362012 American National Standard Specification
for a Manikin for Simulated in situ Airborne Acoustic Measure-
ments.
Withdrawn and replaced with
newer version.
4178 ................. ........................... ISO 6872 Third edition 20080901 DentistryCeramic materials .. Extent of recognition.
4179 ................. ........................... ISO 7405 Second edition 20081215 DentistryEvaluation of bio-
compatibility of medical devices used in dentistry.
Extent of recognition.
4180 ................. ........................... ISO 9168 Third edition 20090715 DentistryHose connectors for
air driven dental handpieces.
Extent of recognition.
4181 ................. ........................... ISO 4049 Fourth edition 20091001 DentistryPolymer-based re-
storative materials.
Extent of recognition.
4182 ................. ........................... ISO 101392 Second edition 20090801 DentistrySoft lining
materials for removable denturesPart 2: Materials for long-term
use.
Extent of recognition.
4188 ................. ........................... ISO 99172 Second edition 20100415 DentistryWater-based
cementsPart 2: Resin-modified cements.
Extent of recognition.
4189 ................. ........................... ISO 101391:2005 TECHNICAL CORRIGENDUM 1 20060301
DentistrySoft lining materials for removable denturesPart 1:
Materials for short-term use.
Withdrawn. See 4213.
4195 ................. ........................... ISO 14801 Second edition 20071115 DentistryImplants-Dy-
namic fatigue test for endosseous dental implants.
Extent of recognition.
4196 ................. ........................... ANSI/ADA Specification No.69:2010/ISO 6872:2008 Dental Ce-
ramic.
Extent of recognition.
4198 ................. ........................... ISO 3107 Fourth edition 20110301 DentistryZinc oxide/eugenol
and zinc oxide/non-eugenol cements.
Extent of recognition.
4199 ................. ........................... ISO 6876 Third edition 20120601 DentistryRoot Canal Sealing
Materials.
Extent of recognition.
4200 ................. ........................... ISO 24234 First edition 20041015 DentistryMercury and alloys
for dental amalgam AMENDMENT 1.
Withdrawn. See 4209.
4201 ................. ........................... ISO 96932012 DentistryCompatibility testingMetal-ceramic sys-
tems.
Extent of recognition.
4205 ................. ........................... ISO 14457 First edition 20120915 DentistryHandpieces and mo-
tors.
Withdrawn. See 4206.
E. General
522 ................... ........................... ISO 27681 First edition 19891115 General tolerancesPart 1:
Tolerances for linear and angular dimensions without individual tol-
erance indications.
Extent of recognition.
523 ................... ........................... ISO 27682 First edition 19891115 General TolerancesPart 2:
Geometrical tolerances for features without individual tolerance in-
dications.
Extent of recognition.
536 ................... ........................... ISO/TR 16142 Second edition 20060115 Medical devicesGuid-
ance on the selection of standards in support of recognized essen-
tial principles of safety and performance of medical devices.
Extent of recognition.
537 ................... 581 ................. ISO 28591 Second edition 19991115 Sampling procedures for
inspection by attributesPart 1: Sampling schemes indexed by
acceptance quality limit (AQL) for lot-by-lot inspection [Including:
TECHNICAL CORRIGENDUM 1 (2001)].
Withdrawn and replaced with
newer version including tech-
nical corrigendum.
543 ................... ........................... ANSI/ESD S20.202007 For the Development of an Electrostatic
Discharge Control Program for Protection of Electrical and Elec-
tronic Parts, Assemblies and Equipment (Excluding Electrically Ini-
tiated Explosive Devices).
Extent of recognition.
545 ................... 579 ................. ASTM D738612 Standard Practice for Performance Testing of
Packages for Single Parcel Delivery Systems.
Withdrawn and replaced with new
version.
546 ................... ........................... ISO 28591:1999/Cor 1:2001 Sampling procedures for inspection by
attributesPart 1: Sampling schemes indexed by acceptance
quality limit (AQL) for lot-by-lot inspection.
Withdrawn. See 581.
547 ................... ........................... ISO 10012 First edition 20030115 Measurement management
systemsRequirements for measurement processes and meas-
uring equipment.
Extent of recognition.
550 ................... ........................... IEC 62366 Edition 1.0 200710 Medical devicesApplication of
usability engineering to medical devices.
Extent of recognition.
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4919 Federal Register / Vol. 79, No. 20/ Thursday, January 30, 2014/ Notices
TABLE 1MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDSContinued
Old
recognition
No.
Replacement
recognition
No.
Title of standard
1
Change
551 ................... 580 ................. ASTM D433213 Standard Practice for Conditioning Containers,
Packages, or Packaging Components for Testing.
Withdrawn and replaced with new
version.
553 ................... ........................... IEC 6060112 Edition 3.0 200703 Medical electrical equipment
Part 12: General requirements for basic safety and essential per-
formanceCollateral standard: Electromagnetic compatibilityRe-
quirements and tests.
Relevant guidance.
554 ................... ........................... ANSI/AAMI/IEC 6060112:2007/(R)2012 Medical electrical equip-
mentPart 12: General requirements for basic safety and essen-
tial performanceCollateral standard: Electromagnetic compat-
ibilityRequirements and tests.
Reaffirmation and relevant guid-
ance.
557 ................... ........................... ANSI/AAMI HE75:2009 Human factors engineeringDesign of
medical devices.
Extent of recognition.
558 ................... 582 ................. IEC 60601111 Edition 1.0:2010 Medical electrical equipment
Part 111: General requirements for basic safety and essential
performanceCollateral Standard: Requirements for medical elec-
trical equipment and medical electrical systems used in the home
healthcare environment [Including: TECHNICAL CORRIGENDUM
1 (2011)].
Withdrawn and replaced with
newer version including tech-
nical corrigendum.
562 ................... ........................... ANSI/ASQ Z1.42008 Sampling Procedures and Tables for Inspec-
tion by Attributes.
Extent of recognition.
566 ................... ........................... IEC 60601110 Edition 1.0: 200711 Medical electrical equip-
mentPart 110: General requirements for basic safety and es-
sential performanceCollateral Standard: Requirements for the
development of physiologic closed-loop controllers.
Extent of recognition.
567 ................... ........................... ANSI/AAMI/IEC 62366:2007/(R)2013 Medical devicesApplication
of usability engineering to medical devices.
Reaffirmation and extent of rec-
ognition.
569 ................... ........................... IEC 60601111 (First edition 2010) April 2011 Medical electrical
equipmentPart 111: General requirements for basic safety and
essential performanceCollateral Standard: Requirements for
medical electrical equipment and medical electrical systems used
in the home healthcare environment CORRIGENDUM 1.
Withdrawn. See 582.
F. General Hospital/General Plastic Surgery
613 ................... ........................... ISO 5951 First edition 19861215 Reusable all-glass or metal-
and-glass syringes for medical usePart 1: Dimensions.
Withdrawn.
614 ................... ........................... ISO 5952 First edition 19871215 Reusable all-glass or metal-
and-glass syringes for medical usePart 2: Design, performance
requirements and tests.
Withdrawn.
6117 ................. ........................... ASTM F217202 (Reapproved 2011) Standard Specification for
Blood/Intravenous Fluid/Irrigation Fluid Warmers.
Extent of recognition.
6142 ................. ........................... ANSI/AAMI II36:2004 Medical electrical equipmentPart 2: Par-
ticular requirements for safety of baby incubators.
Withdrawn. See 6230.
6143 ................. ........................... ANSI/AAMI II51:2004 Medical electrical equipmentPart 2: Par-
ticular requirements for safety of transport incubators.
Withdrawn. See 6231.
6150 ................. ........................... ASTM D716105 (Reapproved 2010) Standard Practice for Deter-
mination of Real Time Expiration Dating of Mature Medical Gloves
Stored Under Typical Warehouse Conditions.
Withdrawn.
6161 ................. 6301 ............... ISO 105551 Second edition 20130615 Corrected version 2013
0701 Intravascular cathetersSterile and single-use catheters
Part 1: General requirements.
Withdrawn and replaced with
newer version.
6163 ................. ........................... ISO 9626 First edition 19910901 AMENDMENT 1 20010601
Stainless steel needle tubing for the manufacture of medical de-
vices.
Withdrawn. See 6302.
6164 ................. 6303 ............... ISO 105555 Second edition 20130615 Intravascular catheters
Sterile and single-use cathetersPart 5: Over-needle peripheral
catheters.
Withdrawn and replaced with
newer version.
6170 ................. 6304 ............... ISO 78861 First edition 19931001 Sterile hypodermic syringes
for single usePart 1: Syringes for manual use [Including: TECH-
NICAL CORRIGENDUM 1 Published 19951101].
Withdrawn and replaced with
newer version including tech-
nical corrigendum.
6171 ................. 6305 ............... ISO 105553 Second edition 20130615 Intravascular catheters
Sterile and single-use cathetersPart 3: Central venous catheters.
Withdrawn and replaced with
newer version.
6176 ................. ........................... ASTM D710306 (Reapproved 2013) Standard Guide for Assess-
ment of Medical Gloves.
Extent of recognition.
6187 ................. 6306 ............... ASTM F1671/F1671M13 Standard Test Method for Resistance of
Materials Used in Protective Clothing to Penetration by Blood-
Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a
Test System.
Withdrawn and replaced with
newer version.
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4920 Federal Register / Vol. 79, No. 20/ Thursday, January 30, 2014/ Notices
TABLE 1MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDSContinued
Old
recognition
No.
Replacement
recognition
No.
Title of standard
1
Change
6233 ................. ........................... IEC 60601252 Edition 1.0 200912 Medical electrical equip-
mentPart 252: Particular requirements for basic safety and es-
sential performance of medical beds.
Withdrawn. See 6321.
6236 ................. 6307 ............... IEC 80601259 Edition 1.0 200810 Medical Electrical Equip-
mentPart 259: Particular requirements for the basic safety and
essential performance of screening thermographs for human feb-
rile temperature screening [Including: CORRIGENDUM 1 (April
2009)].
Withdrawn and replaced with
newer version including tech-
nical corrigendum.
6237 ................. ........................... IEC 80601259 (First edition 2008) Medical Electrical Equipment
Part 259: Particular requirements for the basic safety and essen-
tial performance of screening thermographs for human febrile tem-
perature screening CORRIGENDUM 1.
Withdrawn. See 6307.
6238 ................. 6308 ............... IEC 80601235 Edition 2.0 200910 Medical electrical equip-
mentPart 235: Particular requirements for the basic safety and
essential performance of heating devices using blankets, pads or
mattresses and intended for heating in medical use [Including:
CORRIGENDUM 1 (March 2012)].
Withdrawn and replaced with
newer version including tech-
nical corrigendum.
6245 ................. ........................... ISO 85364 Fifth edition 20101001 Infusion equipment for med-
ical usePart 4: Infusion sets for single use, gravity feed.
Withdrawn. See 6318.
6253 ................. ........................... ISO 10535 Second edition 20061215 Hoists for the transfer of
disabled personsRequirements and test methods.
Extent of recognition.
6264 ................. ........................... ISO 105551 First edition 19950615 AMENDMENT 1 199907
15 Sterile, single-use intravascular cathetersPart 1: General re-
quirements.
Withdrawn. See 6301.
6265 ................. ........................... ISO 105551 First edition 1995065 AMENDMENT 2 20040515
Sterile, single-use intravascular cathetersPart 1: General re-
quirements.
Withdrawn. See 6301.
6266 ................. ........................... ISO 105555 First edition 19960615 AMENDMENT 1 Sterile,
single-use intravascular cathetersPart 5: Over-needle peripheral
catheters.
Withdrawn. See 6303.
6267 ................. ........................... ISO 105555 1996 TECHNICAL CORRIGENDUM 1 Published
20020615 Sterile, single-use intravascular cathetersPart 5:
Over-needle peripheral catheters.
Withdrawn. See 6303.
6273 ................. ........................... ISO 23908 First edition 20110611 Sharps injury protectionRe-
quirements and test methodsSharps protection features for sin-
gle-use hypodermic needles, introducers for catheters and needles
used for blood sampling.
Extent of recognition.
6279 ................. ........................... IEC 60601219 (Second Edition 2009) Medical electrical equip-
mentPart 219: Particular requirements for the basic safety and
essential performance of infant incubators CORRIGENDUM 1.
Withdrawn. See 6319.
6280 ................. ........................... IEC 60601220 (Second edition 2009) Medical electrical equip-
mentPart 220: Particular requirements for the basic safety and
essential performance of infant transport incubators CORRI-
GENDUM 1.
Withdrawn. See 6320.
6281 ................. ........................... IEC 80601235 (Second edition 2009) Medical electrical equip-
mentPart 235: Particular requirements for the basic safety and
essential performance of heating devices using blankets, pads or
mattresses and intended for heating in medical use CORRI-
GENDUM 1.
Withdrawn. See 6308.
6283 ................. 6309 ............... USP 36NF31:2013 Sodium Chloride Irrigation ................................ Withdrawn and replaced with
newer version.
6284 ................. 6310 ............... USP 36NF31:2013 Sodium Chloride Injection ................................. Withdrawn and replaced with
newer version.
6285 ................. 6311 ............... USP 36NF31:2013 Nonabsorbable Surgical Suture ........................ Withdrawn and replaced with
newer version.
6286 ................. 3312 ............... USP 36NF31:2013 <881> Tensile Strength ....................................... Withdrawn and replaced with
newer version.
6287 ................. 6313 ............... USP 36NF31:2013 <861> SuturesDiameter .................................. Withdrawn and replaced with
newer version.
6288 ................. 6314 ............... USP 36NF 31:2013 <871> SuturesNeedle Attachment ................. Withdrawn and replaced with
newer version.
6289 ................. 6315 ............... USP 36NF31:2013 Sterile Water for Irrigation ................................... Withdrawn and replaced with
newer version.
6290 ................. 6316 ............... USP 36NF31:2013 Heparin Lock Flush Solution ............................... Withdrawn and replaced with
newer version.
6291 ................. 6317 ............... USP 36NF31:2013 Absorbable Surgical Suture ................................ Withdrawn and replaced with
newer version.
6292 ................. ........................... ISO 78861:1993 TECHNICAL CORRIGENDUM 1 Published 1995
1101 Sterile hypodermic syringes for single-usePart 1: Sy-
ringes for manual use.
Withdrawn. See 6304.
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4921 Federal Register / Vol. 79, No. 20/ Thursday, January 30, 2014/ Notices
TABLE 1MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDSContinued
Old
recognition
No.
Replacement
recognition
No.
Title of standard
1
Change
6298 ................. 6319 ............... IEC 60601219 Edition 2.0 200902 Medical electrical equip-
mentPart 219: Particular requirements for the basic safety and
essential performance of infant incubators [Including: CORRI-
GENDUM 1 (2012)].
Withdrawn and replaced with
newer version including tech-
nical corrigendum.
6299 ................. ........................... IEC 60601220 Edition 2.0 200902 Medical electrical equip-
mentPart 220: Particular requirements for the basic safety and
essential performance of infant transport incubators.
Withdrawn. See 6320.
G. In Vitro Diagnostics
7100 ................. ........................... ISO 15197 First edition 20030501 In Vitro diagnostic test sys-
temsRequirements for blood-glucose monitoring systems for
self-testing in managing diabetes mellitus.
Withdrawn.
7137 ................. 7244 ............... CLSI NBS01A6 Blood Collection on Filter Paper for Newborn
Screening Programs; Approved StandardSixth Edition.
Withdrawn and replaced with
newer version.
7239 ................. ........................... CLSI EP32R (Formerly X05R) Metrological Traceability and Its Im-
plementation; A Report.
Designation number.
7226 ................. ........................... CLSI QMS01A4 (Formerly GP26A4) Quality Management System:
A Model for Laboratory Services; Approved GuidelineFourth Edi-
tion.
Designation number.
7224 ................. ........................... CLSI EP28A3c (Formerly C28A3c) Defining, Establishing, and
Verifying Reference Intervals in the Clinical Laboratory; Approved
GuidelineThird Edition.
Designation number.
7223 ................. ........................... CLSI QSM06A3 (Formerly GP22A3) Quality Management System:
Continual Improvement; Approved GuidelineThird Edition.
Designation number.
792 ................... 7245 ............... CLSI EP09A3 Measurement Procedure Comparison and Bias Es-
timation Using Patient Samples; Approved GuidelineThird Edi-
tion.
Withdrawn and replaced with
newer version.
7210 ................. ........................... CLSI H26A2 Validation, Verification, and Quality Assurance of
Automated Hematology Analyzers; Approved StandardSecond
Edition.
Extent of recognition.
7152 ................. ........................... CLSI EP12A2 User Protocol for Evaluation of Qualitative Test
Performance; Approved GuidelineSecond Edition.
Extent of recognition.
7174 ................. ........................... CLSI EP21A Estimation of Total Analytical Error for Clinical Lab-
oratory Methods; Approved Guideline.
Extent of recognition.
7178 ................. ........................... CLSI M22A3 Quality Control for Commercially Prepared Micro-
biological Culture Media; Approved StandardThird Edition.
Extent of recognition.
7193 ................. ........................... CLSI EP06A Evaluation of the Linearity of Quantitative Measure-
ment Procedures: A Statistical Approach; Approved Guideline.
Extent of recognition.
7220 ................. ........................... CLSI H59A Quantitative D-dimer for the Exclusion of Venous
Thromboembolic Disease; Approved Guideline.
Extent of recognition.
H. Materials
867 ................... 8344 ............... ISO 71531 Second edition 19910401 Surgical instruments
Metallic materialsPart 1: Stainless steel [Including: AMEND-
MENT 1(1999)].
Withdrawn and replaced with
newer version including amend-
ment.
8138 ................. ........................... ASTM F74507 Standard Specification for 18 Chromium-12.5 Nick-
el-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed
Surgical Implant Applications.
Withdrawn.
8139 ................. 8345 ............... ASTM F131413 Standard Specification for Wrought Nitrogen
Strengthened 22 Chromium-13 Nickel-5 Manganese-2.5 Molyb-
denum Stainless Steel Alloy Bar and Wire for Surgical Implants
(UNS S20910).
Withdrawn and replaced with
newer version.
8140 ................. 8346 ............... ASTM F181313 Standard Specification for Wrought Titanium-12
Molybdenum-6 Zirconium-2 Iron Alloy for Surgical Implant (UNS
R58120).
Withdrawn and replaced with
newer version.
8141 ................. 8347 ............... ASTM F214613 Standard Specification for Wrought Titanium-3
Aluminum-2.5 Vanadium Alloy Seamless Tubing for Surgical Im-
plant Applications (UNS R56320).
Withdrawn and replaced with
newer version.
8169 ................. 8348 ............... ASTM F13813 Standard Specification for Wrought 18 Chromium-
14 Nickel-2.5 Molybendum Stainless Steel Bar and Wire for Sur-
gical Implants (UNS S31673).
Withdrawn and replaced with
newer version.
8176 ................. 8349 ............... ASTM F250313 Standard Practice for Marking Medical Devices
and Other Items for Safety in the Magnetic Resonance Environ-
ment.
Withdrawn and replaced with
newer version.
8149 ................. 8350 ............... ISO 58321 Fourth edition 20070615 Implants for surgeryMe-
tallic materialsPart 1: Wrought stainless steel [Including: TECH-
NICAL CORRIGENDUM 1(2008)].
Withdrawn and replaced with
newer version including tech-
nical corrigendum.
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4922 Federal Register / Vol. 79, No. 20/ Thursday, January 30, 2014/ Notices
TABLE 1MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDSContinued
Old
recognition
No.
Replacement
recognition
No.
Title of standard
1
Change
8196 ................. ........................... ISO 58321: 2007 Implants for surgeryMetallic materialsPart 1:
Wrought stainless steel TECHNICAL CORRIGENDUM 1.
Withdrawn. See 8350.
8151 ................. 8351 ............... ISO 583212 Second edition 20070501 Implants for surgery
Metallic materialsPart 12: Wrought cobalt-chromium-molyb-
denum alloy [Including: TECHNICAL CORRIGENDUM 1 2008].
Withdrawn and replaced with
newer version including tech-
nical corrigendum.
8197 ................. ........................... ISO 583212:2007 TECHNICAL CORRIGENDUM 1 20080905,
Implants for surgeryMetallic materialsPart 12: Wrought cobalt-
chromium-molybdenum alloy TECHNICAL CORRIGENDUM 1.
Withdrawn. See 8351.
8211 ................. 8352 ............... ISO 58341 Third edition 20050601 Implants for surgeryUltra-
high-molecular-weight polyethylenePart 1: Powder form [Includ-
ing: TECHNICAL CORRIGENDUM 1 2007].
Withdrawn and replaced with
newer version including tech-
nical corrigendum.
8212 ................. ........................... ISO 58341:2005 Technical Corrigendum 1 Published 20070501
Implants for surgeryUltra-high-molecular-weight polyethylene
Part 1: Powder form TECHNICAL CORRIGENDUM 1.
Withdrawn. See 8352.
8228 ................. 8353 ............... ASTM F8613 Standard Practice for Surface Preparation and
Marking of Metallic Surgical Implants.
Withdrawn and replaced with
newer version.
8175 ................. 8354 ............... ASTM F137713 Standard Specification for Cobalt-28 Chromium-6
Molybdenum Powder for Coating of Orthopedic Implants (UNS
R30075).
Withdrawn and replaced with
newer version.
8163 ................. 8355 ............... ASTM F1586/F 1586M13
1
Standard Specification for Wrought Ni-
trogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5
Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS
S31675).
Withdrawn and replaced with
newer version.
8129 ................. 8356 ............... ASTM F6713 Standard Specification for Unalloyed Titanium, for
Surgical Implant Applications (UNS R50250, UNS R50400, UNS
R50550, UNS R50700).
Withdrawn and replaced with
newer version.
8208 ................. 8357 ............... ASTM F64813 Standard Specification for Ultra-High-Molecular-
Weight Polyethylene Powder and Fabricated Form for Surgical Im-
plants.
Withdrawn and replaced with
newer version.
8103 ................. ........................... ASTM F180197 (Reapproved 2009)
1
Standard Practice for Corro-
sion Fatigue Testing of Metallic Implant Materials.
Extent of recognition.
8107 ................. ........................... ASTM F74604 (Reapproved 2009)
1
Standard Test Method for Pit-
ting or Crevice Corrosion of Metallic Surgical Implant Materials.
Extent of recognition.
8111 ................. ........................... ASTM F116005 (Reapproved 2011)
1
Standard Test Method for
Shear and Bending Fatigue Testing of Calcium Phosphate and
Metallic Medical and Composite Calcium Phosphate/Metallic Coat-
ings.
Extent of recognition.
8112 ................. ........................... ASTM F104405 (Reapproved 2011)
1
Standard Test Method for
Shear Testing of Calcium Phosphate Coatings and Metallic Coat-
ings.
Extent of recognition.
8113 ................. ........................... ASTM F114705 (Reapproved 2011) Standard Test Method for Ten-
sion Testing of Calcium Phosphate and Metal Coatings.
Extent of recognition.
8114 ................. ........................... ASTM F2255 (Reapproved 2010) Standard Test Method for Strength
Properties of Tissue Adhesives in Lap Shear by Tension Loading.
Extent of recognition.
8115 ................. ........................... ASTM F225605 (Reapproved 2010) Standard Test Method for
Strength Properties of Tissue Adhesives in T-Peel by Tension
Loading.
Extent of recognition.
8116 ................. ........................... ASTM F225805 (Reapproved 2010) Standard Test Method for
Strength Properties of Tissue Adhesives in Tension.
Extent of recognition.
8121 ................. ........................... ASTM F200505 (Reapproved 2010) Standard Terminology for Nick-
el-Titanium Shape Memory Alloys.
Extent of recognition.
8123 ................. ........................... ISO 58325 Third edition 20051015 Implants for surgeryMetal-
lic materialsPart 5: Wrought cobalt-chromium-tungsten-nickel
alloy.
Extent of recognition.
8124 ................. ........................... ASTM F205206

Standard Test Method for Measurement of Mag-

netically Induced Displacement Force on Medical Devices in the
Magnetic Resonance Environment.
Extent of recognition.
8125 ................. ........................... ASTM F200405 (Reapproved 2010) Standard Test Method for
Transformation Temperature of Nickel-Titanium Alloys by Thermal
Analysis.
Extent of recognition.
8126 ................. 8370 ............... ASTM F56113 Standard Practice for Retrieval and Analysis of
Medical Devices, and Associated Tissues and Fluids.
Withdrawn and replaced with
newer version.
8128 ................. ........................... ASTM F221306 (Reapproved 2011) Standard Test Method for
Measurement of Magnetically Induced Torque on Medical Devices
in the Magnetic Resonance Environment.
Extent of recognition.
8132 ................. ........................... ASTM F108804a (Reapproved 2010) Standard Specification for
Beta-Tricalcium Phosphate for Surgical Implantation.
Extent of recognition.
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4923 Federal Register / Vol. 79, No. 20/ Thursday, January 30, 2014/ Notices
TABLE 1MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDSContinued
Old
recognition
No.
Replacement
recognition
No.
Title of standard
1
Change
8134 ................. ........................... ASTM F208206 Standard Test Method for Determination of Trans-
formation Temperature of Nickel-Titanium Shape Memory Alloys
by Bend and Free Recovery.
Extent of recognition.
8135 ................. ........................... ASTM F239204 (Reapproved 2010) Standard Test Method for
Burst Strength of Surgical Sealants.
Extent of recognition.
8136 ................. ........................... ASTM F245805 (Reapproved 2010) Standard Test Method for
Wound Closure Strength of Tissue Adhesives and Sealants.
Extent of recognition.
8150 ................. ........................... ISO 58329 Second edition 20070615 Implants for surgeryMe-
tallic materialsPart 9: Wrought high nitrogen stainless steel.
Extent of recognition.
8157 ................. ........................... ISO 9583 First edition 19931015 Implants for surgeryNon-de-
structive testingLiquid penetrant inspection of metallic surgical
implants.
Extent of recognition.
8159 ................. ........................... ISO 9584 First edition 19931015 Implants for surgeryNon-de-
structive testingRadiographic examination of cast metallic sur-
gical implants.
Extent of recognition.
8165 ................. ........................... ASTM F105808
1
Standard Specification for Wrought 40 Cobalt-
20 Chromium-16 Iron-15 Nickel-7 Molybdenum Alloy Wire and
Strip for Surgical Implant Applications (UNS R30003 and UNS
R30008).
Extent of recognition.
8167 ................. ........................... ASTM F135008 Standard Specification for Wrought 18 Chromium-
14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire
(UNS S31673).
Extent of recognition.
8168 ................. ........................... ASTM F147208
1
Standard Specification for Wrought Titanium-6
Aluminum-4 Vanadium Alloy for Surgical Implant Applications
(UNS R56400).
Extent of recognition.
8170 ................. ........................... ASTM F96108 Standard Specification for 35 Cobalt-35 Nickel-20
Chromium-10 Molybdenum Alloy Forgings for Surgical Implants
(UNS R30035).
Extent of recognition.
8171 ................. ........................... ASTM F160908 Standard Specification for Calcium Phosphate
Coatings for Implantable Materials.
Extent of recognition.
8173 ................. ........................... ASTM F60103 (Reapproved 2008) Standard Practice for Fluores-
cent Penetrant Inspection of Metallic Surgical Implants.
Extent of recognition.
8177 ................. ........................... ASTM F212908 Standard Test Method for Conducting Cyclic
Potentiodynamic Polarization Measurements to Determine the Cor-
rosion Susceptibility of Small Implant Devices.
Extent of recognition.
8179 ................. ........................... ASTM F75408 Standard Specification for Implantable Polytetra-
fluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated
from Granular Molding Powders.
Extent of recognition.
8183 ................. ........................... ASTM F56008 Standard Specification for Unalloyed Tantalum for
Surgical Implant Applications (UNS R05200, UNS R05400).
Extent of recognition.
8184 ................. ........................... ASTM F251607
2
Standard Test Method for Tension Testing of
Nickel-Titanium Superelastic Materials.
Extent of recognition.
8185 ................. ........................... ASTM F45108 Standard Specification for Acrylic Bone Cement .... Extent of recognition.
8187 ................. ........................... ISO 137791 Second edition 20081001 Implants for surgery
HydroxyapatitePart 1: Ceramic hydroxyapatite.
Extent of recognition.
8188 ................. ........................... ISO 137792 Second edition 20081001 Implants for surgery
HydroxyapatitePart 2: Coatings of hydroxyapatite.
Extent of recognition.
8189 ................. ........................... ASTM F 110804 (Reapproved 2009) Standard Specification for Ti-
tanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Im-
plants (UNS R56406).
Extent of recognition.
8190 ................. ........................... ASTM F 9009 Standard Specification for Wrought Cobalt-20 Chro-
mium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applica-
tions (UNS R30605).
Extent of recognition.
8192 ................. ........................... ASTM F185409 Standard Test Method for Stereological Evaluation
of Porous Coatings on Medical Implants.
Extent of recognition.
8193 ................. ........................... ASTM F2754/F 2754M09 Standard Test Method for Measurement
of Camber, Cast, Helix and Direction of Helix of Coiled Wire.
Extent of recognition.
8194 ................. ........................... ISO 64741 First edition 20100215 Implants for surgeryCe-
ramic materialsPart 1: Ceramic materials based on high purity
alumina.
Extent of recognition.
8195 ................. ........................... ASTM F202410 Standard Practice for X-Ray Diffraction Deter-
mination of Phase Content of Plasma-Sprayed Hydroxyapatite
Coatings.
Extent of recognition.
8199 ................. ........................... ASTM F263307 Standard Specification for Wrought Seamless
Nickel-Titanium Shape Memory Alloy Tube for Medical Devices
and Surgical Implants.
Extent of recognition.
8204 ................. ........................... ASTM F211810 Standard Test Method for Constant Amplitude of
Force Controlled Fatigue Testing of Acrylic Bone Cement Materials.
Extent of recognition.
8205 ................. ........................... ASTM F163511 Standard Test Method for In Vitro Degradation
Testing of Hydrolytically Degradable Polymer Resins and Fab-
ricated Forms for Surgical Implants.
Extent of recognition.
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4924 Federal Register / Vol. 79, No. 20/ Thursday, January 30, 2014/ Notices
TABLE 1MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDSContinued
Old
recognition
No.
Replacement
recognition
No.
Title of standard
1
Change
8206 ................. ........................... ASTM F68810 Standard Specification for Wrought Cobalt-35 Nick-
el-20 Chromium-10 Molybdenum Alloy Plate, Sheet, and Foil for
Surgical Implants (UNS R30035).
Extent of recognition.
8207 ................. ........................... ASTM F1926/F1926M10 Standard Test Method for Evaluation of
the Environmental Stability of Calcium Phosphate Granules, Fab-
ricated Forms, and Coatings.
Extent of recognition.
8213 ................. ........................... ISO 58343 First edition 20050715 Implants for surgeryUltra-
high-molecular-weight polyethylenePart 3: Accelerated ageing
methods.
Extent of recognition.
8214 ................. ........................... ISO 58344 First edition 20050501 Implants for surgeryUltra-
high-molecular-weight polyethylenePart 4: Oxidation index
measurement method.
Extent of recognition.
8215 ................. ........................... ISO 58345 First edition 20050601 Implants for surgeryUltra-
high-molecular-weight polyethylenePart 5: Morphology assess-
ment method.
Extent of recognition.
8216 ................. ........................... ASTM F129511 Standard Specification for Wrought Titanium-6
Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS
R56700).
Extent of recognition.
8217 ................. ........................... ASTM F62011 Standard Specification for Alpha Plus Beta Tita-
nium Alloy Forgings for Surgical Implants.
Extent of recognition.
8218 ................. ........................... ASTM F79911 Standard Specification for Cobalt-28 Chromium-6
Molybdenum Alloy Forgings for Surgical Implants (UNS R31537,
R31538, R31539).
Extent of recognition.
8220 ................. ........................... ASTM F62911 Standard Practice for Radiography of Cast Metallic
Surgical Implants.
Extent of recognition.
8221 ................. ........................... ASTM F206611 Standard Specification for Wrought Titanium-15
Molybdenum Alloy for Surgical Implant Applications (UNS R58150).
Extent of recognition.
8224 ................. ........................... ASTM F210206
1
Standard Guide for Evaluating the Extent of Oxi-
dation in Ultra-High-Molecular-Weight Polyethylene Fabricated
Forms Intended for Surgical Implants.
Extent of recognition.
8225 ................. ........................... ASTM F200302 (Reapproved 2008) Standard Practice for Accel-
erated Aging of Ultra-High Molecular Weight Polyethylene after
Gamma Irradiation in Air.
Extent of recognition.
8226 ................. ........................... ASTM F60312 Standard Specification for High-Purity Dense Alu-
minum Oxide for Medical Application.
Extent of recognition.
8229 ................. ........................... ASTM F7512 Standard Specification for Cobalt-28 Chromium-6
Molybdenum Alloy Castings and Casting Alloy for Surgical Im-
plants (UNS R30075).
Extent of recognition.
8330 ................. ........................... ASTM F197812 Standard Test Method for Measuring Abrasion
Resistance of Metallic Thermal Spray Coatings by Using the Taber
Abraser.
Extent of recognition.
8331 ................. ........................... ASTM F158012 Standard Specification for Titanium and Titanium-
6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical
Implants.
Extent of recognition.
8333 ................. ........................... ASTM F239312 Standard Specification for High-Purity Dense
Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Im-
plant Applications.
Extent of recognition.
8334 ................. ........................... ASTM F245912 Standard Test Method for Extracting Residue
from Metallic Medical Components and Quantifying via Gravimetric
Analysis.
Extent of recognition.
I. Nanotechnology
181 ................... ........................... ASTM E249009 Standard Guide for Measurement of Particle Size
Distribution of Nanomaterials in Suspension by Photon Correlation
Spectroscopy (PCS).
Extent of recognition.
182 ................... ........................... ASTM E253507 (Reapproved 2013) Standard Guide for Handling
Unbound Engineered Nanoscale Particles in Occupational Settings.
Reaffirmation and extent of rec-
ognition.
J. Neurology
173 ................... 1712 ............... ISO 7197 Third edition 20060601 Neurosurgical ImplantsSter-
ile, single-use hydrocephalus shunts and components [Including
TECHNICAL CORRIGENDUM 1 (2007)].
Withdrawn and replaced with
newer version including tech-
nical corrigendum.
177 ................... ........................... ISO 7197: 2006 Neurosurgical implantsSterile, single-use hydro-
cephalus shunts and components TECHNICAL CORRIGENDUM 1.
Withdrawn. See 1712.
171 ................... ........................... ANSI/AAMI NS28:1988/(R) 2010 Intracranial pressure monitoring de-
vices.
Extent of recognition.
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4925 Federal Register / Vol. 79, No. 20/ Thursday, January 30, 2014/ Notices
TABLE 1MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDSContinued
Old
recognition
No.
Replacement
recognition
No.
Title of standard
1
Change
174 ................... ........................... ASTM F64794 (Reapproved 2006) Standard Practice for Evaluating
and Specifying Implantable Shunt Assemblies for Neurosurgical
Application.
Extent of recognition.
179 ................... ........................... ASTM F212908 Standard Test Method for Conducting Cyclic
Potentiodynamic Polarization Measurements to Determine the Cor-
rosion Susceptibility of Small Implant Devices.
Extent of recognition.
K. OBGYN/Gastroenterology/Urology
934 ................... 982 ................. ISO 4074 First edition 20020215 Corrected version 20021201
Natural latex rubber condomsRequirements and test methods
[Including TECHNICAL CORRIGENDUM 1 (2002), TECHNICAL
CORRIGENDUM 2 (2002)].
Withdrawn and replaced with
newer version including tech-
nical corrigendum.
957 ................... ........................... ISO 4074:2002 TECHNICAL CORRIGENDUM 2, Natural latex rub-
ber condomsRequirements and test methods TECHNICAL COR-
RIGENDUM 2.
Withdrawn. See 982.
975 ................... 984 ................. ISO 86003 First edition 19970701 Optics and Optical instru-
mentsMedical endoscopes and endoscopic accessoriesPart 3:
Determination of field of view and direction of view of endoscopes
with optics [Including AMENDMENT 1 (2003)].
Withdrawn and replaced with
newer version including amend-
ment.
936 ................... 990 ................. ISO 8009 First edition 20041001 Mechanical contraceptives
Reusable natural and silicone rubber contraceptive diaphragms
Requirements and tests [Including AMENDMENT 1(2012)].
Withdrawn and replaced with
newer version including amend-
ment.
937 ................... 983 ................. ISO 86001 Third edition 20130301 EndoscopesMedical
endoscopes and endotherapy devicesPart 1: General require-
ments.
Withdrawn and replaced with
newer version.
938 ................... ........................... ISO 86003 First edition 19970701 AMENDMENT 1, Optics and
optical instrumentsMedical endoscopes and endoscopic acces-
sories Part 3: Determination of field of view and direction of view
of endoscopes with optics.
Withdrawn. See 984.
944 ................... ........................... ASTM F62399 (Reapproved 2006) Standard Performance Speci-
fication for Foley Catheter.
Extent of recognition.
954 ................... 985 ................. ASTM D697613 Standard Specification for Rubber Contracep-
tivesVaginal Diaphragms.
Withdrawn and replaced with a
newer version.
956 ................... ........................... ASTM D349208 Standard Specification for Rubber Contraceptives
(Male Condoms).
Extent of recognition.
965 ................... 991 ................. ANSI/AAMI/ISO 8637:2010 Cardiovascular implants and
extracorporeal systemsHemodialyzers, hemodiafilters,
hemofilters, and hemoconcentrators [Including AMENDMENT 1
(2013)].
Withdrawn and replaced with
newer version including amend-
ment.
966 ................... ........................... ANSI/AAMI/ISO 8638:2010 Cardiovascular implants and
Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and
hemofilters.
Extent of recognition.
967 ................... ........................... ASTM D766110 Standard Test Method for Determining Compat-
ibility of Personal Lubricants with Natural Rubber Latex Condoms.
Extent of recognition.
968 ................... ........................... ISO 23409 First edition 20110215 Male CondomsRequire-
ments and test methods for condoms made from synthetic mate-
rials.
Extent of recognition.
973 ................... ........................... ANSI/AAMI/ISO 13958:2009 Concentrates for hemodialysis and re-
lated therapies.
Extent of recognition.
974 ................... ........................... ISO 13958 Second edition 20090415 Concentrates for
haemodialysis and related therapies.
Extent of recognition.
979 ................... ........................... ISO 26722 First edition 20090415 Water treatment equipment for
haemodialysis applications and related therapies.
Extent of recognition.
L. Ophthalmic
1041 ................. 1081 ............... ISO 119797 Second edition 20060501 Ophthalmic implants
Intraocular lensesPart 7: Clinical investigations [Including
Amendment 1:2012].
Withdrawn and replaced with
newer version including amend-
ment.
1075 ................. ........................... ISO 119797/Amendment 1:2012 Ophthalmic implantsIntraocular
lensesPart 7: Clinical investigations.
Withdrawn. See 1081.
1042 ................. 1082 ............... ISO 119792 First edition 19991215 Ophthalmic implantsIntra-
ocular lensesPart 2: Optical properties and test methods [Includ-
ing TECHNICAL CORRIGENDUM 1 (2003)].
Withdrawn and replaced with
newer version including tech-
nical corrigendum.
1053 ................. 1083 ............... ISO 183691 First edition 20060815 Ophthalmic opticsContact
lensesPart 1: Vocabulary, classification system and rec-
ommendations for labeling specifications [Including AMENDMENT
1 2009].
Withdrawn and replaced with
newer version including amend-
ment.
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4926 Federal Register / Vol. 79, No. 20/ Thursday, January 30, 2014/ Notices
TABLE 1MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDSContinued
Old
recognition
No.
Replacement
recognition
No.
Title of standard
1
Change
1061 ................. ........................... ISO 183691:2006 Ophthalmic opticsContact lenses Part 1: Vo-
cabulary, classification system and recommendations for labeling
specifications. ISO 183691 First edition 20060805 AMEND-
MENT 1 20090215.
Withdrawn. See 1083.
1058 ................. 1084 ............... ANSI Z80.112012 American National Standard for Ophthalmics
Laser Systems for Corneal Reshaping.
Withdrawn and replaced with
newer version.
1059 ................. 1085 ............... ISO 11980 Third edition 20121115 Corrected version 20131201
Ophthalmic opticsContact lenses and contact lens care prod-
uctsGuidance for clinical investigations.
Withdrawn and replaced with
newer version.
1071 ................. 1086 ............... ISO 14729 First edition 20010415 Ophthalmic opticsContact
lens care productsMicrobiological requirements and test meth-
ods for products and regimens for hygienic management of con-
tact lenses [Including: AMENDMENT 1 2010].
Withdrawn and replaced with
newer version including amend-
ment.
1043 ................. ........................... ISO 119798 Second edition 20060701 Ophthalmic implants
Intraocular lensesPart 8: Fundamental requirements.
Extent of recognition.
1054 ................. ........................... ISO 183694 First edition 20060815 Ophthalmic opticscontact
lensesPart 4: Physicochemical properties of contact lens mate-
rials.
Extent of recognition.
1055 ................. ........................... ISO 119796 Second edition 20070715 Ophthalmic implants
Intraocular lensesPart 6: Shelf-life and transport stability.
Extent of recognition.
1056 ................. ........................... ANSI Z80.122007 (R2012) American National Standard for
OphthalmicsMultifocal Intraocular Lenses.
Reaffirmation and extent of rec-
ognition.
1057 ................. ........................... ANSI Z80.132007 (R2012) American National Standard for
OphthalmicsPhakic Intraocular Lenses.
Reaffirmation and extent of rec-
ognition.
1060 ................. ........................... ISO 11981 Second edition 20090701 Ophthalmic opticsCon-
tact lenses and contact lens care productsDetermination of
physical compatibility of contact lens care products with contact
lenses.
Extent of recognition.
1062 ................. ........................... ANSI Z80.102009 Ophthalmic InstrumentsTonometers ............... Extent of recognition.
1064 ................. 1089 ............... ANSI Z80.72013 OphthalmicsIntraocular Lenses ........................ Withdrawn and replaced with
newer version.
1068 ................. ........................... ISO 13212 Second edition 20110515 Ophthalmic opticsCon-
tact lens care productsGuidelines for determination of shelf-life.
Extent of recognition.
1069 ................. ........................... ANSI Z80.182010 American National Standard for Ophthalmics
Contact Lens Care ProductsVocabulary, Performance Specifica-
tions and Test Methodology.
Extent of recognition.
1074 ................. ........................... ISO 10940 Second edition 20090801 Ophthalmic instruments
Fundus Cameras.
Extent of recognition.
M. Orthopedic
11190 ............... 11256 ............. ISO 142433 First edition 20040915 Implants for surgeryWear
of total knee-joint prosthesesPart 3: Loading and displacement
parameters for wear-testing machines with displacement control
and corresponding environmental conditions for test [Including:
TECHNICAL CORRIGENDUM 1(2006)].
Withdrawn and replaced with
newer version including tech-
nical corrigendum.
11218 ............... ........................... ISO 142433:2004 TECHNICAL CORRIGENDUM 1 Implants for
surgeryWear of total knee-joint prosthesesPart 3: Loading and
displacement parameters for wear-testing machines with displace-
ment control and corresponding environmental conditions for test.
Withdrawn. See 11256.
11210 ............... 11257 ............. ASTM F54313 Standard Specification and Test Methods for Me-
tallic Medical Bone Screws.
Withdrawn and replaced with a
newer version.
11212 ............... ........................... ASTM F144092 (Reapproved 2008) Standard Practice for Cyclic
Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral
Components Without Torsion.
Withdrawn.
11241 ............... ........................... ASTM F54307 Standard Specification and Test Methods for Me-
tallic Medical Bone Screws.
Withdrawn duplicate.
See 11257.
11244 ............... 11258 ............. ASTM F208312 Standard Specification for Knee Replacement
Prosthesis.
Withdrawn and replaced with a
newer version.
1174 ................. ........................... ISO 58382 First edition 19910115 Implants for surgerySkel-
etal pins and wiresPart 2: Steinmann skeletal pinsDimensions.
Extent of recognition.
1175 ................. ........................... ISO 58383 First edition 19930915 Implants for surgerySkel-
etal pins and wiresPart 3: Kirschner skeletal wires.
Extent of recognition.
1180 ................. ........................... ISO 8828 First edition 19881015 Implants for surgeryGuidance
on care and handling of orthopaedic implants.
Extent of recognition.
1183 ................. ........................... ISO 13402 First edition 19950801 Surgical and dental hand in-
strumentsDetermination of resistance against autoclaving, corro-
sion and thermal exposure.
Extent of recognition.
11168 ............... ........................... ASTM F178103 (Reapproved 2009) Standard Specification for
Elastomeric Flexible Hinge Finger Total Joint Implants.
Extent of recognition.
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4927 Federal Register / Vol. 79, No. 20/ Thursday, January 30, 2014/ Notices
TABLE 1MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDSContinued
Old
recognition
No.
Replacement
recognition
No.
Title of standard
1
Change
11171 ............... ........................... ASTM F181497a (Reapproved 2009) Standard Guide for Evaluating
Modular Hip and Knee Joint Components.
Extent of recognition.
11183 ............... ........................... ASTM F187598 (Reapproved 2009) Standard Practice for Fretting
Corrosion Testing of Modular Implant Interfaces: Hip Femoral
Head-bore and Cone Taper Interface.
Extent of recognition.
11184 ............... ........................... ISO 8827 First edition 19881015 Implants for surgeryStaples
with parallel legs for orthopaedic useGeneral requirements.
Extent of recognition.
11185 ............... ........................... ASTM F226704 (Reapproved 2011) Standard Test Method for
Measuring Load Induced Subsidence of Intervertebral Body Fusion
Device Under Static Axial Compression.
Extent of recognition.
11191 ............... ........................... ISO 148791 First edition 20000601 Implants for surgeryTotal
knee-joint prosthesesPart 1: Determination of endurance prop-
erties of knee tibial trays.
Extent of recognition.
11196 ............... ........................... ASTM F167295 (Reapproved 2011) Standard Specification for Re-
surfacing Patellar Prosthesis.
Extent of recognition.
11197 ............... ........................... ASTM F98386 (Reapproved 2013) Standard Practice for Perma-
nent Marking of Orthopaedic Implant Components.
Reaffirmation and extent of rec-
ognition.
11199 ............... ........................... ASTM F56504 (Reapproved 2013) Standard Practice for Care and
Handling of Orthopedic Implants and Instruments.
Reaffirmation and extent of rec-
ognition.
11203 ............... ........................... ASTM F154102 (Reapproved 2011)
1
Standard Specification and
Test Methods for External Skeletal Fixation Devices.
Extent of recognition.
11207 ............... ........................... ASTM F219302 (Reapproved 2007) Standard Specifications and
Test Methods for Components Used in the Surgical Fixation of the
Spinal Skeletal System.
Extent of recognition.
11211 ............... ........................... ASTM F179897 (Reapproved 2008) Standard Guide for Evaluating
the Static and Fatigue Properties of Interconnection Mechanisms
and Subassemblies Used in Spinal Arthrodesis Implants.
Extent of recognition.
11214 ............... ........................... ASTM F38299 (Reapproved 2008)
1
Standard Specification and
Test Method for Metallic Bone Plates.
Extent of recognition.
11216 ............... ........................... ASTM F126403 (Reapproved 2012) Standard Specification and
Test Methods for Intramedullary Fixation Devices.
Extent of recognition.
11220 ............... ........................... ASTM F206809 Standard Specification for Femoral Prostheses
Metallic Implants.
Extent of recognition.
11222 ............... ........................... ISO 142431 Second edition 20091115 Implants for surgery
Wear of total knee-joint prosthesesPart 1: Loading and displace-
ment parameters for wear-testing machines with load control and
corresponding environmental conditions for test.
Extent of recognition.
11223 ............... ........................... ISO 142432 Second edition 20091115 Implants for surgery
Wear of total knee-joint prosthesesPart 2: Methods of measure-
ment.
Extent of recognition.
11224 ............... ........................... ASTM F270608 Standard Test Methods for Occipital-Cervical and
Occipital-Cervical-Thoracic Spinal Implant Constructs in a
Vertebrectomy Model.
Extent of recognition.
11225 ............... ........................... ISO 72064 Third edition 20100615 Implants for surgeryPartial
and total hip-joint prosthesesPart 4: Determination of endurance
properties and performance of stemmed femoral components.
Extent of recognition.
11226 ............... ........................... ASTM F108910 Standard Test Method for Corrosion of Surgical
Instruments.
Extent of recognition.
11227 ............... ........................... ASTM F36610 Standard Specification for Fixation Pins and Wires .. Extent of recognition.
11228 ............... ........................... ASTM F56410 Standard Specification and Test Methods for Metal-
lic Bone Staples.
Extent of recognition
11231 ............... ........................... ISO 72072 Second edition 20110701 Implants for surgery
Components for partial and total knee joint prosthesesPart 2: Ar-
ticulating surfaces made of metal, ceramic and plastics materials.
Extent of recognition.
11232 ............... ........................... ISO 72071 Third edition 20070201 Implants for surgeryCompo-
nents for partial and total knee joint prosthesesPart 1: Classifica-
tion, definitions and designation of dimensions.
Extent of recognition.
11234 ............... ........................... ASTM F73200 (Reapproved 2011) Standard Test Method for Wear
Testing of Polymeric Materials Used in Total Joint Prostheses.
Extent of recognition.
11235 ............... ........................... ASTM F207711 Test Methods for Intervertebral Body Fusion De-
vices.
Extent of recognition.
11237 ............... ........................... ISO 72066 First edition 19920315 Implants for surgeryPartial
and total hip joint prosthesesPart 6: Determination of endurance
properties of head and neck region of stemmed femoral compo-
nents.
Extent of recognition.
11238 ............... ........................... ASTM F203312 Standard Specification for Total Hip Joint Pros-
thesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic,
Ceramic, and Polymeric Materials.
Extent of recognition.
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4928 Federal Register / Vol. 79, No. 20/ Thursday, January 30, 2014/ Notices
TABLE 1MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDSContinued
Old
recognition
No.
Replacement
recognition
No.
Title of standard
1
Change
11239 ............... ........................... ASTM F 234503 (Reapproved 2013) Standard Test Methods for
Determination of Static and Cyclic Fatigue Strength of Ceramic
Modular Femoral Heads.
Extent of recognition. Reaffirma-
tion.
11240 ............... ........................... ASTM F38299 (Reapproved 2008)
1
Standard Specification and
Test Method for Metallic Bone Plates.
Extent of recognition.
11243 ............... ........................... ASTM F234605 (Reapproved 2011) Standard Test Methods for
Static and Dynamic Characterization of Spinal Artificial Discs.
Extent of recognition.
11245 ............... ........................... ASTM F38412 Standard Specifications and Test Methods for Metal-
lic Angled Orthopedic Fracture Fixation Devices.
Extent of recognition.
11247 ............... ........................... ASTM F278910 Standard Guide for Mechanical and Functional
Characterization of Nucleus Devices.
Extent of recognition.
11248 ............... ........................... ISO 142421 Second edition 20120115 Implants for surgery
Wear of total hip-joint prosthesesPart 1: Loading and displace-
ment parameters for wear-testing machines and corresponding en-
vironmental conditions for test.
Extent of recognition.
11249 ............... ........................... ISO 142422 First edition 20000915 Implants for surgeryWear
of total hip-joint prosthesesPart 2: Methods of measurement.
Extent of recognition.
11250 ............... ........................... ISO 142423 First edition 20090315 Implants for surgeryWear
of total hip-joint prosthesesPart 3: Loading and displacement pa-
rameters for orbital bearing type wear testing machines and cor-
responding environmental conditions for test.
Extent of recognition.
N. Physical Medicine
1625 ................. ........................... ISO 717613 First edition 19890801 WheelchairsPart 13: De-
termination of coefficient of friction of test surfaces.
Extent of recognition.
1627 ................. ........................... ISO 717615 First edition 19961115 WheelchairsPart 15: Re-
quirements for information disclosure, documentation and labeling.
Extent of recognition.
1629 ................. ........................... ISO 71766 Second edition 20011001 WheelchairsPart 6: De-
termination of maximum speed, acceleration and deceleration of
electric wheelchairs.
Extent of recognition.
16158 ............... ........................... ISO 71761 Second edition 19991001 WheelchairsPart 1: De-
termination of static stability.
Extent of recognition.
16159 ............... ........................... ISO 71762 Second edition 20010615 WheelchairsPart 2: De-
termination of dynamic stability of electric wheelchairs.
Extent of recognition.
16162 ............... ........................... ISO 71764 Third edition 20081001 WheelchairsPart 4: Energy
consumption of electric wheelchairs and scooters for determination
of theoretical distance range.
Extent of recognition.
16163 ............... ........................... ISO 71765 Second edition 20080601 WheelchairsPart 5: De-
termination of overall dimensions, mass and manoeuvring space.
Extent of recognition.
16164 ............... ........................... ISO 717610 Second edition 20081101 WheelchairsPart 10:
Determination of obstacle-climbing ability of electrically powered
wheelchairs.
Extent of recognition.
16165 ............... ........................... ISO 717614 Second edition 20080215 WheelchairsPart 14:
Power and control systems for electrically powered wheelchairs
and scootersRequirements and test methods.
Extent of recognition.
16166 ............... ........................... ISO 717621 Second edition 20090401 WheelchairsPart 21:
Requirements and test methods for electromagnetic compatibility
of electrically powered wheelchairs and scooters, and battery char-
gers.
Extent of recognition.
16167 ............... ........................... ISO 71769: Third edition 20091115 WheelchairsPart 9: Cli-
matic tests for electric wheelchairs.
Extent of recognition.
16168 ............... ........................... ANSI/RESNA WC1:2009 American National Standard for Wheel-
chairsVolume 1: Requirements and Test Methods for Wheel-
chairs (including Scooters) Section 1: Determination of static sta-
bility.
Extent of recognition.
16169 ............... ........................... ANSI/RESNA WC2:2009 American National Standard for Wheel-
chairsVolume 2: Additional Requirements for Wheelchairs (in-
cluding Scooters) with Electrical Systems Section 2: Determination
of dynamic stability of electrically powered wheelchairs.
Extent of recognition.
16170 ............... ........................... ANSI/RESNA WC2:2009 American National Standard for Wheel-
chairsVolume 2: Additional Requirements for Wheelchairs (in-
cluding Scooters) with Electrical Systems Section 3: Determination
of effectiveness of brakes.
Extent of recognition.
16171 ............... ........................... ANSI/RESNA WC2:2009 Section 4: Energy consumption of elec-
trically powered wheelchairs and scooters for determination of the-
oretical distance range.
Extent of recognition.
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4929 Federal Register / Vol. 79, No. 20/ Thursday, January 30, 2014/ Notices
TABLE 1MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDSContinued
Old
recognition
No.
Replacement
recognition
No.
Title of standard
1
Change
16172 ............... ........................... ANSI/RESNA WC1:2009 American National Standard for Wheel-
chairsVolume 1: Requirements and Test Methods for Wheel-
chairs (including Scooters) Section 5: Determination of dimen-
sions, mass and maneuvering space.
Extent of recognition.
16173 ............... ........................... ANSI/RESNA WC2:2009 American National Standard for Wheel-
chairsVolume 2: Additional Requirements for Wheelchairs (in-
cluding Scooters) with Electrical Systems Section 6: Determination
of maximum speed, acceleration and deceleration of electrically
powered wheelchairs.
Extent of recognition.
16174 ............... ........................... ANSI/RESNA WC1:2009 American National Standard for Wheel-
chairs Volume 1: Requirements and Test Methods for Wheelchairs
(including Scooters) Section 7: Method of Measurement of Seating
and Wheel Dimensions.
Extent of recognition.
16175 ............... ........................... ANSI/RESNA WC1:2009 American National Standard for Wheel-
chairsVolume 1: Requirements and Test Methods for Wheel-
chairs (including Scooters) Section 8: Requirements and test
methods for static, impact and fatigue strengths.
Extent of recognition.
16176 ............... ........................... ANSI/RESNA WC2:2009 American National Standard for Wheel-
chairsVolume 2: Additional Requirements for Wheelchairs (in-
cluding Scooters) with Electrical Systems Section 9: Climatic tests
for electrically powered wheelchairs.
Extent of recognition.
16177 ............... ........................... ANSI/RESNA WC2:2009 American National Standard for Wheel-
chairsVolume 2: Additional Requirements for Wheelchairs (in-
cluding Scooters) with Electrical Systems Section 10: Determina-
tion of obstacle-climbing ability of electrically powered wheelchairs.
Extent of recognition.
16178 ............... ........................... ANSI/RESNA WC1:2009 American National Standard for Wheel-
chairsVolume 1: Requirements and Test Methods for Wheel-
chairs (including Scooters) Section 11: Test dummies.
Extent of recognition.
16179 ............... ........................... ANSI/RESNA WC1:2009 American National Standard for Wheel-
chairsVolume 1: Requirements and Test Methods for Wheel-
chairs (including Scooters) Section 13: Determination of coefficient
of friction of test surfaces.
Extent of recognition.
16180 ............... ........................... ANSI/RESNA WC2:2009 American National Standard for Wheel-
chairsVolume 2: Additional Requirements for Wheelchairs (in-
cluding Scooters) with Electrical Systems Section 14: Power and
control systems for electrically powered wheelchairsRequire-
ments and test methods.
Extent of recognition.
16181 ............... ........................... ANSI/RESNA WC1:2009 American National Standard for Wheel-
chairsVolume 1: Requirements and Test Methods for Wheel-
chairs (including Scooters) Section 15: Requirements for informa-
tion disclosure, documentation and labeling.
Extent of recognition.
16182 ............... ........................... ANSI/RESNA WC1:2009 American National Standard for Wheel-
chairsVolume 1: Requirements and Test Methods for Wheel-
chairs (including Scooters) Section 16: Resistance to ignition of
upholstered partsRequirements and test methods.
Extent of recognition.
16183 ............... ........................... ANSI/RESNA WC1:2009 American National Standard for Wheel-
chairsVolume 1: Requirements and Test Methods for Wheel-
chairs (including Scooters) Section 20: Determination of the per-
formance of stand-up type wheelchairs.
Extent of recognition
16184 ............... ........................... ANSI/RESNA WC1:2009 American National Standard for Wheel-
chairsVolume 1: Requirements and Test Methods for Wheel-
chairs (including Scooters) Section 22: Set-up procedures.
Extent of recognition.
16185 ............... ........................... ANSI/RESNA WC2:2009,American National Standard for Wheel-
chairsVolume 2, Additional Requirements for Wheelchairs (in-
cluding Scooters) with Electrical Systems Section 21: Require-
ments and test methods for electromagnetic compatibility of elec-
trically powered wheelchairs and motorized scooters.
Extent of recognition.
16187 ............... ........................... ANSI/RESNA WC1:2009 American National Standard for Wheel-
chairsVolume 1: Requirements and Test Methods for Wheel-
chairs (including Scooters) Section 26: Vocabulary.
Extent of recognition.
O. Radiology
1253 ................. 12257 ............. ISO 2919 Third edition 20120215 Radiological protection
Sealed radioactive sourcesGeneral requirements and classifica-
tion.
Withdrawn and replaced with
newer version.
1259 ................. ........................... IEC 61168 First edition 199312 Radiotherapy simulatorsFunc-
tional performance characteristics.
Extent of recognition.
1266 ................. ........................... AIUM MUS, Medical Ultrasound Safety ............................................... Extent of recognition.
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4930 Federal Register / Vol. 79, No. 20/ Thursday, January 30, 2014/ Notices
TABLE 1MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDSContinued
Old
recognition
No.
Replacement
recognition
No.
Title of standard
1
Change
12139 ............... ........................... AIUM AOMS2004, Acoustic Output Measurement Standard for Di-
agnostic Ultrasound Equipment.
Extent of recognition.
12140 ............... ........................... AIUM RTD22004 Standard for Real-Time Display of Thermal and
Mechanical Acoustic Output Indices on Diagnostic Ultrasound
Equipment Revision 2.
Withdrawn. See 12209 and 12
258.
12145 ............... 12259 ............. IEC 61674 Edition 2.0 201211 Medical electrical equipment
Dosimeters with ionization chambers and/or semiconductor detec-
tors as used in X-ray diagnostic imaging.
Withdrawn and replaced with
newer version.
12149 ............... 12260 ............. IEC 60336 Fourth edition 200504 Medical electrical equipment
X-ray tube assemblies for medical diagnosisCharacteristics of
focal spots [Including: Technical Corrigendum 1 (2006)].
Withdrawn and replaced with
newer version including tech-
nical corrigendum.
12150 ............... ........................... ISO/IEC 109181:1994 TECHNICAL CORRIGENDUM 1:2005 Infor-
mation technologyDigital compression and coding of continuous-
tone still imagePart 1: Requirements and guidelines.
Withdrawn. See 12261.
12156 ............... ........................... ISO 11670:2003 TECHNICAL CORRIGENDUM 1:2004 Lasers and
laser-related equipmentTest methods for laser beam param-
etersBeam positional stability.
Withdrawn. See 12262.
12157 ............... ........................... ISO 13694:2000 TECHNICAL CORRIGENDUM 1:2005 Optics and
optical instrumentsLasers and laser-related equipmentTest
methods for laser beam power (energy) density distribution.
Withdrawn. See 12263.
12159 ............... 12264 ............. NEMA MS 112010 Determination of Gradient-Induced Electric
Fields In Diagnostic Magnetic Resonance Imaging.
Withdrawn and replaced with
newer version.
12167 ............... 12265 ............. NEMA NU 22012 Performance Measurements of Positron Emis-
sion Tomographs (PETs).
Withdrawn and replaced with
newer version.
12179 ............... ........................... ANSI/IESNA RP27.32007, Recommended Practice for
Photobiological Safety for LampsRisk Group Classification and
Labeling.
Extent of recognition.
12180 ............... 12266 ............. IEC 61689 Edition 3.0 201302 Ultrasonic-Physiotherapy sys-
temsField specifications and methods of measurement in the
frequency range 0. 5 MHz to 5 MHz.
Withdrawn and replaced with
newer version.
12190 ............... 12267 ............. IEC 61217 Edition 2.0 201112 Radiotherapy equipmentCoordi-
nates, movements and scales.
Withdrawn and replaced with
newer version.
12194 ............... ........................... ANSI/HPS N43.62007, Sealed Radioactive SourcesClassification Extent of recognition.
12207 ............... 12271 ............. IEC 60601233 Edition 3.1 201304 Medical electrical equip-
mentPart 233: Particular requirements for the basic safety and
essential performance of magnetic resonance equipment for med-
ical diagnosis.
Withdrawn and replaced with
newer version.
12208 ............... 12268 ............. IEC 60601222 Edition 3.1 201210 Medical electrical equip-
mentPart 222: Particular requirements for basic safety and es-
sential performance of surgical, cosmetic, therapeutic and diag-
nostic laser equipment.
Withdrawn and replaced with
newer version.
12210 ............... 12269 ............. IEC 6060113 Edition 2.1 201304 Medical electrical equipment
Part 13: General requirements for basic safety and essential per-
formanceCollateral Standard: Radiation protection in diagnostic
X-ray equipment.
Withdrawn and replaced with
newer version.
12219 ............... ........................... IEC 60336 (2005) Medical electrical equipmentX-ray tube assem-
blies for medical diagnosisCharacteristics of focal spots.
Withdrawn. See 12260.
12222 ............... 12270 ............. IEC 6122335 First edition 200408 Evaluation and routine test-
ing in medical imaging departmentsPart 35: Acceptance tests
Imaging performance of computed tomography X-ray equipment
[Including: TECHNICAL CORRIGENDUM 1 (2006)].
Withdrawn and replaced with
newer version including tech-
nical corrigendum.
12223 ............... ........................... IEC 6122335 (First edition 2004) Evaluation and routine testing in
medical imaging departmentsPart 35: Acceptance testsImag-
ing performance of computed tomography X-ray equipment COR-
RIGENDUM 1.
Withdrawn. See 12270.
12227 ............... ........................... IEC 613911 First edition 200607 UltrasonicsPulse-echo scan-
nersPart 1: Techniques for calibrating spatial measurement sys-
tems and measurement of system point-spread function response.
Extent of recognition.
12228 ............... ........................... IEC 613912 Edition 1.0 201001 UltrasonicsPulse-echo scan-
nersPart 2: Measurement of maximum depth of penetration and
local dynamic range.
Extent of recognition.
12233 ............... 12262 ............. ISO 11670 Second edition 20030401 Lasers and laser-related
equipmentTest methods for laser beam parametersBeam po-
sitional stability [Including: TECHNICAL CORRIGENDUM 1 (2004)].
Withdrawn and replaced with
newer version including tech-
nical corrigendum.
12237 ............... 12258 ............. IEC 62359 Edition 2.0 201010 UltrasonicsField characteriza-
tionTest methods for the determination of thermal and mechan-
ical indices related to medical diagnostic ultrasonic fields [Including
TECHNICAL CORRIGENDUM 1 (2011)].
Withdrawn and replaced with
newer version including tech-
nical corrigendum.
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4931 Federal Register / Vol. 79, No. 20/ Thursday, January 30, 2014/ Notices
TABLE 1MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDSContinued
Old
recognition
No.
Replacement
recognition
No.
Title of standard
1
Change
12243 ............... 12263 ............. ISO 13694 First edition 20000401 Optics and optical instru-
mentsLasers and laser-related equipmentTest methods for
laser beam power [energy] density distribution [Including: TECH-
NICAL CORRIGENDUM 1 (2005)].
Withdrawn and replaced with
newer version including tech-
nical corrigendum.
12244 ............... ........................... IEC 62359 (Second edition 2010) March 2011 UltrasonicsField
characterizationTest methods for the determination of thermal
and mechanical indices related to medical diagnostic ultrasonic
fields CORRIGENDUM 1.
Withdrawn. See 12258.
12247 ............... ........................... ISO 119901 First edition 20110801, Lasers and laser-related
equipmentDetermination of laser resistance of tracheal tubes
Part 1: Tracheal tube shaft.
Extent of recognition.
P. Software/Informatics
134 ................... ........................... ANSI/UL 1998 Standards for Safety Software in Programmable
Components, Second Edition. [This Standard contains revisions
through and including October 28, 2008.]
Extent of recognition.
Q. Sterility
14143 ............... 14395 ............. ISO 146982 First edition 20030915 Cleanrooms and associated
controlled environmentsBiocontamination controlPart 2: Eval-
uation and interpretation of biocontamination data. [Including:
TECHNICAL CORRIGENDUM 1 Published 20041101].
Withdrawn and replaced with
newer version including tech-
nical corrigendum.
14193 ............... ........................... ANSI/AAMI/ISO 116071:2006/(R)2010 Packaging for terminally
sterilized medical devicesPart 1: Requirements for materials,
sterile barrier systems and packaging systems.
Extent of recognition and relevant
guidance.
14194 ............... ........................... ANSI/AAMI/ISO 116072:2006/(R)2010 Packaging for terminally
sterilized medical devicesPart 2: Validation requirements for
forming, sealing and assembly processes.
Extent of recognition and relevant
guidance.
14195 ............... ........................... ANSI/AAMI/ISO 111401:2005(R)2010 Sterilization of health care
productsChemical indicatorsPart 1: General requirements.
Extent of recognition.
14201 ............... 14396 ............. ANSI/AAMI ST77:2013 Containment devices for reusable medical
device sterilization.
Withdrawn and replaced with
newer version.
14214 ............... 14397 ............. AOAC 6.2.04:2013 Official Method 955.15 Testing Disinfectants
Against Staphylococcus aureus, Use-Dilution Method.
Withdrawn and replaced with
newer version.
14218 ............... 14398 ............. AOAC 6.3.05:2013 Official Method 966.04 Sporicidal Activity of Dis-
infectants Method I.
Withdrawn and replaced with
newer version.
14219 ............... 14399 ............. AOAC 6.3.06:2012 Official Method 965.12 Tuberculocidal Activity of
Disinfectants.
Withdrawn and replaced with
newer version.
14230 ............... 14400 ............. ASTM F220313 Standard Test Method for Linear Measurement
Using Precision Steel Rule.
Withdrawn and replaced with
newer version.
14231 ............... 14401 ............. ASTM F2217/F2217M13 Standard Practice for Coating/Adhesive
Weight Determination.
Withdrawn and replaced with
newer version.
14235 ............... 14402 ............. ASTM F1140/F1140M13 Standard Test Methods for Internal Pres-
surization Failure Resistance of Unrestrained Packages.
Withdrawn and replaced with
newer version.
14236 ............... 14403 ............. ASTM F2054/F2054M13 Standard Test Method for Burst Testing
of Flexible Package Seals Using Internal Air Pressurization Within
Restraining Plates.
Withdrawn and replaced with
newer version.
14241 ............... 14424 ............. ISO 134086 First edition 20050615 Aseptic processing of health
care productsPart 6: Isolator systems [Including AMENDMENT 1
(2013)].
Withdrawn and replaced with
newer version including amend-
ment.
14258 ............... 14404 ............. ASTM F225013 Standard Practice for Evaluation of Chemical Re-
sistance of Printed Inks and Coatings on Flexible Packaging Mate-
rials.
Withdrawn and replaced with
newer version.
14260 ............... 14405 ............. ASTM F2252/F2252M13
1
Standard Practice for Evaluating Ink or
Coating Adhesion to Flexible Packaging Materials Using Tape.
Withdrawn and replaced with
newer version.
14264 ............... 14406 ............. ANSI/AAMI ST8:2013 Hospital steam sterilizers ............................... Withdrawn and replaced with
newer version.
14274 ............... ........................... ANSI/AAMI/ISO 15882:2008 Sterilization of health care products
Chemical indicatorsGuidance for selection, use, and interpreta-
tion of results.
Extent of recognition and relevant
guidance.
14285 ............... ........................... ANSI/AAMI/ISO 14161:2009 Sterilization of health care products
Biological indicatorsGuidance for the selection, use and interpre-
tation of results.
Extent of recognition.
14289 ............... ........................... ISO 146982:2003 TECHNICAL CORRIGENDUM Cleanrooms and
associated controlled environmentsBiocontamination control
Part 2: Evaluation and interpretation of biocontamination data.
Withdrawn. See 14395.
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4932 Federal Register / Vol. 79, No. 20/ Thursday, January 30, 2014/ Notices
TABLE 1MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDSContinued
Old
recognition
No.
Replacement
recognition
No.
Title of standard
1
Change
14296 ............... ........................... ANSI/AAMI/ISO 111381:2006/(R)2010, Sterilization of health care
productsBiological indicatorsPart 1: General requirements.
Relevant guidance.
14300 ............... ........................... ASTM D416909 Standard Practice for Performance Testing of
Shipping Containers and Systems.
Extent of recognition.
14326 ............... 14407 ............. ISO 117371 Second edition 20060401, Sterilization of medical
devicesMicrobiological methodsPart 1: Determination of a
population of microorganisms on products [Including: TECHNICAL
CORRIGENDUM 1 Published 20070515].
Withdrawn and replaced with
newer version including tech-
nical corrigendum.
14328 ............... 14428 ............. ISO 111371 First edition 20060415 Sterilization of health care
productsRadiationPart 1: Requirements for development, vali-
dation and routine control of a sterilization process for medical de-
vices [Including AMENDMENT 1 (2013)].
Withdrawn and replaced with
newer version including amend-
ment.
14334 ............... ........................... ISO 15882 Second edition 20080901 Sterilization of health care
productsChemical indicatorsGuidance for selection, use and
interpretation of results.
Extent of recognition, title.
14335 ............... 14408 ............. ISO 109937 Second edition 20081015 Biological evaluation of
medical devicesPart 7: Ethylene oxide sterilization residuals [In-
cluding: TECHNICAL CORRIGENDUM 1 Published 20091115].
Withdrawn and replaced with
newer version including tech-
nical corrigendum.
14336 ............... ........................... ISO 14161 Second edition 20090915 Sterilization of health care
productsBiological indicatorsGuidance for the selection, use
and interpretation of results.
Extent of recognition.
14338 ............... ........................... ISO 111381 Second edition 20060701, Sterilization of health
care productsBiological indicatorsPart 1: General requirements.
Relevant guidance.
14352 ............... 14425 ............. ANSI/AAMI/ISO 134086:2005 Aseptic processing of health care
productsPart 6: Isolator systems [Including AMENDMENT 1
(2013)].
Withdrawn and replaced with
newer version including amend-
ment.
14353 ............... ........................... ISO 111401 Second edition 20050715 Sterilization of health
care productsChemical indicatorsPart 1: General requirements.
Extent of recognition.
14355 ............... ........................... ISO 116071 First edition 20060415 Packaging for terminally
sterilized medical devicesPart 1: Requirements for materials,
sterile barrier systems and packaging systems.
Extent of recognition and relevant
guidance.
14356 ............... ........................... ISO 116072 First edition 20060415 Packaging for terminally
sterilized medical devicesPart 2: Validation requirements for
forming, sealing and assembly processes.
Extent of recognition.
14357 ............... ........................... ISO 117371:2006 TECHNICAL CORRIGENDUM 1 Published
20070515 Sterilization of medical devicesMicrobiological
methodsPart 1: Determination of a population of microorganisms
on products.
Withdrawn. See 14407.
14360 ............... ........................... ANSI/AAMI ST72:2011, Bacterial endotoxinsTest methods, routine
monitoring, and alternatives to batch testing.
Relevant guidance.
14362 ............... 14412 ............. AOAC 6.2.01:2013 Official Method 955.14, Testing Disinfectants
Against Salmonella choleraesuis, Use-Dilution Method.
Withdrawn and replaced with
newer version.
14363 ............... 14413 ............. AOAC 6.2.06:2013 Official Method 964.02, Testing Disinfectants
Against Pseudomonas aeruginosa, Use-Dilution Method.
Withdrawn and replaced with
newer version.
14365 ............... 14409 ............. ISO 111372 Third edition 20130601 Sterilization of health care
productsRadiationPart 2: Establishing the sterilization dose.
Withdrawn and replaced with
newer version.
14366 ............... 14414 ............. USP 36NF31:2013 <61> Microbiological Examination of Nonsterile
Products: Microbial Enumeration Tests.
Withdrawn and replaced with
newer version.
14367 ............... 14415 ............. USP 36NF31:2013 <71> Sterility Tests ............................................. Withdrawn and replaced with
newer version.
14368 ............... 14416 ............. USP 36NF31:2013 <85> Bacterial Endotoxins Test .......................... Withdrawn and replaced with
newer version.
14369 ............... 14417 ............. USP 36NF31:2013 <151> Pyrogen Test (USP Rabbit Test) ............. Withdrawn and replaced with
newer version.
14370 ............... 14418 ............. USP 36NF31:2013 <161> Transfusion and Infusion Assemblies and
Similar Medical Devices.
Withdrawn and replaced with
newer version.
14371 ............... 14419 ............. USP 36NF31:2013 Biological Indicator for Steam Sterilization,
Self-Contained.
Withdrawn and replaced with
newer version.
14372 ............... 14420 ............. USP 36NF31:2013 Biological Indicator for Dry-Heat Sterilization,
Paper Carrier.
Withdrawn and replaced with
newer version.
14373 ............... 14421 ............. USP 36NF31:2013 Biological Indicator for Ethylene Oxide Steri-
lization, Paper Carrier.
Withdrawn and replaced with
newer version.
14374 ............... 14422 ............. USP 36NF31:2013 Biological Indicator for Steam Sterilization,
Paper Carrier.
Withdrawn and replaced with
newer version.
14375 ............... 14423 ............. USP 36NF31:2013 <62> Microbiological Examination of Nonsterile
Products: Tests for Specified Microorganisms.
Withdrawn and replaced with
newer version.
14380 ............... 14410 ............. ASTM F1713 Standard Terminology Relating to Flexible Barrier
Packaging.
Withdrawn and replaced with
newer version.
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4933 Federal Register / Vol. 79, No. 20/ Thursday, January 30, 2014/ Notices
TABLE 1MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDSContinued
Old
recognition
No.
Replacement
recognition
No.
Title of standard
1
Change
14384 ............... ........................... ISO 109937:2008 TECHNICAL CORRIGENDUM 1, Published
20091115 Biological evaluation of medical devicesPart 7:
Ethylene oxide sterilization residuals.
Withdrawn. See 14408.
14385 ............... 14426 ............. ANSI/AAMI/ISO 134081:2008 (R2011) Aseptic processing of
health care productsPart 1: General requirements [Including
AMENDMENT 1 (2013)].
Withdrawn and replaced with
newer version including amend-
ment.
14386 ............... 14427 ............. ISO 134081 Second edition 20080615 Aseptic processing of
health care productsPart 1: General requirements [Including
AMENDMENT 1 (2013)].
Withdrawn and replaced with
newer version including amend-
ment.
14393 ............... 14411 ............. ISO/ASTM 51818 Third edition 20130601 Practice for dosimetry
in an electron beam facility for radiation processing at energies be-
tween 80 and 300 keV.
Withdrawn and replaced with
newer version.
1
All standard titles in this table conform to the style requirements of the respective organizations.
III. Listing of New Entries
In table 2 of this document, FDA
provides the listing of new entries and
consensus standards added as
modifications to the list of recognized
standards under Recognition List
Number: 034.
TABLE 2.NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS
Recognition No. Title of standard
1
Reference No. and date
A. Anesthesia
196 ................... Medical electrical equipmentPart 255: Particular requirements for the basic
safety and essential performance of respiratory gas monitors.
ISO 80601255 First edition 201112
15.
B. Cardiovascular
3121 ................. Cardiovascular implantsEndovascular devicesPart 1: Endovascular pros-
theses [Including: Amendment 1 (2005)].
ISO 255391 First edition 20030301.
C. General
583 ................... MEDICAL ELECTRICAL EQUIPMENTPart 111: General requirements for
basic safety and essential performanceCollateral Standard: Requirements for
medical electrical equipment and medical electrical systems used in the home
healthcare environment (IEC 60601111:2010, MOD).
ANSI/AAMI HA6060111:2011.
584 ................... Design of training and instructional materials for medical devices used in non-clin-
ical environments.
AAMI TIR49:2013.
585 ................... Medical electrical equipmentPart 16: General requirements for basic safety
and essential performanceCollateral standard: Usability.
IEC 6060116 Edition 3.0 201001.
586 ................... Medical electrical equipmentPart 18: General requirements for basic safety
and essential performanceCollateral Standard: General requirements, tests
and guidance for alarm systems in medical electrical equipment and medical
electrical systems.
IEC 6060118 Edition 2.0 200610.
D. General Hospital/General Plastic Surgery
6302 ................. Stainless steel needle tubing for the manufacture of medical devices [Including:
AMENDMENT 1 20010601].
ISO 9626 First edition 19910901.
6318 ................. Infusion equipment for medical usePart 4: Infusion sets for single use, gravity
feed [Including: AMENDMENT 1 20130301].
ISO 85364 Fifth edition 20101001.
6320 ................. Medical electrical equipmentPart 220: Particular requirements for the basic
safety and essential performance of infant transport incubators [Including:
CORRIGENDUM 1 (February 2012) and CORRIGENDUM 2 (February 2013)].
IEC 60601220 Edition 2.0 200902.
6321 ................. Medical electrical equipmentPart 252: Particular requirements for basic safety
and essential performance of medical beds [Including: CORRIGENDUM 1
(September 2010)].
IEC 60601252 Edition 1.0 200912.
6322 ................. Intravascular cathetersSterile and single-use cathetersPart 4: Balloon dilata-
tion catheters.
ISO 105554 Second edition 201306
15.
E. Material
8358 ................. Standard Specification for Polyoxymethylene (Acetal) for Medical Applications ...... ASTM F185500 (Reapproved 2011).
8359 ................. Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Appli-
cations Part IFormulations and Uncured Materials.
ASTM F203800 (Reapproved 2011).
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4934 Federal Register / Vol. 79, No. 20/ Thursday, January 30, 2014/ Notices
TABLE 2.NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDSContinued
Recognition No. Title of standard
1
Reference No. and date
8360 ................. Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Appli-
cations Part IICross-Linking and Fabrication.
ASTM F204200 (Reapproved 2011).
8361 ................. Standard Specification for Selection of Porous Polyethylene for Use in Surgical
Implants.
ASTM F75599 (Reapproved 2011).
8362 ................. Standard Specification for Metal Injection Molded Unalloyed Titanium Compo-
nents for Surgical Implant Applications.
ASTM F298913.
8363 ................. Standard Test Method for Tensile Properties of Plastics ......................................... ASTM D63810.
8364 ................. Standard Test Methods for Density and Specific Gravity (Relative Density) of
Plastics by Displacement.
ASTM D79208.
8365 ................. Standard Test Method for Density of Plastics by the Density-Gradient Technique ASTM D150510.
8366 ................. Ultra-high-molecular-weight polyethylene (PEUHMW) moulding and extrusion
materialsPart 2: Preparation of test specimens and determination of prop-
erties.
ISO 115422 First edition 19981115.
8367 ................. Standard Test Method for Measurement of Fatigue Crack Growth Rates ............... ASTM E64713
1
.
8368 ................. Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystal-
linity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means
of Differential Scanning Calorimetry.
ASTM F262510.
8369 ................. Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Poly-
ethylene after Gamma Irradiation in Air.
ASTM F200302 (Reapproved 2008).
F. OBGYN/Gastroenterology/Urology
986 ................... Rubber condoms for clinical trialsMeasurement of physical properties Including
[AMENDMENT 1 20110215)].
ISO 16037 First Edition 20020515.
987 ................... Female condomsRequirements and test methods ................................................ ISO 25841 First Edition 20110715.
988 ................... Prophylactic damsRequirements and test methods .............................................. ISO 29942 First Edition 20110701.
989 ................... Cardiovascular implants and extracorporeal blood circuit for haemodialysers,
haemodiafilters, and haemofilters.
ISO 8638 Third edition 20100701.
992 ................... Cardiovascular implants and extracorporeal systemsHaemodialysers,
haemodiafilters, haemofilters and haemoconcentrators Including [AMENDMENT
1 20130401)].
ISO 8637 Third edition 20100701.
G. Ophthalmics
1087 ................. Standard Test Method for Tensile Properties of Thin Plastic Sheeting ................... ASTM D88212.
1088 ................. Standard Test Methods for Flexural Properties of Unreinforced and Reinforced
Plastics and Electrical Insulating Materials.
ASTM D79010.
H. Orthopedics
11259 ............... Standard Specification For Total Elbow Prostheses ................................................. ASTM F288712.
11260 ............... Standard Guide for Presentation of End User Labeling Information for Orthopedic
Implants Used in Joint Arthroplasty.
ASTM F294313.
11261 ............... Standard Specification for Shoulder Prostheses ...................................................... ASTM F137812
11262 ............... Standard Specification for Acetabular Prostheses .................................................... ASTM F209101 (Reapproved 2012).
11263 ............... Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disasso-
ciation.
ASTM F202808 (Reapproved 2012)
1
.
11264 ............... Standard Test Method for Determining the Forces for Disassembly of Modular
Acetabular Devices.
ASTM F182013.
11265 ............... Standard Practice for Evaluation of Modular Connection of Proximally Fixed Fem-
oral Hip Prosthesis.
ASTM F258013.
11266 ............... Standard Specification for Total Ankle Replacement Prosthesis ............................. ASTM F266509.
11267 ............... Standard Test Method for Determining the Axial Disassembly Force of Taper
Connections of Modular Prostheses.
ASTM F200900 (Reapproved 2011).
11268 ............... Standard Test Method for Static Evaluation of Glenoid Locking Mechanism in
Shear.
ASTM F182998 (Reapproved 2009).
11269 ............... Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc
Prostheses.
ASTM F242311.
11270 ............... Standard Specification and Test Methods for Absorbable Plates and Screws for
Internal Fixation Implants.
ASTM F250211.
11271 ............... Standard Specification for Metallic Implantable Strands and Cables ....................... ASTM F218002 (Reapproved 2011).
11272 ............... Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in
Simulator Devices.
ASTM F171496 (Reapproved 2013).
11273 ............... Implants for surgeryWear of total intervertebral spinal disc prosthesesPart 1
Loading and displacement parameters for wear testing and corresponding envi-
ronmental conditions for test.
ISO 181921 Second edition 201103
01.
11274 ............... Implants for surgeryWear of total intervertebral spinal disc prosthesesPart 2:
Nucleus replacements.
ISO 181922 First edition 20100615.
11275 ............... Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High
Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Im-
plants by Infrared Spectroscopy.
ASTM F238110.
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4935 Federal Register / Vol. 79, No. 20/ Thursday, January 30, 2014/ Notices
TABLE 2.NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDSContinued
Recognition No. Title of standard
1
Reference No. and date
I. Radiology
12261 ............... Information technologyDigital compression and coding of continuous-tone still
images: Requirements and guidelines [Including: TECHNICAL CORRIGENDUM
1 (2005)].
ISO/IEC 109181 First edition 199402
15.
J. Software/Informatics
1363 ................. Application of risk management for IT-networks incorporating medical devices
Part 24: Application guidanceGeneral implementation guidance for
healthcare delivery organizations.
IEC/TR 8000124 Edition 1.0 201211.
1364 ................. Application of risk management for IT-networks incorporating medical devices
Part 24: General implementation guidance for healthcare delivery organiza-
tions.
ANSI/AAMI/IEC TIR8000124:2012.
K. Sterility
14429 ............... Practice for use of a radiochromic film dosimetry system ........................................ ISO/ASTM 51275 Third edition 2013
0601.
14430 ............... Practice for use of an alanine-EPR dosimetry system ............................................. ISO/ASTM 51607 Third edition 2013
0601.
14431 ............... Guide for estimating uncertainties in dosimetry for radiation processing ................. ISO/ASTM 51707 Second edition 2005
0515.
1
All standard titles in this table conform to the style requirements of the respective organizations.
IV. List of Recognized Standards
FDA maintains the Agencys current
list of FDA recognized consensus
standards in a searchable database that
may be accessed directly at FDAs
Internet site at http://www.accessdata.
fda.gov/scripts/cdrh/cfdocs/
cfStandards/search.cfm. FDA will
incorporate the modifications and
revisions described in this notice into
the database and, upon publication in
the Federal Register, this recognition of
consensus standards will be effective.
FDA will announce additional
modifications and revisions to the list of
recognized consensus standards, as
needed, in the Federal Register once a
year, or more often, if necessary.
Beginning with recognition list 033,
FDA no longer announces minor
revisions to the list of recognized
consensus standards such as technical
contact person, relevant guidance,
processes affected, CFR citations, and
product codes.
V. Recommendation of Standards for
Recognition by FDA
Any person may recommend
consensus standards as candidates for
recognition under section 514 of the
FD&C Act by submitting such
recommendations, with reasons for the
recommendation, to the contact person
(see FOR FURTHER INFORMATION CONTACT).
To be properly considered, such
recommendations should contain, at a
minimum, the following information:
(1) The title of the standard, (2) any
reference number and date, (3) the name
and address of the national or
international standards development
organization, (4) a proposed list of
devices for which a declaration of
conformity to this standard should
routinely apply, and (5) a brief
identification of the testing or
performance or other characteristics of
the device(s) that would be addressed
by a declaration of conformity.
VI. Electronic Access
You may obtain a copy of Guidance
on the Recognition and Use of
Consensus Standards by using the
Internet. The Center for Devices and
Radiological Health (CDRH) maintains a
site on the Internet for easy access to
information including text, graphics,
and files that you may download to a
personal computer with access to the
Internet. Updated on a regular basis, the
CDRH home page includes the guidance
as well as the current list of recognized
standards and other standards-related
documents. After publication in the
Federal Register, this notice
announcing Modification to the List of
Recognized Standards, Recognition List
Number: 034 will be available on the
CDRH home page. You may access the
CDRH home page at http://www.fda.gov/
MedicalDevices.
You may access Guidance on the
Recognition and Use of Consensus
Standards, and the searchable database
for FDA Recognized Consensus
Standards at http://www.fda.gov/
MedicalDevices/DeviceRegulationand
Guidance/Standards.
This Federal Register document on
modifications in FDAs recognition of
consensus standards is available at
http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123792.htm.
VII. Submission of Comments and
Effective Date
Interested persons may submit to the
contact person (see FOR FURTHER
INFORMATION CONTACT) either electronic
or written comments regarding this
document. It is only necessary to send
one set of comments. Comments are to
be identified with the docket number
found in brackets in the heading of this
document. FDA will consider any
comments received in determining
whether to amend the current listing of
modifications to the list of recognized
standards, Recognition List Number:
034. These modifications to the list of
recognized standards are effective upon
publication of this notice in the Federal
Register.
Dated: January 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 201401847 Filed 12914; 8:45 am]
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