Designation: F90 − 14

Standard Specification for

Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for
Surgical Implant Applications (UNS R30605)1
This standard is issued under the fixed designation F90; the number immediately following the designation indicates the year of original
adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript
epsilon (´) indicates an editorial change since the last revision or reapproval.

1. Scope* F2527 Specification for Wrought Seamless and Welded and

1.1 This specification covers the requirements for wrought Drawn Cobalt Alloy Small Diameter Tubing for Surgical
cobalt-20chromium-15tungsten-10nickel alloy used for surgi- Implants (UNS R30003, UNS R30008, UNS R30035,
cal implants. The properties specified apply specifically to UNS R30605, and UNS R31537)
wrought bar, rod, wire, sheet, and strip, but do not apply to IEEE/ASTM SI 10 American National Standard for Use of
surgical fixation wire (see Specification F1091). the International System of Units (SI): The Modern Metric
System
1.2 The SI units in this standard are the primary units. 2.2 Aerospace Material Specification:3
Values in primary SI or secondary inch-pound units are to be AMS 2269 Chemical Check Analysis Limits, Wrought
regarded separately as standard. The values stated in each Nickel Alloys and Cobalt Alloys
system may not be exact equivalents; therefore each system AMS 5759 Cobalt Alloy, Corrosion and Heat Resistant Bars,
shall be used independent of the other. Combining values from Forgings, and Rings, 52Co – 20 Cr – 10Ni – 15W,
the two systems may result in non-conformance with the Solution Heat Treated
specification.
2.3 ISO Standards:4
2. Referenced Documents ISO 5832-5 Wrought Cobalt-Chromium-Tungsten-Nickel
Alloy
2.1 ASTM Standards:2
ISO 6892 Metallic Materials Tensile Testing at Ambient
A751 Test Methods, Practices, and Terminology for Chemi-
Temperature
cal Analysis of Steel Products
ISO 9001 Quality System—Requirements
E8/E8M Test Methods for Tension Testing of Metallic Ma-
terials 2.4 American Society for Quality (ASQ) Standard:
E29 Practice for Using Significant Digits in Test Data to C1 Specification of General Requirements for a Quality
Determine Conformance with Specifications Program5
E45 Test Methods for Determining the Inclusion Content of
3. Classification
Steel
E354 Test Methods for Chemical Analysis of High- 3.1 Bar—Round, rectangular, or other complex shaped
Temperature, Electrical, Magnetic, and Other Similar Iron, product delivered straightened and cut to defined lengths, with
Nickel, and Cobalt Alloys a maximum cross-sectional area of 16 in.2 (103 cm2).
F981 Practice for Assessment of Compatibility of Biomate- 3.2 Wire—Round, rectangular, or other complex shaped
rials for Surgical Implants with Respect to Effect of product produced and delivered in coils.
Materials on Muscle and Bone
3.3 Fine Wire—Wire with diameter or major dimension less
F1091 Specification for Wrought Cobalt-20Chromium-
than 0.063 in. (1.6 mm).
15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS
R30605) 4. Ordering Information
1
4.1 Inquiries and orders for material under this specification
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
shall include the following information:
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Nov. 1, 2014. Published January 2015. Originally
3
approved in 1968. Last previous edition approved in 2009 as F90 – 09. DOI: Available from Society of Automotive Engineers (SAE), 400 Commonwealth
10.1520/F0090-14. Dr., Warrendale, PA 15096-0001, http://www.sae.org.
2 4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM 4th Floor, New York, NY 10036, http://www.ansi.org.
5
Standards volume information, refer to the standard’s Document Summary page on Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
the ASTM website. Milwaukee, WI 53203, http://www.asq.org.

*A Summary of Changes section appears at the end of this standard

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 F90 − 14
4.1.1 Quantity, TABLE 2 Product Analysis TolerancesA
4.1.2 ASTM designation and date of issue, Element
Tolerance Under the Minimum Limit or Over the
Maximum LimitB
4.1.3 Mechanical properties (see Section 7),
Carbon 0.01
4.1.4 Form (bar, rod, wire, sheet, strip), Manganese 0.04
4.1.5 Applicable dimensions including size, thickness, Silicon 0.03
width, and length (exact, random, or multiples) or drawing Phosphorous 0.005
Sulfur 0.005
number, Chromium 0.25
4.1.6 Condition (see 5.1), Nickel 0.15 under min; 0.20 over max
4.1.7 Finish (see 5.2), Tungsten 0.25
Iron 0.07
4.1.8 Other requirements.
A
Refer to AMS 2269.
B
Under minimum limit not applicable for elements where only a maximum
5. Materials and Manufacture percentage is indicated.
5.1 Condition—Bar, wire, sheet, and strip shall be furnished
to the purchaser, as specified, in the annealed cold-worked, or
cold worked and aged condition. 6.4 Methods and practices relating to chemical analysis
5.2 Finish: required by this specification shall be in accordance with Test
5.2.1 Bar and wire shall be furnished bright annealed, cold Methods A751.
drawn, pickled, ground, or ground and polished, as specified by 7. Mechanical Requirements
the purchaser.
5.2.2 Sheet shall be furnished bright annealed, pickled, 7.1 The material in the annealed condition shall conform to
cold-rolled, or polished, as specified by the purchaser. the mechanical properties specified in Tables 3 and 4.
7.2 Material in the cold worked condition shall conform to
6. Chemical Requirements the mechanical properties specified in Table 3.
6.1 The heat analysis shall conform to the chemical com- 7.3 The cold worked and aged condition may be ordered in
position of Table 1. The supplier shall not ship material that is accordance with mechanical property requirements agreed
outside the limits specified in Table 1. upon between supplier and purchaser.
6.1.1 Requirements for the major and minor elemental
7.4 Tensile properties shall be determined in accordance
constituents are listed in Table 1. Also listed are important
with Test Methods E8/E8M. Perform at least one tension test
residual elements. Analysis for elements not listed in Table 1 is
from each lot. Should any test piece not meet the specified
not required to verify compliance with this specification.
requirements, test two additional test pieces representative of
6.2 Product Analysis—The product analysis is either for the the same lot, in the same manner, for each failed test piece. The
purpose of verifying the composition of a heat or lot or to lot shall be considered in compliance only if all additional test
determine variations in the composition within the heat. pieces meet the specified requirements.
6.2.1 Acceptance or rejection of a heat or lot of material 7.4.1 Tensile tests results for which any specimen fractures
may be made by the purchaser on the basis of this product outside the gauge length shall be considered acceptable if the
analysis. elongation meets the minimum requirement specified. Refer to
6.2.2 Product analysis tolerances do not broaden the speci- 7.11.4 of Test Methods E8/E8M. If the elongation is less than
fied heat analysis requirements but instead cover variations the minimum requirement, discard the test and retest. Retest
between laboratories in the measurement of chemical content. one specimen for each specimen that did not meet the
Product analysis limits shall be as specified in Table 2. minimum requirements.
6.3 For referee purposes, Test Methods E354 shall be used.
8. Metallurgical Requirements
8.1 The microcleanliness of the alloy as determined by
TABLE 1 Chemical Requirements Method A of Test Methods E45, except using Plate I-r, on
Composition, % (mass/mass)
representative billet or bar samples from the heat shall not
Element
min max
exceed the limits of Table 5.
Carbon 0.05 0.15
Manganese 1.00 2.00
9. Units of Measure
Silicon ... 0.40 9.1 Selection—This specification requires that the purchaser
Phosphorus ... 0.040
Sulfur ... 0.030 selects the units (SI or inch-pound) to be used for product
Chromium 19.00 21.00 certification.
Nickel 9.00 11.00
Tungsten 14.00 16.00 9.2 Conversion of Units—If the supplier’s test equipment
Iron ... 3.00 does not normally report in the selected units, the test equip-
CobaltA balance balance
ment units may be converted to the selected units for certifi-
A
Approximately equal to the difference between 100 % and the sum percentage cation purposes. Accurate arithmetic conversion and proper use
of the other specified elements. The percentage of the cobalt difference is not
required to be reported. of significant digits should be observed when performing this
conversion. IEEE/ASTM SI 10 provides guidelines for the use

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 F90 − 14
TABLE 3 Mechanical Requirements, Bar and WireA
Condition
Ultimate Tensile Strength, Yield Strength (0.2 % Offset), ElongationB ,C in 4D or 4W,
MPa (psi), min MPa (psi), min min, %
Annealed 860 (125 000) 310 (45 000) 30
Cold-workedD 1250 (180 000) 760 (110 000) 15
A
Annealed wire less than 0.063 in. (160 mm) diameter is covered in Specification F1091.
B
4D = 4 × diameter; 4W = 4 × width.
C
Elongation of material 0.062 in. (1.575 mm) or greater in diameter (D) or width (W ) shall be measured using a gauge length of 2 in. or 4D or 4W. The gauge length shall
be reported with the test results. The method for determining elongation of material under 0.062 in. (1.575 mm) in diameter or thickness may be negotiated. Alternately,
a gauge length corresponding to ISO 6892 may be used when agreed upon between supplier and purchaser; 5.65 times the square root of So, where So is the original
cross-sectional area).
D
Cold worked and aged condition may be ordered in accordance with mechanical requirements agreed upon between supplier and purchaser.

TABLE 4 Mechanical Requirements, Sheet and Strip

Ultimate Tensile Strength, Yield Strength (0.2 % Offset), Elongation in 2 in.
Condition Thickness, in. (mm)
MPa (psi), min MPa (psi), min (50 mm), min, %
Annealed 0.010 to 0.020 (0.254 to 0.508), incl 896 (130 000) 379 (55 000) 30
over 0.020 to 0.032 (0.508 to 0.813), incl 896 (130 000) 379 (55 000) 35
over 0.032 to 0.043 (0.813 to 1.09), incl 896 (130 000) 379 (55 000) 40
over 0.043 to 0.187 (1.09 to 4.75), incl 896 (130 000) 379 (55 000) 45

TABLE 5 Microcleanliness Requirements unit in the last right-hand digit used in expressing the specifi-
Inclusion A B C
D cation limit, in accordance with the rounding method of
(Globular Practice E29.
Type (Sulfide) (Alumina) (Silicate)
Oxides)
Thin 1.5 1.5 1.5 1.5 11. Certification
Heavy 1.0 1.0 1.0 1.0
11.1 The supplier shall provide a certification that the
material was tested in accordance with this specification and
met all requirements. A report of the test results shall be
furnished to the purchaser at the time of shipment.
of SI units. Annex A of IEEE/ASTM SI 10 provides conversion
tables and Annex B of IEEE/ASTM SI 10 provides rules for 12. Quality Program Requirements
conversion and significant digits. 12.1 The supplier shall maintain a quality program, such as
defined in ISO 9001, or similar.
10. Significance of Numerical Limits
10.1 The following applies to all specified numerical limits 13. Keywords
in this specification. To determine conformance to these limits, 13.1 cobalt alloys (for surgical implants); cobalt chromium;
an observed or calculated value shall be rounded to the nearest L-605 alloy; metals (for surgical implants)—cobalt alloys

APPENDIXES

(Nonmandatory Information)

X1. RATIONALE

X1.1 The primary reason for this specification is to charac- X1.3 ISO standards are listed for reference only. Use of an
terize composition and properties to ensure consistency in the ISO standard, in addition to, or instead of a preferred ASTM
starting material used, directly or as modified by forging, standard may be negotiated between the purchaser and sup-
casting, or shape forming, in the manufacturing of medical plier.
devices.
X1.4 This cobalt base alloy, UNS R30605, is known generi-
X1.2 The minimum mechanical properties for sheet and cally as “L-605” and has been used extensively in the aero-
strip supplied in the annealed condition are generally recog- space industry since the early 1980s. Aerospace Material
nized as commercially attainable for the thickness range cited Specification AMS 5759 includes the chemical and mechanical
in this specification. properties for the UNS 30605, Cobalt Alloy, Corrosion and

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 F90 − 14
Heat Resistant, Bars, Forgings, and Rings, 52Co - 20Cr - 10Ni and 2018. In the first phase of this transition, running to 2013,
15W, Solution Heat-Treated. ISO standard 5832-5 for Wrought the specifications will be structured to allow the use of either SI
Cobalt-Chromium-Tungsten-Nickel Alloy also describes co- or inch - pound units. The choice of primary units in each
balt base alloy UNS R30605. specification will be determined by the industry using the
specification. The change to SI units during this period may be
X1.5 Units of Measure initiated by the purchaser through his purchase documentation.
X1.5.1 ASTM Policy—ASTM is promoting the use of ratio- In the second phase of this transition the specifications will be
nalized SI (metric) units in their standards. The F12.04 written with SI as the primary units. Harmonization with
Committee has modified this specification to facilitate the corresponding ISO documents will be considered when assign-
transition by the medical materials industry to SI between now ing the SI values.

X2. BIOCOMPATIBILITY

X2.1 The material composition covered by this standard has X2.2 No known surgical implant material has ever been
been employed successfully in human implant applications in shown to be completely free of adverse reactions in the human
contact with soft tissue and bone for over a decade. Due to the body. However, long term clinical experience has shown an
well characterized level of local biological response estab- acceptable level of biological response can be expected, if the
lished by this material, it has been used as a control material in material is used in appropriate applications.
Practice F981.

SUMMARY OF CHANGES

Committee F04 has identified the location of selected changes to this standard since the last issue (F90 – 09)
that may impact the use of this standard. (Approved Nov. 1, 2015)

(1) Editorial corrections have been made in order to meet (4) Cold worked and aged condition was added to 5.1, Table 3,
terminology and formatting guidelines established for implant and new 7.3.
material standards within F04.12. (5) Units of measure information was added as new Section 9.
(2) Section 1.2 was changed to make SI units the primary and new X1.5.
units.
(3) Designation for Test Methods E8 was corrected to Test
Methods E8/E8M.

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