This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles

for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Designation: F1635 − 11

Standard Test Method for

in vitro Degradation Testing of Hydrolytically Degradable
Polymer Resins and Fabricated Forms for Surgical
Implants1
This standard is issued under the fixed designation F1635; 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 Scope Constant-Amplitude-of-Force (Withdrawn 2002)3

1.1 This test method covers in vitro degradation of hydro- D695 Test Method for Compressive Properties of Rigid
lytically degradable polymers (HDP) intended for use in Plastics
surgical implants. D747 Test Method for Apparent Bending Modulus of Plas-
tics by Means of a Cantilever Beam
1.2 The requirements of this test method apply to HDPs in D790 Test Methods for Flexural Properties of Unreinforced
various forms: and Reinforced Plastics and Electrical Insulating Materi-
1.2.1 Virgin polymer resins, or als
1.2.2 Any form fabricated from virgin polymer such as a D882 Test Method for Tensile Properties of Thin Plastic
semi-finished component of a finished product, a finished Sheeting
product, which may include packaged and sterilized implants, D1708 Test Method for Tensile Properties of Plastics by Use
or a specially fabricated test specimen. of Microtensile Specimens
1.3 This test method provides guidance for mechanical D1822 Test Method for Tensile-Impact Energy to Break
loading or fluid flow, or both, when relevant to the device being Plastics and Electrical Insulating Materials
evaluated. The specifics of loading type, magnitude, and D2857 Practice for Dilute Solution Viscosity of Polymers
frequency for a given application are beyond the scope of this F748 Practice for Selecting Generic Biological Test Methods
test method. for Materials and Devices
1.4 The values stated in SI units are to be regarded as 2.2 Other Referenced Standard:
standard. No other units of measurement are included in this ISO 31–8 Physical Chemistry and Molecular Physics - Part
standard. 8: Quantities and Units
ISO 10993–1 Biological Evaluation of Medical Devices—
1.5 This standard does not purport to address all of the Part 1 Evaluation and Testing4
safety concerns, if any, associated with its use. It is the ISO 10993–9 Biological Evaluation of Medical Devices—
responsibility of the user of this standard to establish appro- Part 9 Framework for Identification and Quantification of
priate safety and health practices and determine the applica- Potential Degradation Products4
bility of regulatory limitations prior to use. NIST Special Publication SP811 Guide for the Use of the
International System of Units (SI)5
2. Referenced Documents
2.1 ASTM Standards:2 3. Terminology
D638 Test Method for Tensile Properties of Plastics 3.1 Definitions:
D671 Test Method for Flexural Fatigue of Plastics by 3.1.1 absorbable, adj—in the body—an initially distinct
foreign material or substance that either directly or through
intended degradation can pass through or be assimilated by
1
This test method is under the jurisdiction of ASTM Committee F04 on Medical cells and/or tissue.
and Surgical Materials and Devicesand is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
3
Current edition approved March 1, 2011. Published March 2011. Originally The last approved version of this historical standard is referenced on
approved in 1995. Last previous edition approved in 2004 as F1635 – 04a. DOI: www.astm.org.
4
10.1520/F1635-11. Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 4th Floor, New York, NY 10036, http://www.ansi.org.
5
contact ASTM Customer Service at [email protected]. For Annual Book of ASTM Available from National Institute of Standards and Technology (NIST), 100
Standards volume information, refer to the standard’s Document Summary page on Bureau Dr., Stop 1070, Gaithersburg, MD 20899-1070, at http://physics.nist.gov/
the ASTM website. cuu/Units/bibliography.html.

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 F1635 − 11
NOTE 1—See Appendix X2 for a discussion regarding the usage of unchallenged hydrolytic conditions at 37°C in buffered saline
absorbable and other related terms. is a common means to obtain a first approximation of the
3.1.2 hydrolytically degradable polymer (HDP)—any poly- degradation profile of an absorbable material or device. It does
meric material in which the primary mechanism of chemical not necessarily represent actual in vivo service conditions,
degradation in the body is by hydrolysis (water reacting with which can include mechanical loading in a variety of forms (for
the polymer resulting in cleavage of the chain). example. static tensile, cyclic tensile, shear, bending, and so
3.1.3 resin—any polymer that is a basic material for plas- forth). If the performance of a device under its indicated use
tics.6 includes loading, hydrolytic aging alone is NOT sufficient to
fully characterize the device.
4. Summary of Test Method 5.3.2 Mechanically Loaded Hydrolytic Evaluation—The ob-
4.1 Samples of polymer resins, semi-finished components, jective of loading is to approximate (at 37°C in buffered saline)
finished surgical implants, or specially designed test specimens the actual expected device service conditions so as to better
fabricated from those resins are placed in buffered saline understand potential physicochemical changes that may occur.
solution at physiologic temperatures. Samples are periodically Such testing can be considered as necessary if loading can be
removed and tested for various material or mechanical prop- reasonably expected under in vivo service conditions. When
erties at specified intervals. The required test intervals vary feasible, test specimens should be loaded in a manner that
greatly depending on the specific polymeric composition. For simulates in vivo conditions, both in magnitude and type of
example, poly(l-lactide) and poly(e-caprolactone) degrade very loading. Clinically relevant cyclic load tests may include
slowly and can require two or more years for complete testing to failure or for a specified number of cycles followed
degradation. Polymers based substantially on glycolide can by testing to evaluate physicochemical properties.
completely degrade in two to three months depending on the 5.3.2.1 Static Loading—It is notable that for some poly-
exact composition and on the size of the specimen. Degrada- meric materials it has been shown that a constant load results
tion time is also strongly affected by specimen size, polymer in the same failure mechanism (for example, creep) and is the
molar mass, and crystallinity. worst case when compared to a cyclic load (where the
maximum amplitude of the cyclic load is equal to the constant
NOTE 2—The term molecular weight (abbreviated MW) is obsolete and
should be replaced by the SI (Système Internationale) equivalent of either load). Thus, in specific cases it may be acceptable to simplify
relative molecular mass (Mr), which reflects the dimensionless ratio of the the test by using a constant load even when the anticipated in
mass of a single molecule to an atomic mass unit [see ISO 31–8], or molar vivo loading is cyclic. It is encumbent upon the user of this test
mass (M), which refers to the mass of a mole of a substance and is method to demonstrate through experiment or specific refer-
typically expressed as grams/mole. For polymers and other ence that this simplification is applicable to the polymer under
macromolecules, use of the symbols Mw, Mn, and Mz continue, referring
to mass-average molar mass, number-average molar mass, and z-average investigation and does not alter the failure mode of the test
molar mass, respectively. For more information regarding proper utiliza- specimen. If such evidence is not available ,it is necessary to
tion of SI units, see NIST Special Publication SP811. recognize that static loading and cyclic loading are measuring
different material properties and are not comparable. Using one
5. Significance and Use to replace the other could lead to misinterpretation of the
5.1 This test method is intended to help assess the degrada- results.
tion rates (that is, the mass loss rate) and changes in material or
NOTE 3—Caution must be taken to ensure that fixturing does not
structural properties, or both, of HDP materials used in surgical introduce artifactual performace or degradation issues, or both. An
implants. Polymers that are known to degrade primarily by example is the use of rigid foam block, which restricts swelling &
hydrolysis include but are not limited to homopolymers and expansion and can elevate pull out strength test results from sample
copolymers of l-lactide, d-lactide, d,l-lactide glycolide, compression within the block. Additionally, restricted perfusion due to the
caprolactone, and p-dioxanone.7 closed cell nature of the foam can result in concentration of acidic
byproducts that result in accelerated degradation when compared to a
5.2 This test method may not be appropriate for all types of normally perfused and buffered in vivo condition.
implant applications or for all known absorbable polymers. NOTE 4—When performing degradation testing under load, it may be
The user is cautioned to consider the appropriateness of the test necessary to consider and monitor polymer creep during testing, which
may be significant.
method in view of the materials being tested and their potential
application (see X1.1.1). 5.4 Absorbable devices subjected to flow conditions (for
5.3 Since it is well known that mechanical loading can example, vascular stents, particularly those with a drug eluting
increase the degradation rate of absorbable polymers, the component) may degrade more rapidly than the same device
presence and extent of such loading needs to be considered maintained under static degradation test conditions. When it is
when comparing in vitro behavior with that expected or feasible to estimate the flow conditions that an implant will be
observed in vivo. subjected to in vivo and replicate them in vitro the degradation
5.3.1 Mechanically Unloaded Hydrolytic Evaluation— study should be conducted under flow conditions. However,
Conditioning of a hydrolysable device under mechanically details regarding appropriate flow modeling are beyond the
scope of this test method.
6
5.5 Sterilization of HDP materials should be expected to
Polymer Technology Dictionary, Tony Whelan ed., Chapman & Hall, 1994.
7
Handbook of Biodegradable Polymers, A.J. Domb ed., Harwood Academic cause changes in molar mass or structure, or both, of the
Publishers, 1997. polymers. This can affect the initial mechanical and physical

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 F1635 − 11
properties of a material or device, as well as its subsequent rate 6.5 Balance—A calibrated weighing device capable of mea-
of degradation. Therefore, if a test is intended to be represen- suring the weight of a sample to a precision of 0.1 % of its
tative of actual performance in vivo, specimens shall be initial weight. A balance having precision to 0.05 % or 0.01 %
packaged and sterilized in a manner consistent with that of the will facilitate establishment of an appropriate specimen drying
final device. Non-sterilized specimens may be included for period.
comparative purposes. 6.6 Other—Additional equipment as deemed appropriate by
6. Materials and Apparatus the specific test method.
6.1 Physiologic Soaking Solution—A phosphate-buffered
saline (PBS) solution shall be used. The pH of the solution 7. Sampling
shall be maintained at 7.4 6 0.2 (see X1.3) unless it is 7.1 Weight Loss—A minimum of three samples shall be
determined through documented literature or self-advised tested per time period.
study that the pH should be different due to the physiological 7.2 Molar Mass—A minimum of three samples shall be
conditions of the intended application (this may require use of tested per time period.
an alternate buffer system). Limited excursions outside of the
specified pH range are tolerable provided the time weighted 7.3 Mechanical Testing—A minimum of six samples shall
average pH after buffer replenishment is maintained within this be tested per time period.
range (see X1.3.1). The ionic concentration should be in the NOTE 5—Statistical significance may require more than the minimum
physiological range for the intended application (for example, number of samples to be tested.
a solution that contains 0.1 M phosphate buffer and 0.1 M NaCl 7.4 Solution Temperature and pH—Soaking solutions shall
would be appropriate for most tissue or blood contact devices). be tested on a periodic basis throughout the test duration. The
The solution-to-HDP mass ratio shall be as high as practical. required test period is dependent on the degradation rate of the
Although there is some experience with ratios as low as 20:1, test polymer, the solution/specimen mass ratio, and the solu-
the experimenter is cautioned that at lower ratios (that is, less tion’s buffering capacity; once per week is generally practical
buffering capacity) the solution pH may change more quickly. and suggested. In cases where no prior knowledge of the
In accordance with 9.1.3 and X1.4, aging/testing is to be degradation rate is available, it is suggested that the pH be
terminated if the solution temperature or pH are allowed to tested at least daily until a baseline is established. This
drift outside of the specified ranges. Higher solution/specimen increased sampling frequency may need to be repeated during
ratios (for example, 100:1) will be more likely to facilitate periods of elevated mass loss (that is, pH change).
maintenance of stable aging conditions.
6.1.1 Over the course of the study, the pH should be
8. Sample and Test Specimen
monitored frequently and the solution shall be changed peri-
odically in order to maintain the pH within the acceptable 8.1 All test samples shall be representative of the material
limits. Refer to X1.5 for additional information. under evaluation.
6.1.2 Other physiologic solutions, such as bovine serum, 8.1.1 For most HDP resins, inter-lot variations in the molar
may be substituted provided the solution is properly buffered. mass and residual monomer content can be significant. Since
An anti-microbial additive should be used to inhibit the growth these factors can strongly affect degradation rates, molar mass
of microorganisms in the solution during the test period but the (or inherent viscosity) and residual monomer content of the
investigator must demonstrate through literature reference or source resin and fabricated test parts need to be understood.
experimentation that the chosen antimicrobial does not affect 8.1.2 Where evaluation aims allow, it is recommended that
the degradation rate. Section X1.6 provides additional infor- samples comparing variations in design be produced from the
mation. The appropriate MSDS should always be consulted same material lot (or batch) and under the same fabrication
concerning toxicity, safe use, and disposal of such additives. conditions.
6.2 Sample Container—A self-contained, inert container 8.1.3 When testing for inter-lot variability in degradation
(bottle, jar, vial, and so forth) capable of holding the test rate (for example, for process validation purposes), a minimum
sample and the required volume of physiologic soaking solu- of three resin lots should be used.
tion (see X1.7). Multiple samples may be stored in the same 8.2 If a test is intended to be representative of actual
container provided that suitable sample separation is main- performance in vivo, specimens shall be packaged and steril-
tained to allow fluid access to each sample surface and to ized in a manner consistent with that of the final device.
preclude sample-to-sample contact. Each container must be Unsterilized control specimens may be included for compara-
sealable against solution loss by evaporation. tive purposes showing the effects of sterilization.
6.3 Constant Temperature Bath or Oven—An aqueous bath
or heated air oven capable of maintaining the samples and 9. Procedure
containers at physiologic temperatures, 37 6 2°C, for the 9.1 Test A, Weight Loss:
specified testing periods. 9.1.1 Test samples, in either resin or fabricated form, shall
6.4 pH Meter—A pH metering device sensitive in the be weighed to a precision of 0.1 % of the total sample weight
physiological range (pH 6 to pH 8) with a precision of 0.02 or prior to placement in the physiological solution. Samples shall
better. be dried to a constant weight before initial weighing (see Note

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 F1635 − 11
6 and X1.8). Drying conditions, including final relative humid- physiological solution (time zero). Relevant ASTM test meth-
ity (if applicable), shall be reported and may include the use of ods may include one or more of the following:
a desiccator, partial vacuum, or elevated temperatures (see Test Method D638
Note 7). Test Method D671
9.1.2 Test samples shall be fully immersed in the physi- Test Method D695
ological solution for a specified period of time as discussed in Test Method D747
4.1 (for example, 1 week, 2 weeks, and so forth). Test Method D790
9.1.3 Upon completion of the specified time period, each Test Method D882
sample shall be removed, gently rinsed with sufficient distilled Test Method D1708
water to remove saline, placed in a tared container, and dried to Test Method D1822
a constant weight (see Note 6 and X1.8). The weight shall be 9.3.2 Fully immerse test samples in the physiological solu-
recorded to a precision of 0.1 % of the original total sample tion at 37°C for the specified period of time (for example, 1
weight. week, 2 weeks, and so forth).
9.3.3 Remove samples at each specified time period
NOTE 6—Drying to a constant weight may be quantified as less than
0.1 % weight change over a period of 48 h, or less than 0.05 % change in throughout the duration of the study and test using the
24 h if the balance used is capable of such precision. Section X1.8 originally selected mechanical test methods and conditions.
provides additional information. Unless otherwise deemed relevant, samples should be tested in
NOTE 7—Elevated temperatures may be used to assist drying of the a non-dried or wet condition. Section X1.9 provides additional
sample provided that the temperature used does not induce material or information. Testing conditions, wet versus dry, testing
chemical changes in the sample. Vacuum drying with a dry gas purge can
alternately be used without concern for material degradation. The drying temperature, and so forth, should be reported.
conditions used for the samples prior to aging and for the samples 9.3.4 Unless specifically germane to the testing scheme,
retrieved at each test interval shall be identical. The actual drying samples shall be retired after the completion of each test.
conditions used are to be reported.
9.4 Other Testing:
9.1.4 After weighing, the samples shall not be returned to 9.4.1 The characterization of other material properties and
the physiological solution and shall be retired from the study. use of other test methods (for example, thermal properties
9.2 Test B, Molar Mass: measured using Differential Scanning Calorimetry) may also
9.2.1 Prior to placement of samples in the physiological be performed at each test interval. Conditioning and testing
solution, determine the molar mass of representative samples parameters, as well as test results, should all be recorded and
using either inherent viscosity (logarithmic viscosity number) reported.
testing following the recommendations of Test Method D2857 9.4.2 The degradation products of the HDP under investi-
or size exclusion chromatography. Testing shall be done in a gation may be analyzed. ISO 10993–9 provides guidelines for
solvent appropriate for the test polymer and at a temperature identification and quantification of degradation products.
sufficient to allow solubility and temperature control. For 9.4.3 Biological response to HDP materials or their degra-
example, the molar mass of poly(l-lactide) should be deter- dation products may be investigated. Practice F748 and ISO
mined in chloroform at 30°C. The sample dilution ratio 10993–1 provide guidelines for the selection of in vitro and in
(mg/cm3) and test temperature shall be reported. Alternative vivo biocompatibility tests for medical devices and materials.
means of molar mass determination may be used when
feasible. 10. Test Termination
9.2.2 Test samples shall be fully immersed in the physi- 10.1 Testing of samples shall be terminated when one or
ological solution for the specified period of time (for example, more of the following has occurred:
1 week, 3 weeks, 52 weeks, and so forth). 10.1.1 A predetermined end point has been reached, that is,
9.2.3 Samples shall be removed at each specified time elapsed time (for example, 2 years), percent weight loss,
period throughout the duration of the test, dried as in 9.1.1, and minimum molar mass, percent strength loss, and so forth.
tested for inherent viscosity as above. For polymers that 10.1.2 Sample integrity has been compromised by the
undergo very rapid degradation, the molar mass may change progression of degradation or by mechanical damage to the
significantly during the drying procedure, causing an overesti- point that meaningful and reliable data may no longer be
mate of the degradation rate. Therefore the user should exercise obtained.
caution in interpretation of this data. This caution does not 10.1.3 The soaking solution temperature or pH has drifted
generally apply to mass loss measurements, since continued outside of the ranges specified in Section 6. Any sample
degradation after the samples are placed in tared containers properties obtained since the last in-range temperature and pH
will not affect the sample mass unless the degradation products measurements shall be considered invalid and so noted in the
are volatile. For rapidly degrading HDP materials, alternative study report (see X1.4).
procedures such as vacuum drying should be considered.
9.3 Test C, Mechanical Testing: 11. Report
9.3.1 Determine the appropriate mechanical properties of 11.1 Report the following information:
representative samples of resin or fabricated forms using 11.1.1 Test material description, batch or lot number and
tensile, compressive, torque, bending or other appropriate dimensions (as appropriate).
mechanical tests prior to placement of the samples in the 11.1.2 Solution composition and preparation procedures.

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11.1.3 Measurements of solution temperature and pH with 12. Precision
time, if applicable.
12.1 Intralaboratory and interlaboratory reproducibility has
11.1.4 Sample weights expressed as an average percentage
not been systematically determined.
loss, initial and subsequent by time period.
11.1.5 Molar mass, initial and subsequent by time period.
11.1.6 Mechanical properties (tensile strength, compressive 13. Keywords
strength, stiffness, elongation at break, and so forth) appropri- 13.1 absorbable; bioabsorbable; degradation; in vitro; hy-
ate for tests performed, at time zero and at each time period. drolytically degradable polymer; hydrolysis; PLA, poly(l-lactic
11.1.7 Other material properties measured. acid); poly(d-lactide); poly(d,l-lactide); PGA, poly(glycolide);
11.1.8 Reason(s) for test termination. poly(caprolactone); poly(p-dioxanone); surgical implant

APPENDIXES

(Nonmandatory Information)

X1. RATIONALE

X1.1 With the development of absorbable polymers for use received from two consultants to the Task Group that this range
in implantable devices, there is a need to define standard of pH values was representative of that found in human blood
testing methods that aid in characterizing material and me- and extra-cellular fluid. For devices intended for use in
chanical properties with time in a simulated physiological applications where the fluid environment has a different pH
environment. This test method is intended only as a framework (for example, urethral stents exposed to urine), a different pH
for assessing degradation of implant materials and devices. specification may be more appropriate. It is then incumbent
X1.1.1 This test method is written for use in characterizing upon the researcher to properly document the choice of
hydrolytically degradable polymer resins and devices. Given environmental conditions. The range of 60.2 should be main-
the wide variety of absorbable polymer compositions currently tained regardless of the chosen target value of pH.
available or under investigation, it is incumbent upon the X1.3.1 For this application, the time weighted average
researcher to show through reference or experimentation that (TWA) pH is computed using the following equation:
other degradation mechanisms are not dominant for the mate-
~ pH1 t 1 ! 1 ~ pH2 t 2 ! 1 ~ pH3 t 3 ! 1…1 ~ pHn t n !
rial and the intended use. For example, certain bio-polymers TWA pH 5 (X1.1)
~ t 1 1t 2 1t 3 1…1t n !
(for example, collagen based materials such as gelatin) are
known to degrade in vivo primarily by enzymatic attack and the where:
use of this method would give a serious underestimation of the pH = measured pH at the respective sampling point,
degradation rate. It has also been hypothesized that enzymatic t1 = elapsed time from buffer replenishment, and
degradation may play a role in the degradation of some tn = elapsed time from the prior sampling point.
synthetic polymers. in vitro studies have shown that in suffi- X1.3.2 It is also recommended that the starting pH of the
cient concentration certain enzymes (for example, esterases) solution be made as close to the upper end of the chosen range
may increase degradation rates of specific polymers with as possible since all known HDP systems generate degradation
susceptible bonds. However, when comparisons have been products that are acidic.
made between in vitro and in vivo degradation rates of
equivalent samples of hydrolytically degradable polymers X1.3.3 Information regarding the actual impact both alka-
under unloaded conditions, the results have consistently shown line (pH = 10.09) and acidic (pH = 5.25) pH has on the
that in vivo acceleration of degradation is either not present or mechanical properties of absorbable sutures (as observed at pH
is within the error of measurement.7 = 7.44) can be found in Chu.8

X1.2 It is recognized that the use of test coupons or X1.4 Termination of testing, following a significant change
specimens in forms other than final implant configurations may in solution temperature or pH, is indicated in 10.1.3 in order to
be helpful in assessing relevant polymer properties. For avoid the generation of invalid results once meaningful loss of
example, rectangular or round rods may be necessary to control over soaking conditions has occurred.
measure flexural properties, while a screw geometry may be
required to evaluate the performance of a specific implantable X1.5 A wide variety of PBS compositions is available and
device. However, specimen size, surface area, and process in common use. The components are targeted to achieve final
considerations must be addressed in order to relate in vitro solutions that exert near-physiological osmotic pressures of
degradation of test specimens to in vivo behavior of implant
devices.
8
Chu, C. C., “The Effect of pH on the in vitro Degradation of Poly(glycolide
X1.3 The pH level specified for the buffered saline solution lactide) Copolymer Absorbable Sutures,” Journal of Biomedical Materials
(that is, 7.4 6 0.2) was selected on the basis of information Research, 16, 1982, pp. 117-124.

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 F1635 − 11
approximately 280 to 300 mOsm. Common buffer concentra- round robin testing to follow issuance of this test method. The
tions range from approximately 0.01 to 0.1 M with the higher requirements stated in Note 6 are based on experience with
concentrations providing greater buffering capacity. Additional extruded 3.2-mm diameter rods of l-PLA dried under nominal
information about the composition and preparation of pH full vacuum at room temperature. Constant weight was
proportioned monobasic-dibasic phosphate buffer solutions achieved after 3 to 4 days.
may be found in a handbook available from Calbiochem Inc.,
a division of EMD Biosciences.9 X1.9 Task Group members have observed the use of wet
versus dry test conditions to result in significant differences in
X1.6 Addition of sodium azide at a concentration of 0.1 %
some mechanical property measurements. It is recommended
is common. Other anitimicrobials that are commonly used
that testing be performed on specimens that are immersed in
include penicillin (100 U/mL), streptomycin (100 µg/mL), and
amphotericin (0.25 to 2.5 µg/mL). Regardless of the antibiotic water at 37°C at the time of testing. Report whichever
or antimicrobial agent(s) that is used, it is incumbent upon the conditions are actually used.
investigator to determine that their use does not affect the
X1.10 This test method does not suggest the use of agitation
degradation rate of the HDP under investigation. These mate-
rials may be hazardous and all persons using them should during soaking for the following reasons. First, in the majority
review the MSDS before handling and use all recommended of applications for absorbable polymers, implantation occurs in
safety precautions. tissues that will not expose the implants to measurable fluid
flow. Even in cases where turnover of fluids occurs, such as in
X1.7 The inert containers used to hold the samples and the abdominal cavity, the device will become encapsulated in
solution are usually glass or plastic. However, for some (short fibrous tissue within two weeks of implantation. The presence
duration) tests, stainless steel containers may be appropriate. of the fibrous capsule will shield the material from fluid flow
X1.8 Revision or further specification of requirements for and limit transport mechanisms to diffusion. Furthermore,
drying to a constant weight are intended to be developed from studies comparing static in vitro degradation rates to in vivo
degradation rates for several HDP materials have shown that
9
Available from EMD Biosciences, Inc., 10394 Pacific Center Ct., San Diego, the in vitro results are predictive of the in vivo degradation
CA 92121. http://www.emdbiosciences.com rates.7

X2. TERMINOLOGY

X2.1 Synthetic implants fabricated from hydrolysable absorbable/absorption to describe implantable synthetic hydro-
alpha-hydroxy polyesters have been described as “absorbable” lysable polymers & devices. The prefix “bio” is avoided since
since the first polyglycolide based sutures were commercial- it is redundant in the context of implant applications. “Resorb”
ized in the United States in the 1970s. At that time, both and its derivatives are avoided since they are accepted medical
poly(glycolide) (DEXON - Davis & Geck) and poly(glycolide- terms routinely utilized to describe natural resorption processes
co-lactide) copolymer (VICRYL - Ethicon) based sutures were present in dynamic tissue, such as osteoclastic driven bone
classified as “Absorbable Surgical Suture” by the United States remodeling. “Degrade” and its various derivatives are avoided
Pharmacopeia (USP) and the United States Food & Drug when referring to either an implantable device or raw material
Administration (US-FDA), a designation that remains to this since common utilization is routinely applied broadly to
day. In contrast with “Nonabsorbable Surgical Suture,” syn- include composting and other natural processes (including
thetic glycolide-lactide and collagen based sutures undergo ultra-violet radiation) that cause materials to either intention-
hydrolytic and/or enzymatic driven chain scission, generating
ally or unintentionally break down into chemical and/or
byproducts that are then absorbed by the body. Since
particulate matter. However, use of the term “degrade” and its
designation, other terms such as “degradable” and “resorbable”
derivatives is considered acceptable when referring to chain
have been used interchangeably to describe absorbable
implants, with the prefix “bio-” often applied to all these terms. scission within the implantable device or polymer (e.g. “The
absorbable implant degrades through hydrolysis.” or “During
X2.2 Based on historical usage and regulatory precedent, extrusion, absorbable polyglycolide is prone to thermal
this document preferentially utilizes the term absorb/ degradation.”).

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