ASTM F1635-16
(Test Method)Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
Standard Test Method for <emph type="bdit">in vitro</emph> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
SIGNIFICANCE AND USE
5.1 This test method is intended to help assess the degradation rates (that is, the mass loss rate) and changes in material or structural properties, or both, of HDP materials used in surgical implants. Polymers that are known to degrade primarily by hydrolysis include but are not limited to homopolymers and copolymers of l-lactide, d-lactide, d,l-lactide glycolide, caprolactone, and p-dioxanone.7
5.2 This test method may not be appropriate for all types of implant applications or for all known absorbable polymers. The user is cautioned to consider the appropriateness of the test method in view of the materials being tested and their potential application (see X1.1.1).
5.3 Since it is well known that mechanical loading can increase the degradation rate of absorbable polymers, the presence and extent of such loading needs to be considered when comparing in vitro behavior with that expected or observed in vivo.
5.3.1 Mechanically Unloaded Hydrolytic Evaluation—Conditioning of a hydrolysable device under mechanically unchallenged hydrolytic conditions at 37°C in buffered saline is a common means to obtain a first approximation of the degradation profile of an absorbable material or device. It does not necessarily represent actual in vivo service conditions, which can include mechanical loading in a variety of forms (for example. static tensile, cyclic tensile, shear, bending, and so forth). If the performance of a device under its indicated use includes loading, hydrolytic aging alone is NOT sufficient to fully characterize the device.
5.3.2 Mechanically Loaded Hydrolytic Evaluation—The objective of loading is to approximate (at 37°C in buffered saline) the actual expected device service conditions so as to better understand potential physicochemical changes that may occur. Such testing can be considered as necessary if loading can be reasonably expected under in vivo service conditions. When feasible, test specimens should be loaded in a manner that simul...
SCOPE
1.1 This test method covers in vitro degradation of hydrolytically degradable polymers (HDP) intended for use in surgical implants.
1.2 The requirements of this test method apply to HDPs in various forms:
1.2.1 Virgin polymer resins, or
1.2.2 Any form fabricated from virgin polymer such as a semi-finished component of a finished product, a finished product, which may include packaged and sterilized implants, or a specially fabricated test specimen.
1.3 This test method provides guidance for mechanical loading or fluid flow, or both, when relevant to the device being evaluated. The specifics of loading type, magnitude, and frequency for a given application are beyond the scope of this test method.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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Standards Content (Sample)
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 − 16
Standard Test Method for
in vitro Degradation Testing of Hydrolytically Degradable
Polymer Resins and Fabricated Forms for Surgical
1
Implants
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 2. Referenced Documents
2
1.1 This test method covers in vitro degradation of hydro- 2.1 ASTM Standards:
lytically degradable polymers (HDP) intended for use in D638 Test Method for Tensile Properties of Plastics
surgical implants. D671 Test Method for Flexural Fatigue of Plastics by
3
Constant-Amplitude-of-Force (Withdrawn 2002)
1.2 The requirements of this test method apply to HDPs in
D695 Test Method for Compressive Properties of Rigid
various forms:
Plastics
1.2.1 Virgin polymer resins, or
D747 Test Method for Apparent Bending Modulus of Plas-
1.2.2 Any form fabricated from virgin polymer such as a
tics by Means of a Cantilever Beam
semi-finished component of a finished product, a finished D790 Test Methods for Flexural Properties of Unreinforced
product, which may include packaged and sterilized implants, and Reinforced Plastics and Electrical Insulating Materi-
or a specially fabricated test specimen. als
D882 Test Method for Tensile Properties of Thin Plastic
1.3 This test method provides guidance for mechanical
Sheeting
loadingorfluidflow,orboth,whenrelevanttothedevicebeing
D1708 Test Method forTensile Properties of Plastics by Use
evaluated. The specifics of loading type, magnitude, and
of Microtensile Specimens
frequency for a given application are beyond the scope of this
D1822 Test Method for Tensile-Impact Energy to Break
test method.
Plastics and Electrical Insulating Materials
D2857 Practice for Dilute Solution Viscosity of Polymers
1.4 The values stated in SI units are to be regarded as
F748 PracticeforSelectingGenericBiologicalTestMethods
standard. No other units of measurement are included in this
for Materials and Devices
standard.
4
2.2 ISO Standards:
1.5 This standard does not purport to address all of the
ISO 31–8 Physical Chemistry and Molecular Physics - Part
safety concerns, if any, associated with its use. It is the
8: Quantities and Units
responsibility of the user of this standard to establish appro-
ISO 10993–1 Biological Evaluation of Medical Devices—
priate safety and health practices and determine the applica-
Part 1 Evaluation and Testing
bility of regulatory limitations prior to use.
ISO 10993–9 Biological Evaluation of Medical Devices—
1.6 This international standard was developed in accor-
Part 9 Framework for Identification and Quantification of
dance with internationally recognized principles on standard-
Potential Degradation Products
ization established in the Decision on Principles for the
ISO 13781 Poly(L-lactide) resins and fabricated forms for
Development of International Standards, Guides and Recom-
surgical implants – In vitro degradation testing
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical Standards volume information, refer to the standard’s Document Summary page on
and Surgical Materials and Devices and is the direct responsibility of Subcommittee the ASTM website.
3
F04.15 on Material Test Methods. The last approved version of this historical standard is referenced on
Current edition approved Dec. 1, 2016. Published January 2017. Originally www.astm.org.
4
approved in 1995. Last previous edition approved in 2011 as F1635 – 11. DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F1635-16. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F1635 − 16
5
2.3 NIST Standard: copolymers of l-lactide, d-lactide, d,l-lactide glycolide,
7
NIST Special Publication SP811 Guide for the Use of the caprolactone, and p-dioxanone.
International System of Units (SI)
5.2 This test method may not be appropriate for all types of
implant applications or for all known absorbable polymers.
3. Terminology
Theuseriscautionedtoconsidertheappropriatenessofthetest
3.1 Defini
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F1635 − 11 F1635 − 16
Standard Test Method for
in vitro Degradation Testing of Hydrolytically Degradable
Polymer Resins and Fabricated Forms for Surgical
1
Implants
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
1.1 This test method covers in vitro degradation of hydrolytically degradable polymers (HDP) intended for use in surgical
implants.
1.2 The requirements of this test method apply to HDPs in various forms:
1.2.1 Virgin polymer resins, or
1.2.2 Any form fabricated from virgin polymer such as a semi-finished component of a finished product, a finished product,
which may include packaged and sterilized implants, or a specially fabricated test specimen.
1.3 This test method provides guidance for mechanical loading or fluid flow, or both, when relevant to the device being
evaluated. The specifics of loading type, magnitude, and frequency for a given application are beyond the scope of this test method.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
D638 Test Method for Tensile Properties of Plastics
3
D671 Test Method for Flexural Fatigue of Plastics by Constant-Amplitude-of-Force (Withdrawn 2002)
D695 Test Method for Compressive Properties of Rigid Plastics
D747 Test Method for Apparent Bending Modulus of Plastics by Means of a Cantilever Beam
D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
D882 Test Method for Tensile Properties of Thin Plastic Sheeting
D1708 Test Method for Tensile Properties of Plastics by Use of Microtensile Specimens
D1822 Test Method for Tensile-Impact Energy to Break Plastics and Electrical Insulating Materials
D2857 Practice for Dilute Solution Viscosity of Polymers
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
4
2.2 Other Referenced Standard:ISO Standards:
ISO 31–8 Physical Chemistry and Molecular Physics - Part 8: Quantities and Units
ISO 10993–1 Biological Evaluation of Medical Devices—Part 1 Evaluation and Testing
ISO 10993–9 Biological Evaluation of Medical Devices—Part 9 Framework for Identification and Quantification of Potential
Degradation Products
NIST Special Publication SP811ISO 13781 Guide for the Use of the International System of Units (SI)Poly(L-lactide) resins and
fabricated forms for surgical implants – In vitro degradation testing
1
This test method is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
Current edition approved March 1, 2011Dec. 1, 2016. Published March 2011January 2017. Originally approved in 1995. Last previous edition approved in 20042011 as
F1635 – 04a.F1635 – 11. DOI: 10.1520/F1635-11.10.1520/F1635-16.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
The last approved version of this historical standard is referenced on www.astm.org.
4
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F1635 − 16
5
2.3 NIST Standard:
NIST Special Publication SP811 Guide for the Use of the International System of Units (SI)
3. Terminology
3.1 Definitions:
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 cells and/or tissue.
NOTE 1—See Appendix X2 for a discussion regarding the usage of absorbable and ot
...
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