ASTM F2902-16
(Guide)Standard Guide for Assessment of Absorbable Polymeric Implants
Standard Guide for Assessment of Absorbable Polymeric Implants
SIGNIFICANCE AND USE
4.1 This guide is aimed at providing guidance for assessments and evaluations to aid in preclinical research and development of various absorbable components and devices.
4.2 This guide includes brief descriptions of various intended uses, processing conditions, assessments, and both qualitative and quantitative analyses for raw materials to finished product components.
4.3 The user is encouraged to utilize appropriate ASTM and other standards to conduct the physical, chemical, mechanical, biocompatibility, and preclinical tests on absorbable materials, device components, or devices prior to assessment in an in vivo model.
4.4 Whenever an absorbable material is mixed or coated with other substances (bioactive, polymeric, or otherwise), the physical and degradation properties of the resulting composite may differ significantly from the base polymer. Thus, unless prior experience can justify otherwise, performance characterizations described herein should be conducted on the composite construct rather than on individual components.
4.5 Assessments of absorbable materials should be performed in accordance with the provisions of the FDA Good Laboratories Practices Regulations 21 CFR 58, where feasible.
4.6 Studies to support regulatory approval for clinical or commercial use, or both, should conform to appropriate nationally adopted directives or guidelines, or both, for the development of medical devices [for example, CE approval; US-FDA Investigational Device Exemption (IDE), Pre- Market Approval (PMA), or 510K submission].
4.7 Assessments based upon data from physical, chemical, mechanical, biocompatibility, and preclinical testing models are highly valuable but carry inherent limitations. Thus, the clinical relevance of each assessment needs to be carefully considered and the user is cautioned that pre-clinical evaluations may not be predictive of human clinical performance.
SCOPE
1.1 This guide describes general guidelines for the chemical, physical, mechanical, biocompatibility, and preclinical assessments of implantable synthetic polymeric absorbable devices. This guide also describes evaluation methods that are potentially useful and should be considered when assessing absorbable implants or implant components.
1.2 The described evaluations may assist a manufacturer in establishing the safety and effectiveness of an absorbable implant device. This listing of assessment methods may also be utilized to assist in establishing substantial equivalence to an existing commercially marketed device. However, these polymeric material-oriented guidelines do not necessarily reflect the total needs for any particular implant application (for example, orthopedic, cardiovascular), which may require additional and potentially essential application-specific evaluations.
1.3 This guide is intended to cover all forms of absorbable polymeric components and devices, including solid (for example, injection-molded) and porous (for example, fibrous) forms. This guide is also intended to cover devices fabricated from amorphous and/or semi-crystalline absorbable polymer systems.
1.4 This guide has been generated with principal emphasis on the evaluation of devices formed from synthetic polymers that degrade in vivo primarily through hydrolysis (for example, α-hydroxy-polyesters). Evaluation methods suggested herein may or may not be applicable to implants formed from materials that, upon implantation, are substantially degraded through other mechanisms (for example, enzymatically induced degradation).
1.5 This guide references and generally describes various means to assess absorbable materials, components, and devices. The user needs to refer to specific test methods for additional details. Additionally, some of the recommended test methods may require modification to address the properties of a particular device, construct, or application.
1.6 Adherence to all aspects of these g...
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Designation: F2902 − 16
Standard Guide for
1
Assessment of Absorbable Polymeric Implants
This standard is issued under the fixed designation F2902; 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 methods may require modification to address the properties of
a particular device, construct, or application.
1.1 This guide describes general guidelines for the
1.6 Adherence to all aspects of these guidelines is not
chemical, physical, mechanical, biocompatibility, and preclini-
mandatory,inthatassessmentsandtestslistedwithinthisguide
cal assessments of implantable synthetic polymeric absorbable
are not necessarily relevant for all absorbable implant systems
devices. This guide also describes evaluation methods that are
and applications.
potentially useful and should be considered when assessing
absorbable implants or implant components.
1.7 Absorbable polymers used as a matrix to control the in
vivo release of bioactive agents (drugs, antimicrobials, and so
1.2 The described evaluations may assist a manufacturer in
forth) may be evaluated according to many of the methods
establishing the safety and effectiveness of an absorbable
described herein. However, additional test methods not cov-
implantdevice.Thislistingofassessmentmethodsmayalsobe
ered by this guide will likely be needed to evaluate a bioactive
utilized to assist in establishing substantial equivalence to an
agent’s composition, loading, release kinetics, safety, and
existing commercially marketed device. However, these poly-
efficacy.
meric material-oriented guidelines do not necessarily reflect
the total needs for any particular implant application (for
1.8 Composites of absorbable polymers with ceramics
example, orthopedic, cardiovascular), which may require ad-
and/or metals may be evaluated according to many of the
ditional and potentially essential application-specific evalua-
methods described herein. However, additional test methods
tions.
not covered by this guide will likely be needed to evaluate the
composite’s other component(s).
1.3 This guide is intended to cover all forms of absorbable
polymeric components and devices, including solid (for
1.9 The values stated in SI units are to be regarded as
example, injection-molded) and porous (for example, fibrous)
standard. No other units of measurement are included in this
forms. This guide is also intended to cover devices fabricated
standard.
from amorphous and/or semi-crystalline absorbable polymer
1.10 This standard does not purport to address all of the
systems.
safety concerns, if any, associated with its use. It is the
1.4 This guide has been generated with principal emphasis responsibility of the user of this standard to establish appro-
on the evaluation of devices formed from synthetic polymers priate safety and health practices and determine the applica-
that degrade in vivo primarily through hydrolysis (for example,
bility of regulatory limitations prior to use.
α-hydroxy-polyesters). Evaluation methods suggested herein
may or may not be applicable to implants formed from 2. Referenced Documents
2
materials that, upon implantation, are substantially degraded
2.1 ASTM Standards:
through other mechanisms (for example, enzymatically in-
D570 Test Method for Water Absorption of Plastics
duced degradation).
D638 Test Method for Tensile Properties of Plastics
D695 Test Method for Compressive Properties of Rigid
1.5 This guide references and generally describes various
Plastics
means to assess absorbable materials, components, and de-
D792 Test Methods for Density and Specific Gravity (Rela-
vices. The user needs to refer to specific test methods for
tive Density) of Plastics by Displacement
additional details.Additionally, some of the recommended test
D1042 Test Method for Linear Dimensional Changes of
Plastics Caused by Exposure to Heat and Moisture
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
2
F04.11 on Polymeric Materials. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Dec. 1, 2016. Published January 2017. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2012. Last previous edition approved in 2012 as F2902 - 12. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2902-16. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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...
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: F2902 − 12 F2902 − 16
Standard Guide for
1
Assessment of Absorbable Polymeric Implants
This standard is issued under the fixed designation F2902; 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 guide describes general guidelines for the chemical, physical, mechanical, biocompatibility, and preclinical
assessments of implantable synthetic polymeric absorbable devices. This guide also describes evaluation methods that are
potentially useful and should be considered when assessing absorbable implants or implant components.
1.2 The described evaluations may assist a manufacturer in establishing the safety and effectiveness of an absorbable implant
device. This listing of assessment methods may also be utilized to assist in establishing substantial equivalence to an existing
commercially marketed device. However, these polymeric material-oriented guidelines do not necessarily reflect the total needs
for any particular implant application (for example, orthopedic, cardiovascular), which may require additional and potentially
essential application-specific evaluations.
1.3 This guide is intended to cover all forms of absorbable polymeric components and devices, including solid (for example,
injection-molded) and porous (for example, fibrous) forms. This guide is also intended to cover devices fabricated from amorphous
and/or semi-crystalline absorbable polymer systems.
1.4 This guide has been generated with principal emphasis on the evaluation of devices formed from synthetic polymers that
degrade in vivo primarily through hydrolysis (for example, α-hydroxy-polyesters). Evaluation methods suggested herein may or
may not be applicable to implants formed from materials that, upon implantation, are substantially degraded through other
mechanisms (for example, enzymatic action).enzymatically induced degradation).
1.5 This guide references and generally describes various means to assess absorbable materials, components, and devices. The
user needs to refer to specific test methods for additional details. Additionally, some of the recommended test methods may require
modification to address the properties of a particular device, construct, or application.
1.6 Adherence to all aspects of these guidelines is not mandatory, in that assessments and tests listed within this guide are not
necessarily relevant for all absorbable implant systems and applications.
1.7 Absorbable polymers used as a matrix to control the in vivo release of bioactive agents (drugs, antimicrobials, and so forth)
may be evaluated according to many of the methods described herein. However, additional test methods not covered by this guide
will likely be needed to evaluate a bioactive agent’s composition, loading, release kinetics, safety, and efficacy.
1.8 Composites of absorbable polymers with ceramics and/or metals may be evaluated according to many of the methods
described herein. However, additional test methods not covered by this guide will likely be needed to evaluate the composite’s
other component(s).
1.9 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.10 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:
D570 Test Method for Water Absorption of Plastics
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.11
on Polymeric Materials.
Current edition approved Dec. 1, 2012Dec. 1, 2016. Published January 2013January 2017. Originally approved in 2012. Last previous edition approved in 2012 as F2902
- 12. DOI: 10.1520/F2902–12.10.1520/F2902-16.
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. Un
...
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