ASTM F2902-12
(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, enzymatic action).
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 ...
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Designation: F2902 − 12
Standard Guide for
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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 1.6 Adherence to all aspects of these guidelines is not
mandatory,inthatassessmentsandtestslistedwithinthisguide
1.1 This guide describes general guidelines for the
are not necessarily relevant for all absorbable implant systems
chemical, physical, mechanical, biocompatibility, and preclini-
and applications.
cal assessments of implantable synthetic polymeric absorbable
devices. This guide also describes evaluation methods that are 1.7 Absorbable polymers used as a matrix to control the in
vivo release of bioactive agents (drugs, antimicrobials, and so
potentially useful and should be considered when assessing
absorbable implants or implant components. forth) may be evaluated according to many of the methods
described herein. However, additional test methods not cov-
1.2 The described evaluations may assist a manufacturer in
ered by this guide will likely be needed to evaluate a bioactive
establishing the safety and effectiveness of an absorbable
agent’s composition, loading, release kinetics, safety, and
implantdevice.Thislistingofassessmentmethodsmayalsobe
efficacy.
utilized to assist in establishing substantial equivalence to an
existing commercially marketed device. However, these poly- 1.8 Composites of absorbable polymers with ceramics
meric material-oriented guidelines do not necessarily reflect and/or metals may be evaluated according to many of the
the total needs for any particular implant application (for methods described herein. However, additional test methods
example, orthopedic, cardiovascular), which may require ad- not covered by this guide will likely be needed to evaluate the
ditional and potentially essential application-specific evalua- composite’s other component(s).
tions.
1.9 The values stated in SI units are to be regarded as
1.3 This guide is intended to cover all forms of absorbable standard. No other units of measurement are included in this
polymeric components and devices, including solid (for standard.
example, injection-molded) and porous (for example, fibrous)
1.10 This standard does not purport to address all of the
forms. This guide is also intended to cover devices fabricated
safety concerns, if any, associated with its use. It is the
from amorphous and/or semi-crystalline absorbable polymer
responsibility of the user of this standard to establish appro-
systems.
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
1.4 This guide has been generated with principal emphasis
on the evaluation of devices formed from synthetic polymers
2. Referenced Documents
that degrade in vivo primarily through hydrolysis (for example,
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α-hydroxy-polyesters). Evaluation methods suggested herein
2.1 ASTM Standards:
may or may not be applicable to implants formed from
D570 Test Method for Water Absorption of Plastics
materials that, upon implantation, are substantially degraded
D638 Test Method for Tensile Properties of Plastics
through other mechanisms (for example, enzymatic action).
D695 Test Method for Compressive Properties of Rigid
Plastics
1.5 This guide references and generally describes various
D792 Test Methods for Density and Specific Gravity (Rela-
means to assess absorbable materials, components, and de-
tive Density) of Plastics by Displacement
vices. The user needs to refer to specific test methods for
D1042 Test Method for Linear Dimensional Changes of
additional details.Additionally, some of the recommended test
Plastics Caused by Exposure to Heat and Moisture
methods may require modification to address the properties of
D2990 Test Methods for Tensile, Compressive, and Flexural
a particular device, construct, or application.
Creep and Creep-Rupture of Plastics
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This guide is under the jurisdiction of ASTM Committee F04 on Medical and
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Surgical Materials and Devices and is the direct responsibility of Subcommittee For referenced ASTM standards, visit the ASTM website, www.astm.org, or
F04.11 on Polymeric Materials. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved Dec. 1, 2012. Published January 2013. DOI: 10.1520/ Standards volume information, refer to the standard’s Document Summary page on
F2902–12. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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