ASTM F2902-16e1
(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, sutures, and dermal fillers), 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 Adhere...
General Information
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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.
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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
ε NOTE—Editorial corrections were made throughout in May 2017.
1. Scope additional details.Additionally, some of the recommended test
methods may require modification to address the properties of
1.1 This guide describes general guidelines for the
a particular device, construct, or application.
chemical, physical, mechanical, biocompatibility, and preclini-
cal assessments of implantable synthetic polymeric absorbable 1.6 Adherence to all aspects of these guidelines is not
mandatory,inthatassessmentsandtestslistedwithinthisguide
devices. This guide also describes evaluation methods that are
potentially useful and should be considered when assessing are not necessarily relevant for all absorbable implant systems
and applications.
absorbable implants or implant components.
1.7 Absorbable polymers used as a matrix to control the in
1.2 The described evaluations may assist a manufacturer in
vivo release of bioactive agents (drugs, antimicrobials, and so
establishing the safety and effectiveness of an absorbable
forth) may be evaluated according to many of the methods
implantdevice.Thislistingofassessmentmethodsmayalsobe
described herein. However, additional test methods not cov-
utilized to assist in establishing substantial equivalence to an
ered by this guide will likely be needed to evaluate a bioactive
existing commercially marketed device. However, these poly-
agent’s composition, loading, release kinetics, safety, and
meric material-oriented guidelines do not necessarily reflect
efficacy.
the total needs for any particular implant application (for
example, orthopedic, cardiovascular, sutures, and dermal
1.8 Composites of absorbable polymers with ceramics
fillers), which may require additional and potentially essential
and/or metals may be evaluated according to many of the
application-specific evaluations.
methods described herein. However, additional test methods
not covered by this guide will likely be needed to evaluate the
1.3 This guide is intended to cover all forms of absorbable
composite’s other component(s).
polymeric components and devices, including solid (for
example, injection-molded) and porous (for example, fibrous)
1.9 The values stated in SI units are to be regarded as
forms. This guide is also intended to cover devices fabricated
standard. No other units of measurement are included in this
from amorphous and/or semi-crystalline absorbable polymer
standard.
systems.
1.10 This standard does not purport to address all of the
1.4 This guide has been generated with principal emphasis safety concerns, if any, associated with its use. It is the
on the evaluation of devices formed from synthetic polymers
responsibility of the user of this standard to establish appro-
that degrade in vivo primarily through hydrolysis (for example, priate safety and health practices and determine the applica-
α-hydroxy-polyesters). Evaluation methods suggested herein
bility of regulatory limitations prior to use.
may or may not be applicable to implants formed from 1.11 This international standard was developed in accor-
materials that, upon implantation, are substantially degraded
dance with internationally recognized principles on standard-
through other mechanisms (for example, enzymatically in- ization established in the Decision on Principles for the
duced degradation).
Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
1.5 This guide references and generally describes various
Barriers to Trade (TBT) Committee.
means to assess absorbable materials, components, and de-
vices. The user needs to refer to specific test methods for
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
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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 -
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