ASTM F1983-23
(Practice)Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
SIGNIFICANCE AND USE
5.1 This practice is a guideline for a screening test of candidate materials or assessment of local tissue response to absorbable medical devices which are expected to undergo complete absorption within three years.
5.2 This practice is similar to those for studies on candidate materials or medical devices that are not absorbable, such as those specified in Practices F763, F981, and F1408; however, analysis of the host response must take into account the effect of degradation and degradation products on the inflammatory response at the local tissue site and on subsequent healing of the implantation site, as well as the potential for adverse distal tissue effects.
5.3 For testing of absorbable medical devices, the test article for implantation should be in the final finished form as for intended use, including packaging and sterilization (if applicable). Configurations specific to the animal study may be needed. The test article’s surface-area-to-body mass or mass-to-body mass ratios within the animal model should be established by calculating based on surface-area-to-body mass or mass-to-body mass ratios in humans during the device’s intended clinical use. Worst-case clinical dose should be considered in the study design. For implantation studies incorporating evaluation of both local tissue responses and systemic toxicity, exaggerated material surface area or mass-to-body mass ratios (for example, a 2X to 10X safety factor to assess implant safety for regulatory submissions) compared to clinical use (for example, largest device size, maximum number of devices) should be considered, unless otherwise justified. For example, implantation of exaggerated doses may not be feasible in the selected animal model. For some devices, additional animal group(s) for exaggerated conditions should be considered if dose response information is needed. Additionally, for some devices, exaggerated dose at a specific implantation site can also be used to evaluate local tissue res...
SCOPE
1.1 This practice provides experimental protocols for biological assays of tissue reactions to absorbable biomaterials for implant applications. This practice applies only to absorbable materials with projected clinical applications in which the materials will reside in bone or soft tissue longer than 30 days and less than three years. Other standards with designated implantation times are available to address shorter time periods. Careful consideration should be given to the appropriateness of this practice for slowly degrading materials that will remain for longer than three years. It is anticipated that the tissue response to degrading biomaterials will be different from the response to nonabsorbable materials. In many cases, a chronic inflammatory response may be observed during the degradation phase, but the local histology should return to normal after absorption; therefore, the minimal tissue response usually equated with biocompatibility may require long implantations.
1.2 The time period for implant absorption can depend on variables of chemical composition, implant size, implant location, and animal models. Therefore, the selected time points for assessing tissue effects may be selected based on the rate of absorption.
1.3 These protocols assess the effects of the material on the animal tissue in which it is implanted. They do not fully assess systemic toxicity, carcinogenicity, reproductive and development toxicity, or mutagenicity of the material. Other standards are available to address these issues.
1.4 To maximize use of the animals in the study protocol, some aspects of systemic toxicity, including effects of degradation products on different organs and tissues downstream of or surrounding the target site, can be addressed with this practice.
1.5 Because animal models are not identical to human biology, this practice cannot account for all potential biological hazards, for example the effect o...
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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: F1983 − 23
Standard Practice for
Assessment of Selected Tissue Effects of Absorbable
1
Biomaterials for Implant Applications
This standard is issued under the fixed designation F1983; 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 hazards, for example the effect of the oligosaccharide a-Gal
(Gala 1,3-Galb1-4GlcNAc-R), known as the “a-Gal” epitope
1.1 This practice provides experimental protocols for bio-
present in xenogeneic materials on humans. See ISO 22442.
logical assays of tissue reactions to absorbable biomaterials for
1.6 This standard does not purport to address all of the
implant applications. This practice applies only to absorbable
safety concerns, if any, associated with its use. It is the
materials with projected clinical applications in which the
responsibility of the user of this standard to establish appro-
materials will reside in bone or soft tissue longer than 30 days
priate safety, health, and environmental practices and deter-
and less than three years. Other standards with designated
mine the applicability of regulatory limitations prior to use.
implantation times are available to address shorter time peri-
1.7 This international standard was developed in accor-
ods. Careful consideration should be given to the appropriate-
dance with internationally recognized principles on standard-
ness of this practice for slowly degrading materials that will
ization established in the Decision on Principles for the
remain for longer than three years. It is anticipated that the
Development of International Standards, Guides and Recom-
tissue response to degrading biomaterials will be different from
mendations issued by the World Trade Organization Technical
the response to nonabsorbable materials. In many cases, a
Barriers to Trade (TBT) Committee.
chronic inflammatory response may be observed during the
degradation phase, but the local histology should return to
2. Referenced Documents
normal after absorption; therefore, the minimal tissue response
2
usually equated with biocompatibility may require long im-
2.1 ASTM Standards:
plantations.
F561 Practice for Retrieval and Analysis of Medical
Devices, and Associated Tissues and Fluids
1.2 The time period for implant absorption can depend on
F763 Practice for Short-Term Intramuscular Screening of
variables of chemical composition, implant size, implant
Implantable Medical Device Materials
location, and animal models. Therefore, the selected time
F981 Practice for Assessment of Compatibility of Biomate-
points for assessing tissue effects may be selected based on the
rials for Surgical Implants with Respect to Effect of
rate of absorption.
Materials on Muscle and Insertion into Bone
1.3 These protocols assess the effects of the material on the
F1408 Practice for Subcutaneous Screening Test for Implant
animal tissue in which it is implanted. They do not fully assess
Materials
systemic toxicity, carcinogenicity, reproductive and develop-
F1635 Test Method for in vitro Degradation Testing of
ment toxicity, or mutagenicity of the material. Other standards
Hydrolytically Degradable Polymer Resins and Fabricated
are available to address these issues.
Forms for Surgical Implants
1.4 To maximize use of the animals in the study protocol,
F1903 Practice for Testing for Cellular Responses to Par-
some aspects of systemic toxicity, including effects of degra-
ticles in vitro
dation products on different organs and tissues downstream of
F1904 Practice for Testing the Biological Responses to
or surrounding the target site, can be addressed with this
Particles in vivo
practice.
F2902 Guide for Assessment of Absorbable Polymeric Im-
plants
1.5 Because animal models are not identical to human
F3268 Guide for in vitro Degradation Testing of Absorbable
biology, this practice cannot account for all potential biological
Metals
1
This practice is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
2
F04.16 on Biocompatibility Test Methods. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved April 1, 2023. Published April 2023. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 1999. Last previous edition approved in 2014 as F1983 – 14. DOI: Standards volume information, refer to the standard’s Document Summary
...
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: F1983 − 14 F1983 − 23
Standard Practice for
Assessment of Selected Tissue Effects of Absorbable
1
Biomaterials for Implant Applications
This standard is issued under the fixed designation F1983; 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 practice provides experimental protocols for biological assays of tissue reactions to absorbable biomaterials for implant
applications. This practice applies only to absorbable materials with projected clinical applications in which the materials will
reside in bone or soft tissue longer than 30 days and less than three years. Other standards with designated implantation times are
available to address shorter time periods. Careful consideration should be given to the appropriateness of this practice for slowly
degrading materials that will remain for longer than three years. It is anticipated that the tissue response to degrading biomaterials
will be different from the response to nonabsorbable materials. In many cases, a chronic inflammatory response may be observed
during the degradation phase, but the local histology should return to normal after absorption; therefore, the minimal tissue
response usually equated with “biocompatibility”biocompatibility may require long implantations.
1.2 The time period for implant absorption will vary depending on chemical compositioncan depend on variables of chemical
composition, implant size, implant location, and test subject species; therefore, the implantation times for examination of tissue
response will be linked to animal models. Therefore, the selected time points for assessing tissue effects may be selected based
on the rate of absorption. No single implantation time is indicated in this practice.
1.3 These protocols assess the effects of the material on the animal tissue in which it is implanted. The experimental protocols
They do not fully assess systemic toxicity, carcinogenicity, teratogenicity, reproductive and development toxicity, or mutagenicity
of the material. Other standards are available to address these issues.
1.4 To maximize use of the animals in the study protocol, all toxicological findings should be recorded. There are some aspects
of systemic toxicity, including effects of degradation products on the target organs, that different organs and tissues downstream
of or surrounding the target site, can be addressed with this practice, and these effects should be documented fully. practice.
1.5 Because animal models are not identical to human biology, this practice cannot account for all potential biological hazards,
for example the effect of the oligosaccharide a-Gal (Gala 1,3-Galb1-4GlcNAc-R), known as the “a-Gal” epitope present in
xenogeneic materials on humans. See ISO 22442.
1.6 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 healthsafety, health, and environmental practices and determine
the applicability of regulatory limitations prior to use.
1.7 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.
1
This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.16
on Biocompatibility Test Methods.
Current edition approved Nov. 1, 2014April 1, 2023. Published January 2015April 2023. Originally approved in 1999. Last previous edition approved in 20082014 as
F1983 – 99 (2008).F1983 – 14. DOI: 10.1520/F1983-14.10.1520/F1983-23.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F1983 − 23
2. Referenced Documents
2
2.1 ASTM Standards:
F561 Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
F750 Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse
F763 Practice for Short-Term Intramus
...
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