ASTM F1983-14

Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications

SIGNIFICANCE AND USE
4.1 This practice is a guideline for a screening test for the evaluation of the local tissue response to materials that may be selected for implantation into the human body and which are expected to undergo absorption within three years.  
4.2 This practice is similar to that for studies on candidate materials 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.  
4.3 The material to be tested should be in the final finished form as for intended use, including sterilization. Material/body ratios should be relevant to that of intended device use. Material surface area or mass to body mass ratios of 1X, 10X, and 50X if applicable, are recommended.  
4.4 Materials that are designed for use in devices with in situ polymerization shall be introduced in a manner such that in situ polymerization occurs. Testing of individual precursor components is not recommended.
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 will vary depending on chemical composition implant size, implant location, and test subject species; therefore, the implantation times for examination of tissue response will be linked to 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 do not fully assess systemic toxicity, carcinogenicity, teratogenicity, 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 can be addressed with this practice, and these effects should be documented fully.  
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.

General Information

• Status: Historical
• Publication Date: 31-Oct-2014
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.16 - Biocompatibility Test Methods

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F1983 − 14
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 1.5 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
1.1 This practice provides experimental protocols for bio-
responsibility of the user of this standard to establish appro-
logical assays of tissue reactions to absorbable biomaterials for
priate safety and health practices and determine the applica-
implant applications. This practice applies only to absorbable
bility of regulatory limitations prior to use.
materials with projected clinical applications in which the
materials will reside in bone or soft tissue longer than 30 days
2. Referenced Documents
and less than three years. Other standards with designated
2
2.1 ASTM Standards:
implantation times are available to address shorter time peri-
F561 Practice for Retrieval and Analysis of Medical
ods. Careful consideration should be given to the appropriate-
ness of this practice for slowly degrading materials that will Devices, and Associated Tissues and Fluids
F750 Practice for Evaluating Material Extracts by Systemic
remain for longer than three years. It is anticipated that the
tissue response to degrading biomaterials will be different from Injection in the Mouse
F763 Practice for Short-Term Screening of Implant Materi-
the response to nonabsorbable materials. In many cases, a
chronic inflammatory response may be observed during the als
F981 Practice for Assessment of Compatibility of Biomate-
degradation phase, but the local histology should return to
normal after absorption; therefore, the minimal tissue response rials for Surgical Implants with Respect to Effect of
Materials on Muscle and Bone
usually equated with “biocompatibility” may require long
implantations. F1408 Practice for Subcutaneous Screening Test for Implant
Materials
1.2 The time period for implant absorption will vary de-
F1903 Practice for Testing For Biological Responses to
pending on chemical composition implant size, implant
Particles In Vitro
location, and test subject species; therefore, the implantation
F1904 Practice for Testing the Biological Responses to
times for examination of tissue response will be linked to the
Particles in vivo
rate of absorption. No single implantation time is indicated in
F1905 Practice For Selecting Tests for Determining the
this practice.
Propensity of Materials to Cause Immunotoxicity (With-
3
1.3 These protocols assess the effects of the material on the
drawn 2011)
animal tissue in which it is implanted. The experimental
F1906 Practice for Evaluation of Immune Responses In
protocols do not fully assess systemic toxicity, carcinogenicity,
Biocompatibility Testing Using ELISA Tests, Lymphocyte
3
teratogenicity, or mutagenicity of the material. Other standards
Proliferation, and Cell Migration (Withdrawn 2011)
are available to address these issues.
3. Summary of Practice
1.4 To maximize use of the animals in the study protocol, all
toxicological findings should be recorded. There are some
3.1 Under strict aseptic conditions, specimens of the sterile
aspects of systemic toxicity, including effects of degradation
final implant form candidate material are implanted into the
products on the target organs, that can be addressed with this
most relevant anatomical tissue site in small laboratory
practice, and these effects should be documented fully.
animals, preferably mice, rats, hamsters, or rabbits.
1 2
This practice is under the jurisdiction of ASTM CommitteeF04 on Medical and For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Surgical Materials and Devices and is the direct responsibility of Subcommittee contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
F04.16 on Biocompatibility Test Methods. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Nov. 1, 2014. Published January 2015. Originally the ASTM website.
3
approved in 1999. Last previous edition approved in 2008 as F1983 – 99 (2008). The last approved version of this historical standard is referenced on
DOI: 10.1520/F1983-14. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F1983 − 14
3.2 The use of larger animals, such as the dog, goa
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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: F1983 − 99 (Reapproved 2008) F1983 − 14
Standard Practice for
Assessment of Compatibility of Absorbable/
ResorbableSelected 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/resorbableabsorbable
biomaterials for implant applications. This practice applies only to resorbable/absorbableabsorbable 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 the 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 nonresorbablenonabsorbable
materials. In many cases, a chronic inflammatory response may be observed during the degradation phase, but the local histology
should return to normal after degradation;absorption; therefore, the minimal tissue response usually equated with “biocompat-
ibility” may require long implantations.
1.2 The time period for implant degradationabsorption will vary depending on chemical composition and implant size; implant
size, implant location, and test subject species; therefore, the implantation times for examination of tissue response will be linked
to the rate of resorption.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
do not fully assess systemic toxicity, carcinogenicity, teratogenicity, 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 can be addressed with this practice, and
these effects should be documented fully.
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:
F561 Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
F750 Practice for Evaluating Material Extracts by Systemic Injection in the Mouse
F763 Practice for Short-Term Screening of Implant Materials
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
F1408 Practice for Subcutaneous Screening Test for Implant Materials
F1903 Practice for Testing For Biological Responses to Particles In Vitro
F1904 Practice for Testing the Biological Responses to Particles in vivo
1
This practice is under the jurisdiction of ASTM CommitteeF04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.16
on Biocompatibility Test Methods.
Current edition approved Aug. 1, 2008Nov. 1, 2014. Published August 2008January 2015. Originally approved in 1999. Last previous edition approved in 20032008 as
F1983 – 99 (2003).(2008). DOI: 10.1520/F1983-99R08.10.1520/F1983-14.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. 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. United States
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F1983 − 14
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F1905 Practice For Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity (Withdrawn 2011)
F1906 Practice for Evaluation of Immune Responses In Biocompati
...