ASTM F1408-20
(Practice)Standard Practice for Subcutaneous Screening Test for Implant Materials
Standard Practice for Subcutaneous Screening Test for Implant Materials
SIGNIFICANCE AND USE
4.1 This practice is a guideline for a short-term screening test for the evaluation of the tissue response to materials that may be selected for implantation in the human body and should be done in accordance with good laboratory practices. This test may be performed prior to long-term testing (for example, Practice F981) to eliminate unsuitable candidate materials early and to avoid unnecessary animal testing.
4.2 This practice may be used to detect toxic effects of materials in general (see Appendix X1). However, it is particularly suitable for the testing of materials that are intended to have contact with subcutaneous tissues or soft tissues in general. For materials intended to be inserted specifically into muscle tissues, Practice F763 should be considered as a short-term test method.
4.3 The suggested implant specimens are cylindrical. A special grooved type of cylinder may be used (see Fig. X2.1 of Appendix X2) to allow tissue interlocking that could keep the implant in place and minimize tissue irritation through motion at the interface that otherwise could contribute to increased variance of the results. In case ungrooved cylinders are used (see Fig. X1.2 of Appendix X2), probable motion at the implant/tissue interface must be taken into account. Control cylinders should be shaped like the test cylinders.
4.4 The type of surface preparation of the specimens can affect the tissue reaction; therefore the preparation procedure should be noted in the report. The test may be used to compare the effect of different surface structures or conditions of the same material or to assess the effect of various treatments of modifications of a material.
Note 1: If this method is used for material research, testing for endotoxin prior to implantation should be considered.
SCOPE
1.1 This practice covers a short-term testing method to screen the subcutaneous tissue reaction to implant candidate materials in small laboratory animals. The material may be dense or porous. This method may not work for absorbable materials, depending on the absorption kinetics. The tissue reactions will be evaluated in comparison to those evoked by control materials that are accepted as clinical implant materials.
1.2 This practice, along with other appropriate biological tests (including other ASTM test methods), may be used to assess the biocompatibility of candidate materials for use in the fabrication of devices for clinical application. It may be also applied to evaluate the effect of special surface textures and preparations of known materials.
1.3 This practice does not provide a comprehensive assessment of the systemic toxicity, carcinogenicity, teratogenicity, or mutagenicity of the material. Additional information may be needed on the material in its final finished form, such as implantation assessment at the clinically relevant location.
1.4 The values stated in SI units, including units officially accepted for use with SI, are to be regarded as standard. No other systems of measurement are included in this standard.
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 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: F1408 − 20
Standard Practice for
1
Subcutaneous Screening Test for Implant Materials
This standard is issued under the fixed designation F1408; 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 2. Referenced Documents
2
2.1 ASTM Standards:
1.1 This practice covers a short-term testing method to
F67 Specification for Unalloyed Titanium, for Surgical Im-
screen the subcutaneous tissue reaction to implant candidate
plant Applications (UNS R50250, UNS R50400, UNS
materials in small laboratory animals. The material may be
R50550, UNS R50700)
dense or porous. This method may not work for absorbable
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
materials, depending on the absorption kinetics. The tissue
Alloy Castings and Casting Alloy for Surgical Implants
reactions will be evaluated in comparison to those evoked by
(UNS R30075)
control materials that are accepted as clinical implant materi-
F86 Practice for Surface Preparation and Marking of Metal-
als.
lic Surgical Implants
1.2 This practice, along with other appropriate biological
F136 Specification for Wrought Titanium-6Aluminum-
tests (including other ASTM test methods), may be used to
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
assessthebiocompatibilityofcandidatematerialsforuseinthe
Implant Applications (UNS R56401)
fabrication of devices for clinical application. It may be also
F138 Specification for Wrought 18Chromium-14Nickel-
applied to evaluate the effect of special surface textures and
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
preparations of known materials.
Implants (UNS S31673)
F648 Specification for Ultra-High-Molecular-Weight Poly-
1.3 This practice does not provide a comprehensive assess-
ethylene Powder and Fabricated Form for Surgical Im-
mentofthesystemictoxicity,carcinogenicity,teratogenicity,or
plants
mutagenicity of the material. Additional information may be
F763 Practice for Short-Term Screening of Implant Materi-
needed on the material in its final finished form, such as
als
implantation assessment at the clinically relevant location.
F981 Practice for Assessment of Compatibility of Biomate-
1.4 The values stated in SI units, including units officially rials for Surgical Implants with Respect to Effect of
accepted for use with SI, are to be regarded as standard. No Materials on Muscle and Insertion into Bone
3
other systems of measurement are included in this standard.
2.2 ISO Standard:
ISO 10993-6:2016 Biological Evaluation of Medical
1.5 This standard does not purport to address all of the
Devices—Part 6: Tests for Local Effects After Implanta-
safety concerns, if any, associated with its use. It is the
tion
responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
3. Summary of Practice
mine the applicability of regulatory limitations prior to use.
3.1 Under strict aseptic conditions, test or control samples
1.6 This international standard was developed in accor-
are implanted subcutaneously along the dorsal midline at the
dance with internationally recognized principles on standard-
level of the cervical or thoracic vertebra of an anesthetized
ization established in the Decision on Principles for the
animal. The size of the implant should not impede the normal
Development of International Standards, Guides and Recom-
movement of the animal. After one, four, and nine to twelve
mendations issued by the World Trade Organization Technical
weeks the animals are euthanized, and a comprehensive
Barriers to Trade (TBT) Committee.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Surgical Materials and Devices and is the direct responsibility of Subcommittee Standards volume information, refer to the standard’s Document Summary page on
F04.16 on Biocompatibility Test Methods. the ASTM website.
3
Current edition approved June 1, 2020. Published August 2020. Originally Available from International Organization for Standardization (ISO), ISO
approved in 1992. Last previous edition approved in 2013 as F1408 – 97 (2013). Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,
DOI: 10.1520/F1408-20. Geneva, Switzerland, http://www.iso.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F1408 − 20
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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: F1408 − 97 (Reapproved 2013) F1408 − 20
Standard Practice for
1
Subcutaneous Screening Test for Implant Materials
This standard is issued under the fixed designation F1408; 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 covers a short-term testing method to screen the subcutaneous tissue reaction to metallic or other implant
candidate materials in small laboratory animals. The material may be dense or porous. This method may not work for absorbable
materials, depending on the absorption kinetics. The tissue reactions will be evaluated in comparison to those evoked by control
materials that are accepted as clinical implant materials.
1.2 This practice, along with other appropriate biological tests (including other ASTM test methods), may be used to assess the
biocompatibility of candidate materials for use in the fabrication of devices for clinical application. It may be also applied to
evaluate the effect of special surface textures and preparations of known materials.
1.3 This experimental protocol is not designed to practice does not provide a comprehensive assessment of the systemic toxicity,
carcinogenicity, teratogenicity, or mutagenicity of the material. Additional information may be needed on the material in its final
finished form, such as implantation assessment at the clinically relevant location.
1.4 The values stated in SI units units, including units officially accepted for use with SI, are to be regarded as standard. No other
unitssystems of measurement are included in this standard.
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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.6 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.
2. Referenced Documents
2
2.1 ASTM Standards:
F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS
R50700)
F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS
R30075)
F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
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 Oct. 1, 2013June 1, 2020. Published October 2013August 2020. Originally approved in 1992. Last previous edition approved in 20082013 as
F1408 - 97 (2008).F1408 – 97 (2013). DOI: 10.1520/F1408-97R13.10.1520/F1408-20.
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. United States
1
---------------------- Page: 1 ----------------------
F1408 − 20
F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant
Applications (UNS R56401)
F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)
F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
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 Insertion into Bone
3
2.2 ISO Standard:
ISO 10993-6:2016 Biological Evaluation of Medical Devices—Part 6: Tests for Local Effects After Implantation
3. Summary of Practice
3.1 Under strict aseptic conditions, specimens of the candidate and control materialstest or control samples are
...
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