ASTM F748-04
(Practice)Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
SCOPE
1.1 This practice recommends generic biological test methods for materials and devices according to end-use applications. While chemical testing for extractable additives and residual monomers or residues from processing aids is necessary for most implant materials, such testing is not included as part of this practice. The reader is cautioned that the area of materials biocompatibility testing is a rapidly evolving field, and improved methods are evolving rapidly, so this practice is by necessity only a guideline. A thorough knowledge of current techniques and research is critical to a complete evaluation of new materials.
1.2 These test protocols are intended to apply to materials and medical devices for human application. Biological evaluation of materials and devices, and related subjects such as pyrogen testing, batch testing of production lots, and so on, are also discussed. Tests include those performed on materials, end products, and extracts. Rationale and comments on current state of the art are included for all test procedures described.
1.3 The biocompatibility of materials used in single or multicomponent medical devices for human use depends to a large degree on the particular nature of the end-use application. Biological reactions that are detrimental to the success of a material in one device application may have little or no bearing on the successful use of the material for a different application. It is, therefore, not possible to specify a set of biocompatibility test methods which will be necessary and sufficient to establish biocompatibility for all materials and applications.
1.4 The ethical use of research animals places the obligation on the individual investigator to determine the most efficient methods for performing the necessary testing without undue use of animals. Where adequate prior data exists to substantiate certain types of safety information, these guidelines should not be interpreted to mean that testing should be unnecessarily repeated.
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.
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Designation:F748–04
Standard Practice for
Selecting Generic Biological Test Methods for Materials and
1
Devices
This standard is issued under the fixed designation F 748; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
1.1 This practice recommends generic biological test meth-
bility of regulatory limitations prior to use.
ods for materials and devices according to end-use applica-
tions. While chemical testing for extractable additives and
2. Referenced Documents
residual monomers or residues from processing aids is neces-
2
2.1 ASTM Standards:
sary for most implant materials, such testing is not included as
E 1202 Guide for Development of Micronucleus Assay
part of this practice. The reader is cautioned that the area of
Standards
materials biocompatibility testing is a rapidly evolving field,
E 1262 Guide for Performance of the Chinese Hamster
and improved methods are evolving rapidly, so this practice is
Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Trans-
bynecessityonlyaguideline.Athoroughknowledgeofcurrent
ferase Gene Mutation Assay
techniques and research is critical to a complete evaluation of
E 1263 Guide for Conduct of Micronucleus Assays in
new materials.
Mammalian Bone Marrow Erythrocytes
1.2 These test protocols are intended to apply to materials
E 1280 Guide for Performing the Mouse Lymphoma Assay
and medical devices for human application. Biological evalu-
for Mammalian Cell Mutagenicity
ation of materials and devices, and related subjects such as
E 1397 PracticefortheinvitroRatHepatocyteDNARepair
pyrogen testing, batch testing of production lots, and so on, are
Assay
alsodiscussed.Testsincludethoseperformedonmaterials,end
E 1398 Practice for the in vivo Rat Hepatocyte DNARepair
products, and extracts. Rationale and comments on current
Assay
state of the art are included for all test procedures described.
F 619 Practice for Extraction of Medical Plastics
1.3 The biocompatibility of materials used in single or
F 719 Practice for Testing Biomaterials in Rabbits for
multicomponent medical devices for human use depends to a
Primary Skin Irritation
largedegreeontheparticularnatureoftheend-useapplication.
F 720 Practice for Testing Guinea Pigs for Contact Aller-
Biological reactions that are detrimental to the success of a
gens: Guinea Pig Maximization Test
materialinonedeviceapplicationmayhavelittleornobearing
F 749 Practice for Evaluating Material Extracts by Intracu-
on the successful use of the material for a different application.
taneous Injection in the Rabbit
It is, therefore, not possible to specify a set of biocompatibility
F 750 Practic for Evaluating Material Extracts by Systemic
test methods which will be necessary and sufficient to establish
Injection in the Mouse
biocompatibility for all materials and applications.
F 756 Practice for Assessment of the Hemolytic Properties
1.4 Theethicaluseofresearchanimalsplacestheobligation
of Materials
on the individual investigator to determine the most efficient
F 763 Practice for Short-Term Screening of Implant Mate-
methods for performing the necessary testing without undue
rials
useofanimals.Whereadequatepriordataexiststosubstantiate
F 813 PracticeforDirectContactCellCultureEvaluationof
certain types of safety information, these guidelines should not
Materials for Medical Devices
be interpreted to mean that testing should be unnecessarily
F 895 Test Method forAgar Diffusion Cell Culture Screen-
repeated.
ing for Cytotoxicity
1.5 This standard does not purport to address all of the
F 981 Practice for Assessment of Compatibility of Bioma-
safety concerns, if any, associated with its use. It is the
terials for Surgical Implants with Respect to Effect of
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ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
2
Surgical Materials and Devices and is direct responsibility of Subcommittee F04.16 For referenced ASTM standards, visit the ASTM website, www.astm.org, or
on Biocompatibility Test Methods. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved May 1, 2004. Published June 2004. Originally Standards volume information, refer to the standard’s Document Summary page on
approved in 1982. Last previous edition approved in 1998 as F 748 – 98. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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F748–04
Materials
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