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About This Item
Full Description
1.1 This guide provides information to determine the appropriate testing for biocompatibility of materials (or packaging materials) in sterile barrier systems used to contain a medical device.
1.2 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 to determine the applicability of regulatory limitations prior to use.
Document History
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ASTM F2475-20
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials- Most Recent
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ASTM F2475-11
viewing
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials- Historical Version
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ASTM F2475-05
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials- Historical Version