ASTM F 2475 : 2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
Hardcopy , PDF
06-04-2020
English
01-04-2011
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.
Committee |
F 02
|
DocumentType |
Guide
|
Pages |
4
|
PublisherName |
American Society for Testing and Materials
|
Status |
Superseded
|
SupersededBy | |
Supersedes |
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.
ASTM F 2097 : 2016 | Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
ASTM F 99 : 2007 : R2015 | Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials |
ASTM F 2559/F2559M : 2006 : R2015 | Standard Guide for Writing a Specification for Sterilizable Peel Pouches |
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