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ASTM F2475-11 + Redline

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ASTM F2475-11 + Redline

Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials

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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.
Significance and Use:

Author ASTM
Editor ASTM
Document type Standard
Format File
ICS 11.120.99 : Other standards related to pharmaceutics
55.020 : Packaging and distribution of goods in general
Number of pages 4
Replace ASTM F2475-05 + Redline
Set ASTMVOL1510
Year 2011
Document history ASTM F2475-05 + Redline
Country USA
Keyword ASTM 2475;ASTM F2475;ASTM F2475;10.1520/F2475-11