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ASTM International - ASTM F2475-05

Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials

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Organization: ASTM International
Publication Date: 1 April 2005
Status: inactive
Page Count: 4
ICS Code (Other standards related to pharmaceutics): 11.120.99
ICS Code (Packaging and distribution of goods in general): 55.020
significance And Use:

The compatibility of packaging materials with a medical device is a requirement of many regulatory bodies. Since most medical devices are used or implanted in, around or on the human body, these... View More

scope:

1.1 This guide provides information to determine the appropriate testing for biocompatibility of packaging materials 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

January 1, 2020
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
1.1 This guide provides information to determine the appropriate testing for biocompatibility of medical device packaging materials that have the potential to contact the patient directly or...
April 1, 2011
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
The compatibility of packaging materials with a medical device is a requirement of many regulatory bodies. Since most medical devices are used or implanted in, around or on the human body, these...
ASTM F2475-05
April 1, 2005
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
The compatibility of packaging materials with a medical device is a requirement of many regulatory bodies. Since most medical devices are used or implanted in, around or on the human body, these...
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