ASTM International - ASTM F2475-20

Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials

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Organization: ASTM International
Publication Date: 1 January 2020
Status: active
Page Count: 3
ICS Code (Other standards related to pharmaceutics): 11.120.99
ICS Code (Packaging and distribution of goods in general): 55.020
significance And Use:

5.1 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,... View More

scope:

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 indirectly.

1.2 This guide does not apply to secondary or tertiary packaging materials.

1.3 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Document History

ASTM F2475-20
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...
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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