ASTM F 2475 : 2020
Current
The latest, up-to-date edition.
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
Hardcopy , PDF
English
01-02-2020
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
F 02
|
| DocumentType |
Guide
|
| Pages |
3
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Current
|
| Supersedes |
1.1This 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.
1.2This guide does not apply to secondary or tertiary packaging materials.
1.3This 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.
1.4This 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.
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| ASTM F 2097 : 2016 | Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
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