BH GSO ASTM F2475:2023
Bahraini Standard
Current Edition
·
Approved on
05 April 2023
·
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
BH GSO ASTM F2475:2023 Files
English
0 Pages
Current Edition
Reference Language
BH GSO ASTM F2475:2023 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.
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