GSO ASTM F2475:2022
Gulf Standard
Current Edition
·
Approved on
12 May 2022
·
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
GSO ASTM F2475:2022 Files
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GSO ASTM F2475:2022 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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