GSO ASTM F2097:2022
Gulf Standard
Current Edition
·
Approved on
12 May 2022
·
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
GSO ASTM F2097:2022 Files
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GSO ASTM F2097:2022 Scope
1.1 This guide provides directions for the design and evaluation of primary flexible packages for medical products. The
package materials must be selected appropriately for manufacturing process, end use, and the product being packaged.
1.2 This guide provides a compendium of test methods,
practices, and procedures. Specific individual test methods
must be selected based on the pertinent characteristics of the
specific product to be packaged and the purpose for testing,
research and development, or compliance. Not all test methods
will be applicable.
1.3 This guide does not address acceptability criteria, which
need to be determined jointly by the package producer and the
medical products manufacturer.
1.4 This guide does not assess the product to be packaged or
the sterilization method to be used.
1.5 The units cited in the referenced standard should be
used.
1.6 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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