ASTM F 2097 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
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ASTM F 2097 Document Information:
Title
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
ASTM International
Publication Date:
May 1, 2008
Scope:
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.
This guide provides a compendium of test methods. 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.
This guide does not address acceptability criteria, which need
to be determined jointly by the package producer and the medical
products manufacturer.
This guide does not assess the product to be packaged; the
sterilization method to be used; or package performance through
sterilization, distribution, and handling.
The values stated in SI units are to be regarded as standard.
The values given in parentheses are mathematical conversions to
inch-pound units that are provided for information only and are not
considered standard.
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