The ASTM F 2097-23 Standard Guide provides a framework for the design and evaluation of primary flexible Encasement for medical products. It covers multiple aspects of Encasement material safety, barrier performance, Encasement integrity, visibility, Printing ink, and conditioning. The purpose of the guide is to assist in the evaluation and selection of applicable Encasement design requirements and to determine appropriate testing methods to ensure Encasement conforms to specifications. While many of the standards in the guide are recognized by the U.S. FDA, the application of these standards is voluntary. The guide does not address the evaluation of acceptability standards, the product itself, or sterilized methods.
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| CCS | ICS |
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