Norm

ASTM F2097-16

Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

61,51

Over deze norm

Status Definitief
Aantal pagina's 18
Commissie F02.50
Gepubliceerd op 01-04-2016
Taal Engels

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.

Details

ICS-code 11.020
55.020
Nederlandse titel Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
Engelse titel Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

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