ASTM F2097 - 16 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

ASTM F2097 - 16

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

Status : Current   Published : April 2016

Format
PDF

Format
HARDCOPY



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.




Standard NumberASTM F2097 - 16
TitleStandard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
StatusCurrent
Publication Date01 April 2016
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Descriptors Flexible Packaging Materials, Medical Product Packaging, Package Design, Performance Characteristics, Pharmaceutical And Medical Packaging
ICS11.120.99
PublisherASTM
FormatA4
DeliveryYes
Pages18
File Size349 KB
Price£45.00


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