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ASTM F2097

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

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Organization: ASTM
Publication Date: 10 October 2001
Status: inactive
Page Count: 11
ICS Code (Medical sciences and health care facilities in general): 11.020
ICS Code (Packaging and distribution of goods in general): 55.020
scope:

Scope

This guide provides directions for the design and evaluation of primary 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.

Document History

September 1, 2020
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
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...
April 1, 2016
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
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...
April 1, 2014
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
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...
April 1, 2010
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
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...
May 1, 2008
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
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...
May 1, 2007
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
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...
April 1, 2005
Standard Guide for Design and Evaluation of Primary Packaging for Medical Products
This guide provides directions for the design and evaluation of primary packages for medical products. The package materials must be selected appropriately for manufacturing process, end use, and the...
ASTM F2097
October 10, 2001
Standard Guide for Design and Evaluation of Primary Packaging for Medical Products
Scope This guide provides directions for the design and evaluation of primary packages for medical products. The package materials must be selected appropriately for manufacturing process, end use,...

References

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