ASTM International - ASTM F2097-01

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

historical
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Organization: ASTM International
Publication Date: 10 October 2001
Status: historical
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:

1.1 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.

1.2 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.

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; the sterilization method to be used; or package performance through sterilization, distribution, and handling.

Document History

May 1, 2020
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
4.1 This design and evaluation guide describes multiple categories for evaluating flexible medical packages and packaging materials. These include safety, barrier, material and package performance...
April 1, 2016
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
4.1 This design and evaluation guide describes multiple categories for evaluating flexible medical packages and packaging materials. These include safety, barrier properties, durability, package and...
April 1, 2014
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
4.1 This design and evaluation guide describes multiple categories for evaluating flexible medical packages and packaging materials. These include safety, barrier properties, durability, package and...
April 1, 2010
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
This design and evaluation guide describes multiple categories for evaluating flexible medical packages and packaging materials. These include safety, barrier properties, durability, package and seal...
May 1, 2008
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
This design and evaluation guide describes seven categories for evaluating flexible medical packages and packaging materials. These include safety, barrier properties, durability, package and seal...
May 1, 2007
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
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...
April 1, 2005
Standard Guide for Design and Evaluation of Primary Packaging for Medical Products
1.1 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...
ASTM F2097-01
October 10, 2001
Standard Guide for Design and Evaluation of Primary Packaging for Medical Products
1.1 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...
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