Designation

This standard is issued under the fixed designation F2097; the number immediately following the designation indicates the year of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript epsilon (ε) indicates an editorial change since the last revision or reapproval.

1. Scope

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.

1.6

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

2. Referenced Documents

2.1

2.2

2.3

2.4

2.5

3. Terminology

3.1 Definitions of Terms Specific to This Standard:

3.2

4. Significance and Use

4.1

4.2

4.3

4.4

4.5

4.6

4.7

ASTM F2097 - 23

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

Published:

1 Oct 2023

Withdrawn:

6 Nov 2025