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Significance and Use
3.1 This material challenge is presented in ISO-11607-1 Annex C as a normative test method to demonstrate that a material is nonporous and satisfies the microbial barrier requirements.
1.1 This test method is to be used to verify a specific material design property. Some flexible barrier materials are designed to have a resistance to the passage of air through the membrane structure. These materials are characterized as nonporous. This test method provides a means to verify this property by challenging a material with a given volume of air under pressure over a specific time period.
1.2 This test method is not intended to measure the diffusion properties of a material nor to identify or quantify the presence of pinhole damage to the design that may result in leaks.
1.3 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
E171 Practice for Conditioning and Testing Flexible Barrier Packaging
ISO StandardsISO 11607-1 Packaging for Terminally Sterilized Medical Devices--Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems ISO 5636-5 Paper and Board--Determination of Air Permeance and Air Resistance (Medium Range)--Part 5: Gurley Method
ICS Number Code 11.080.30 (Sterilized packages)
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM F2981-15, Standard Test Method for Verifying Nonporous Flexible Barrier Material Resistance to the Passage of Air, ASTM International, West Conshohocken, PA, 2015, www.astm.orgBack to Top