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    ASTM D4196 - 05(2019)

    Standard Test Method for Confirming the Sterility of Membrane Filters

    Active Standard ASTM D4196 | Developed by Subcommittee: D19.08

    Book of Standards Volume: 11.02

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    Significance and Use

    5.1 This test method may be employed to check the sterility of commercially procured sterile membrane filters. The test also confirms that sterilized filters have not been contaminated. Additionally, this test may be used to monitor the efficacy of in-house sterilization procedures. Filter packages that have obvious packaging defects should not be tested because sterility may have been compromised.

    1. Scope

    1.1 This test method describes a test to confirm the sterility of either manufacturer presterilized or user-sterilized analytical membrane filters.

    1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

    1.3 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

    1.4 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 (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    D1129 Terminology Relating to Water

    D1193 Specification for Reagent Water

    Other Standard

    The United States Pharmacopeia Current Edition Mack Publishing Co., Easton, PA 18042. (Sections on Sterilization and Sterility Testing)

    ICS Code

    ICS Number Code 11.080.99 (Other standards related to sterilization and disinfection)

    UNSPSC Code

    UNSPSC Code

    Referencing This Standard
    Link Here
    Link to Active (This link will always route to the current Active version of the standard.)

    DOI: 10.1520/D4196-05R19

    Citation Format

    ASTM D4196-05(2019), Standard Test Method for Confirming the Sterility of Membrane Filters, ASTM International, West Conshohocken, PA, 2019, www.astm.org

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