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  • AAMI ISO TIR 15843 : 2000

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - PRODUCT FAMILIES AND SAMPLING PLANS FOR VERIFICATION DOSE EXPERIMENTS AND STERILIZATION DOSE AUDITS, AND FREQUENCY OF STERILIZATION DOSE AUDITS

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    Superseded date:  16-01-2007

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    Published date:  23-11-2012

    Publisher:  Association for the Advancement of Medical Instrumentation

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    Abstract - (Show below) - (Hide below)

    Gives three approaches that the primary manufacturer can use to reduce the total number of product units tested to establish and audit the radiation sterilization dose while maintaining assurance that the designated sterility assurance level (SAL) is achieved.

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    Committee WG 02
    Development Note To be used in conjunction with AAMI ISO 11137 (07/2002) Supersedes AAMI ST31, AAMI ST32 and AAMI TIR5. (04/2004)
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By
    Supersedes
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