• AAMI ISO 11137 : 94 AMD 1 2002

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - REQUIREMENTS FOR THE VALIDATION AND ROUTINE CONTROL - RADIATION STERILIZATION

    Available format(s): 

    Superseded date:  05-30-2006

    Language(s): 

    Published date:  11-23-2012

    Publisher:  Association for the Advancement of Medical Instrumentation

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    Abstract - (Show below) - (Hide below)

    Provides requirements for validation, process control and routine monitoring for radiation sterilization of health care products.

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    Committee WG 02
    Development Note Together with AAMI ISO TIR 13409, supersedes AAMI ST32. Supersedes AAMI ST31 and AAMI TIR5. (07/2002)
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    ANSI Z80.7 : 2013 OPHTHALMIC OPTICS - INTRAOCULAR LENSES
    AAMI AT6 : 2013 AUTOLOGOUS TRANSFUSION DEVICES
    AAMI ISO TIR 13409 : 1996 ERRATA 2005 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - SUBSTANTIATION OF 25 KGY AS A STERILIZATION DOSE FOR SMALL OR INFREQUENT PRODUCTION BATCHES
    ASTM F 2051 : 2000 : R2006 Standard Specification for Implantable Saline Filled Breast Prosthesis
    ASTM F 2051 : 2000 Standard Specification for Implantable Saline Filled Breast Prosthesis
    ASTM F 2051 : 2000 : R2014 Standard Specification for Implantable Saline Filled Breast Prosthesis
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