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  • 99/562423 DC : DRAFT APR 99

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BS:ENISO 14937 - STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL CRITERIA FOR CHARACTERIZATION OF A STERILIZING AGENT AND DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS

    Available format(s): 

    Superseded date:  15-03-2001

    Language(s): 

    Published date:  23-11-2012

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    1 Scope
    2 Normative references
    3 Definitions
    4 Quality System
    5 Sterilizing agent characterization
    6 Process and equipment characterization
    7 Product definition
    8 Process definition
    9 Validation
    10 Routine monitoring and control
    11 Product release from sterilization
    12 Maintaining process effectiveness

    General Product Information - (Show below) - (Hide below)

    Comment Closes On
    Committee CH/67
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 13488:1996 Quality systems — Medical devices — Particular requirements for the application of ISO 9002
    ISO 11737-2:2009 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
    ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
    ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
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