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  • 07/30157769 DC : DRAFT DEC 2007

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 EN ISO 11737-2 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE VALIDATION OF A STERILIZATION PROCESS

    Available format(s): 

    Superseded date:  31-03-2010

    Language(s): 

    Published date:  23-11-2012

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Quality management system elements
      4.1 Documentation
      4.2 Management responsibility
      4.3 Product realization
      4.4 Measurement, analysis and improvement
    5 Selection of product
      5.1 General
      5.2 Sample item portion (SIP)
      5.3 Packaging of product and Sample Item Portions
    6 Methods for performing tests of sterility
    7 Assessment of method for performing tests of sterility
    8 Maintenance of the method for performing tests of sterility
    Annex A (informative) Guidance on tests of sterility performed
                          in validation of a sterilization process
          A.1 Scope
          A.2 Normative references
          A.3 Definitions
          A.4 Quality management system elements
              A.4.1 Documentation
              A.4.2 Management responsibility
              A.4.3 Product realization
              A.4.4 Measurement, analysis and improvement
          A.5 Selection of product
              A.5.1 General
              A.5.2 Sample Item Portion (SIP)
              A.5.3 Packaging of product and Sample Item Portions
          A.6 Methods for performing tests of sterility
          A.7 Assessment of method for performing tests of sterility
          A.8 Maintenance of the method for performing tests of
              sterility
    Bibliography

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

    Comment Closes On
    Committee CH/198
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 14160:2011 Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
    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 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    ISO 11138-2:2017 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
    ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    ISO/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software
    ISO 10012-1:1992 Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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