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  • 16/30302485 DC : 0

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 11737-1 - STERILIZATION OF HEALTH CARE PRODUCTS - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCT

    Available format(s):  Hardcopy, PDF

    Superseded date:  21-02-2018

    Language(s):  English

    Published date: 

    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
    5 Selection of product
    6 Methods of determination and microbial
      characterization of bioburden
    7 Validation of method for determining
      bioburden
    8 Routine determination of bioburden and
      interpretation of data
    9 Maintenance of the method of determination
      of bioburden
    Annex A (informative) - Guidance on determination
            of a population of microorganisms on product
    Annex B (informative) - Guidance on methods of
            determination of bioburden
    Annex C (informative) - Validation of bioburden
            recovery efficiency
    Annex D (informative) - Typical assignment of responsibilities
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential Requirements of
             EU Directive 90/385/EEC on active implantable medical
             devices
    Annex ZB (informative) - Relationship between this European
             Standard and the Essential Requirements of EU Directive
             93/42/EEC on medical devices
    Annex ZC (informative) - Relationship between this European
             Standard and the Essential Requirements of EU Directive
             98/79/EC on in vitro diagnostic medical devices
    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    Status Superseded
    Superseded By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 11737-2:2009 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
    ISO 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/TS 11139:2006 Sterilization of health care products Vocabulary
    ISO 11137-3:2017 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
    ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software
    ISO/TR 7871:1997 Cumulative sum charts Guidance on quality control and data analysis using CUSUM techniques
    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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