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    I.S. EN ISO 11737-1:2018&LC:2018

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS (ISO 11737-1:2018)

    Available format(s):  Hardcopy, PDF

    Superseded date:  21-07-2021

    Language(s):  English

    Published date:  01-01-2018

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    National Foreword
    European foreword
    Endorsement notice
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Selection of products
    6 Methods of determination and microbial characterization of
      bioburden
    7 Validation of the method for determining bioburden
    8 Routine determination of bioburden and interpretation of
      data
    9 Maintenance of the method for determining bioburden
    Annex A (informative) - Guidance on the determination of
            a population of microorganisms on products
    Annex B (informative) - Guidance on methods to determine
            bioburden
    Annex C (informative) - Validation of bioburden recovery efficiency
    Annex D (informative) - Typical assignment of responsibilities
    Bibliography
    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

    Abstract - (Show below) - (Hide below)

    Gives requirements and provides guidance for the enumeration and microbial characterization of the population of viable micro-organisms on or in a medical device, component, raw material or package.

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

    Committee TC 198
    Development Note Supersedes I.S. EN 1174-1, I.S. EN 1174-2 and I.S. EN 1174-3. (06/2006) 2018 Edition incorporates corrigenda issued on 18-04-2018, 10-04-2018 & 04-04-2018. (05/2018)
    Document Type Standard
    Product Note LATEST CORRECTION IS NOW AVAILABLE FOR THIS STANDARD The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document
    Publisher National Standards Authority of Ireland
    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
    AAMI TIR37 : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - GUIDANCE ON STERILIZATION OF BIOLOGICS AND TISSUE-BASED PRODUCTS
    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 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the 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 15189:2012 Medical laboratories — Requirements for quality and competence
    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 13022:2012 Medical products containing viable human cells — Application of risk management and requirements for processing practices
    ISO 20857:2010 Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
    ISO 9001:2015 Quality management systems — Requirements
    ISO 7870-4:2011 Control charts Part 4: Cumulative sum charts
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
    ISO/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software
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