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    I.S. EN ISO 15883-7:2016

    Current The latest, up-to-date edition.

    WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2016

    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
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Performance requirements
    5 Mechanical requirements
    6 Testing for conformity
    7 Documentation
    8 Information to be provided by the manufacturer
    9 Marking, labelling, and packaging
    10 Information to be requested from the purchaser
       by the manufacturer
    Annex A (normative) - Summary of test programmes
    Annex B (normative) - Methods for microbiological
            evaluation of disinfection of liquid transport system
    Annex C (normative) - Tests for microbiological
            contamination of post-disinfection rinse water
    Annex D (normative) - Preparation and evaluation of
            indicators for microbiological testing of the efficacy
            of chemical disinfection of the load
    Annex E (informative) - Examples of test locations for the
            tests with biological indicators
    Bibliography
    Annex ZA (informative) - Relationship between this
             European Standard and the essential
             requirements of Directive 93/42/EEC [OJ L 169]
             aimed to be covered

    Abstract - (Show below) - (Hide below)

    Describes the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which may be necessary in order to achieve the required performance.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current

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

    EN 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 11737-2:2009)
    IEC 61010-2-040:2015 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
    EN 13624:2013 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1)
    ISO 15883-1:2006 Washer-disinfectors Part 1: General requirements, terms and definitions and tests
    EN ISO 15883-3:2009 Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)
    EN 61010-2-040:2015 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
    ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
    ISO 15883-6:2011 Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
    ISO 15883-3:2006 Washer-disinfectors Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
    CEN ISO/TS 15883-5:2005 Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy (ISO/TS 15883-5:2005)
    EN 14348:2005 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1)
    EN 10088-2:2014 STAINLESS STEELS - PART 2: TECHNICAL DELIVERY CONDITIONS FOR SHEET/PLATE AND STRIP OF CORROSION RESISTING STEELS FOR GENERAL PURPOSES
    EN ISO 15883-4:2009 Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)
    EN 13727:2012+A2:2015 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1)
    EN ISO 15883-6:2015 Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)
    ISO/TS 15883-5:2005 Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
    ISO 15883-4:2008 Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
    EN ISO 15883-1:2009/A1:2014 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006/AMD 1:2014)
    EN 14476:2013+A1:2015 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1)
    EN 1040:2005 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1)
    ISO 15883-2:2006 Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
    EN ISO 15883-2:2009 Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006)
    EN 10088-1:2014 Stainless steels - Part 1: List of stainless steels
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