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  • CSA Z15883-4 : 2009

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008, IDT)

    Available format(s):  Hardcopy, PDF

    Superseded date:  11-11-2020

    Language(s):  English, French

    Published date:  01-01-2014

    Publisher:  Canadian Standards Association

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Performance requirements
    5 Mechanical and process requirements
    6 Testing for conformity
    7 Documentation and inspection
    8 Information to be supplied by the manufacturer
    9 Marking, labelling and packaging
    10 Information to be requested from the purchaser by
       the manufacturer
    Annex A (informative) - Summary of activities covered
            by this Part of ISO 15883
    Annex B (normative) - Microbiological testing of the
            efficacy of chemical disinfection of the load
    Annex C (informative) - Summary of test programmes
    Annex D (normative) - Methods for microbiological evaluation
            of disinfection of liquid transport system
    Annex E (normative) - Tests for microbial contamination of
            post-disinfection rinse water
    Annex F (informative) - Typical specifications of trumpet
            valves and connection ports
    Annex G (informative) - Additional notes on microbiological
            testing of chemical disinfection processes
    Bibliography

    Abstract - (Show below) - (Hide below)

    This part of ISO 15883 specifies the particular requirements, including performance, for washer-disinfectors (WDs) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes.

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

    Document Type Standard Guideline
    Product Note Reconfirmed EN
    Publisher Canadian Standards Association
    Status Superseded
    Superseded By

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

    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 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)
    ISO 11731-2:2004 Water quality Detection and enumeration of Legionella Part 2: Direct membrane filtration method for waters with low bacterial counts
    EN 1717:2000 Protection against pollution of potable water in water installations and general requirements of devices to prevent pollution by backflow
    ISO 384:2015 Laboratory glass and plastics ware Principles of design and construction of volumetric instruments
    EN 12353:2013 Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
    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)
    ISO/TS 15883-5:2005 Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
    EN 14562 : 2006 CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE CARRIER TEST FOR THE EVALUATION OF FUNGICIDAL OR YEASTICIDAL ACTIVITY FOR INSTRUMENTS USED IN THE MEDICAL AREA - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 2)
    ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
    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 14561 : 2006 CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE CARRIER TEST FOR THE EVALUATION OF BACTERICIDAL ACTIVITY FOR INSTRUMENTS USED IN THE MEDICAL AREA - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 2)
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