• BS EN ISO 15883-4:2009

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    Washer-disinfectors Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes

    Available format(s):  Hardcopy, PDF

    Superseded date:  08-01-2019

    Language(s):  English

    Published date:  30-09-2009

    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 Performance requirements
       4.1 General
       4.2 Systems for leak testing
       4.3 Cleaning
       4.4 Disinfecting
       4.5 Final (post-disinfection) rinsing
       4.6 Purging to remove rinse water
       4.7 Drying
       4.8 Self-disinfection
       4.9 Water treatment equipment
    5 Mechanical and process requirements
       5.1 Materials - Design, manufacture and construction
       5.2 Device channel irrigation system
       5.3 Venting and drainage systems
       5.4 Temperature control
       5.5 Process chemicals
       5.6 Process verification
       5.7 Dosing systems
    6 Testing for conformity
       6.1 General
       6.2 Test equipment
       6.3 Water used for final (post-disinfection) rinsing
       6.4 Hardness of water used during type testing
       6.5 Leak test
       6.6 Channels non-obstruction test
       6.7 Channels non-connection test
       6.8 Load dryness
       6.9 Thermometric tests
       6.10 Chemical dosing tests
       6.11 Tests of cleaning efficacy
       6.12 Test of disinfection efficacy
    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
    Annex ZA (informative) - Relationship between this European Standard
                             and the Essential Requirements of EU
                             Directive 93/42/EEC

    Abstract - (Show below) - (Hide below)

    Defines 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)

    Committee CH/198
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

    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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