• CAN/CSA-ISO 15883-7:17

    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 (Adopted ISO 15883-7:2016, first edition, 2016-02-01)

    Available format(s):  Hardcopy, PDF

    Language(s):  English, French

    Published date:  01-01-2017

    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 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

    Abstract - (Show below) - (Hide below)

    Defines the particular requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items.

    Scope - (Show below) - (Hide below)

    This is the first edition of CAN/CSA-ISO 15883-7, Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 15883-7 (first edition, 2016-02-01). Scope This part of ISO 15883 specifies the particular requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items such as the following: a) bedframes; b) bedside tables; c) transport carts; d) containers; e) surgical tables; f) sterilization containers; g) surgical clogs; h) wheelchairs, aids for the disabled. This part of ISO 15883 also specifies 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. Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO I5883-4, and ISO 15883-6 do not fall within the scope of this part of ISO 15883. In addition, the methods are specified, as well as instrumentation and instructions required for type testing, works testing, validation (installation, operation, and performance qualification on first installation), routine control, and monitoring, as well as requalifications required to be carried out periodically and after essential repairs. NOTE WDs corresponding to this part of ISO 15883 can also be used for cleaning and chemical disinfection of other thermolabile and reusable devices as recommended by the device manufacturer. The performance requirements specified in this part of ISO 15883 may not ensure the inactivation or removal of the causative agent(s) (prion proteins) of Transmissible Spongiform Encephalopathies.

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

    Document Type Standard
    Publisher Canadian Standards Association
    Status Current

    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
    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
    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 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
    ISO 15883-4:2008 Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
    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 10088-1:2014 Stainless steels - Part 1: List of stainless steels
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