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    I.S. EN 16442:2015

    Current The latest, up-to-date edition.

    CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2015

    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)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Performance requirements
    5 Mechanical and procedure requirements
    6 Testing for conformity
    7 Documentation
    8 Information to be supplied with the storage cabinet
    9 Information to be requested from the purchaser by the
      manufacturer
    Annex A (informative) - Summary of test programmes
    Annex B (informative) - Cross-contamination between endoscopes
    Annex C (normative) - Methods for evaluation of airborne microbial
            contamination in the storage cabinet
    Annex D (informative) - Procedure for parametric performance
            qualification
    Annex E (normative) - Internal residual contamination of endoscopes
            after storage
    Annex F (normative) - Establishing endoscope type test groups
    Annex G (normative) - Establishing endoscope product families
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines the performance requirements applying to cabinets designed to store, or store and dry, thermolabile endoscopes following automated or manual processing.

    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)

    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
    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)
    ISO 8573-1:2010 Compressed air Part 1: Contaminants and purity classes
    ISO 14644-3:2005 Cleanrooms and associated controlled environments Part 3: Test methods
    EN 60751:2008 INDUSTRIAL PLATINUM RESISTANCE THERMOMETERS AND PLATINUM TEMPERATURE SENSORS
    ISO 15883-4:2008 Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
    EN 60584-1:2013 Thermocouples - Part 1: EMF specifications and tolerances
    ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
    IEC 60751:2008 Industrial platinum resistance thermometers and platinum temperature sensors
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    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 1822-1:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking
    IEC 60584-1:2013 Thermocouples - Part 1: EMF specifications and tolerances
    EN ISO 14644-1:2015 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015)
    EN ISO 14644-3:2005 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS
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