• EN 16442:2015

    Current The latest, up-to-date edition.

    Controlled environment storage cabinet for processed thermolabile endoscopes

    Available format(s): 

    Language(s): 

    Published date:  18-03-2015

    Publisher:  Comite Europeen de Normalisation

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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)

    This European Standard specifies the performance requirements applying to cabinets designed to store, or store and dry, thermolabile endoscopes following automated or manual processing.The storage cabinets are designed to provide a controlled environment for storage of endoscope(s), with or without channels, and when necessary drying of the endoscope(s), including the endoscope(s) channels.The controlled environment provided by the storage cabinet ensures that during storage there is no deterioration of the microbiological quality of the endoscope. The drying function is intended to supplement, if necessary, any drying provided as part of the automated or manual processing cycle.This European Standard specifies storage cabinets which flush the channels and the external surfaces of endoscopes with air.NOTE 1The storage cabinet is one of the means that can allow the safe use of the endoscope for an extended period from the time of processing and improve availability for emergency use.NOTE 2Thorough drying of an endoscope in a washer-disinfector can require a prolonged cycle time; the use of a storage cabinet including a drying function can enhance throughput of the endoscopes.The cabinet is not intended to provide any cleaning or disinfection function.This European Standard does not include the use of other chemicals for drying and maintaining the quality of endoscopes during storage

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

    Committee CEN/TC 102
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current

    Standards Referenced By This Book - (Show below) - (Hide below)

    BS EN ISO 17664:2017 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices
    ANSI/AAMI/ISO 17664:2017 PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES
    I.S. EN ISO 17664:2017 PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017)
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
    16/30280931 DC : DRAFT APR 2016 BS EN ISO 17664 - PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES
    EN ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017)

    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)
    AS 5330:2019 Drying cabinets for reusable medical devices
    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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