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  • EN ISO 15883-1:2009/A1:2014

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    WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006/AMD 1:2014)

    Available format(s): 

    Language(s): 

    Published date:  16-07-2014

    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 process requirements
    6 Testing for conformity
    7 Documentation
    8 Information to be supplied by the manufacturer
    9 Marking, labelling and packaging
    10 Information to be requested from the purchaser by the
       supplier of the WD
    Annex A (informative) - Test programme
    Annex B (informative) - A[O] concept - Comparative lethality
                            of moist heat processes
    Annex C (normative) - Test methods for the detection and
                          assessment of residual proteinaceous
                          contamination
    Annex D (normative) - Microbiological recovery medium for
                          estimation of bacterial contamination
                          of water
    Bibliography
    Annex ZA (informative) - Relationship between this European
                             Standard and the Essential Requirements
                             of EU Directive 93/42/EEC on medical
                             devices

    Abstract - (Show below) - (Hide below)

    Describes general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice.

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

    Committee CEN/TC 102
    Development Note Supersedes PREN ISO 15883-1. (06/2006)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current
    Supersedes

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

    12/30248648 DC : DRAFT AUG 2012 BS EN 16442 - CONTROLLED ENVIRONMENT STORAGE CABINET FOR DISINFECTED THERMOLABILE ENDOSCOPES
    BS EN 16442 : 2015 CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES
    I.S. EN 285:2015 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    DIN EN ISO 15883-7 E : 2016 WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016)
    DIN EN ISO 15883-7:2016-10 WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016)
    08/30184602 DC : DRAFT SEP 2008 BS EN 1639 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
    VDI 2083 Blatt 18:2012-01 Cleanroom technology - Biocontamination control
    VDI 5700-1 : 2015 REPROCESSING HAZARDS - RISK MANAGEMENT IN REPROCESSING OF MEDICAL DEVICES - MEASURES FOR RISK CONTROL
    DIN EN 16442 E : 2015 CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES
    13/30278676 DC : 0 BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    PREN 285 : DRAFT 2013 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    UNE-EN ISO 15883-7:2016 Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016)
    DIN EN 16442:2015-05 CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES
    UNE-EN 16442:2015 Controlled environment storage cabinet for processed thermolabile endoscopes
    EN 13060 : 2014 SMALL STEAM STERILIZERS
    I.S. EN ISO 15883-7:2016 WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016)
    UNE-EN 13060:2015 Small steam sterilizers
    I.S. EN 16442:2015 CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES
    BS EN ISO 15883-7:2016 Washer-disinfectors Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
    ISO 15883-7:2016 Washer-disinfectors Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
    EN 285 : 2015 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    DIN EN 13060:2015-03 SMALL STEAM STERILIZERS
    DIN EN 1639:2010-02 Dentistry - Medical devices for dentistry - Instruments
    DIN EN 285:2016-05 Sterilization - Steam sterilizers - Large sterilizers
    UNE-EN 285:2016 Sterilization - Steam sterilizers - Large sterilizers
    BS EN 1639 : 2009 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
    BS EN 13060 : 2014 SMALL STEAM STERILIZERS
    BS EN 285 : 2015 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    I.S. EN 1639:2009 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
    EN ISO 15883-7 : 2016 WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016)
    EN 1639 : 2009 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
    EN 16442 : 2015 CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES

    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 285 : 2015 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    IEC 60073:2002 Basic and safety principles for man-machine interface, marking and identification - Coding principles for indicators and actuators
    ISO 11737-2:2009 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
    ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
    ISO 15883-3:2006 Washer-disinfectors Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    EN 1717 : 2000 PROTECTION AGAINST POLLUTION OF POTABLE WATER IN WATER INSTALLATIONS AND GENERAL REQUIREMENTS OF DEVICES TO PREVENT POLLUTION BY BACKFLOW
    ISO 12100:2010 Safety of machinery General principles for design Risk assessment and risk reduction
    ISO/TS 15883-5:2005 Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
    ISO 14698-1:2003 Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods
    ISO 14644-3:2005 Cleanrooms and associated controlled environments Part 3: Test methods
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    ISO 15883-4:2008 Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
    ISO 13849-2:2012 Safety of machinery Safety-related parts of control systems Part 2: Validation
    DIN 58955-3:1998-09 DECONTAMINATION-APPARATUS IN THE MEDICAL FIELD - EFFICIENCY TESTING
    IEC 80416-1:2008 BASIC PRINCIPLES FOR GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - PART 1: CREATION OF GRAPHICAL SYMBOLS FOR REGISTRATION
    ISO 10012:2003 Measurement management systems Requirements for measurement processes and measuring equipment
    IEC 60751:2008 Industrial platinum resistance thermometers and platinum temperature sensors
    ISO 9001:2015 Quality management systems Requirements
    ISO 9000:2015 Quality management systems Fundamentals and vocabulary
    ISO 11138-1:2017 Sterilization of health care products Biological indicators Part 1: General requirements
    EN 1822-1 : 2009 HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 1: CLASSIFICATION, PERFORMANCE TESTING, MARKING
    IEC 61508-1:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements (see Functional Safety and IEC 61508)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    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.
    DIN 10510:2013-10 FOOD HYGIENE - COMMERCIAL DISHWASHING WITH MULTITANK-TRANSPORTDISHWASHERS - HYGIENE REQUIREMENTS, PROCEDURE TESTING
    IEC 60584-1:2013 Thermocouples - Part 1: EMF specifications and tolerances
    ISO 228-1:2000 Pipe threads where pressure-tight joints are not made on the threads Part 1: Dimensions, tolerances and designation
    ISO 17665-1:2006 Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
    1997/23/EC : 1997 DIRECTIVE 97/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 29 MAY 1997 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES CONCERNING PRESSURE EQUIPMENT
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