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    I.S. EN ISO 15883-1:2009

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006)

    Available format(s):  Hardcopy, PDF

    Superseded date:  16-07-2020

    Language(s):  English

    Published date:  01-01-2009

    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 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)

    Document Type Standard
    Publisher National Standards Authority of Ireland
    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 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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