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    I.S. EN ISO 15883-2:2009

    Current The latest, up-to-date edition.

    WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.

    Available format(s):  Hardcopy, PDF

    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
      4.1 General
      4.2 Cleaning
      4.3 Disinfecting
      4.4 Temperature of internal surfaces of processed devices
    5 Mechanical and control requirements
      5.1 Load connectors
      5.2 Control systems
      5.3 Process verification
    6 Testing for conformity
      6.1 General
      6.2 Tests for soil removal from chamber walls, load carrier
          and load
      6.3 Thermometric tests
    7 Information to be supplied by the manufacturer
    8 Information to be requested from the purchaser by the supplier
      of the WD
    Annex A (informative) - Summary of test programmes
    Annex ZA (informative) - Relationship between this European
                             Standard and the Essential Requirements
                             of EU Directive 93/42/EEC
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines particular requirements for washer-disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of re-usable medical devices such as surgical instruments, anaesthetic equipment, bowls, dishes and receivers, utensils and glassware.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    BS 2745-3:1993 Washer-disinfectors for medical purposes Specification for washer-disinfectors except those used for processing human-waste containers and laundry
    ISO 15883-1:2006 Washer-disinfectors Part 1: General requirements, terms and definitions and tests
    ISO 4017:2014 Fasteners Hexagon head screws Product grades A and B
    EN 10088-2:2014 STAINLESS STEELS - PART 2: TECHNICAL DELIVERY CONDITIONS FOR SHEET/PLATE AND STRIP OF CORROSION RESISTING STEELS FOR GENERAL PURPOSES
    ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
    ISO 5367:2014 Anaesthetic and respiratory equipment — Breathing sets and connectors
    ISO 5362:2006 Anaesthetic reservoir bags
    ISO/TS 15883-5:2005 Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
    IEC 61010-2-045:2000 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-045: Particular requirements for washer disinfectors used in medical, pharmaceutical, veterinary and laboratory fields
    ISO 5361:2016 Anaesthetic and respiratory equipment — Tracheal tubes and connectors
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
    View more information

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