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  • UNI 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.

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    Published date:  02-09-2009

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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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)

    Describes 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)

    Committee CT 44
    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    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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