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  • DIN EN ISO 15883-2:2009-09

    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:  German Institute for Standardisation (Deutsches Institut für Normung)

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    Table of Contents - (Show below) - (Hide below)

    Vorwort
    Einleitung
    1 Anwendungsbereich
    2 Normative Verweisungen
    3 Begriffe
    4 Leistungsanforderungen
      4.1 Allgemeines
      4.2 Reinigung
      4.3 Desinfektion
      4.4 Temperatur innerer Oberflächen behandelter Produkte
    5 Mechanische und steuerungstechnische Anforderungen
      5.1 Konnektoren für die Beladung
      5.2 Regel- und Steuersysteme
      5.3 Prozessverifizierung
    6 Prüfung auf Konformität mit der Norm
      6.1 Allgemeines
      6.2 Prüfungen der Schmutzentfernung von den
          Kammerwänden, vom Beladungsträger und
          der Beladung
      6.3 Thermometrische Prüfungen
    7 Vom Hersteller anzugebende Informationen
    8 Durch den Lieferanten des RDG vom Käufer zu
      fordernde Informationen
    Anhang A (informativ) Übersicht über die Prüfprogrammee

    Literaturhinweise
    Anhang ZA (informativ) Zusammenhang zwischen dieser
              Europäischen Norm und den grundlegenden
              Anforderungen der EG-Richtlinie 93/42/EWG über
              Medizinprodukt

    Abstract - (Show below) - (Hide below)

    Diese Europäische Norm legt Anforderungen und Prüfverfahren für Reinigungs-Desinfektionsgeräte fest, die für die Reinigung und thermische Desinfektion wieder verwendbarer medizinischer Produkte wie chirurgische Instrumente, Anästhesiegeräte, Schüsseln, Schalen, Auffanggeräte, Utensilien und Glaswaren in einem einzigen Prozessablauf bestimmt sind.

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

    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Current

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

    DIN EN ISO 11135:2014-10 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014)
    DIN EN ISO 15883-6:2016-04 Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)
    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)

    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
    DIN EN ISO 17664:2016-06 (Draft) PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017)
    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
    DIN EN ISO 5356-2:2013-03 ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 2: SCREW-THREADED WEIGHT-BEARING CONNECTORS (ISO 5356-2:2012)
    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
    DIN EN 61010-2-040 : 2016 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 (IEC 61010-2-040:2015)
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