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  • DIN EN ISO 15883-4:2016-07 (Draft)

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES

    Available format(s):  Hardcopy, PDF

    Superseded date:  07-03-2021

    Language(s):  German

    Published date:  01-01-2016

    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 Systeme für die Dichtheitsprüfung
       4.3 Reinigung
       4.4 Desinfektion
       4.5 Nachspülen (nach der Desinfektion)
       4.6 Beseitigung von Spülwasser
       4.7 Trocknen
       4.8 Selbstdesinfektion
       4.9 Wasseraufbereitungsanlage
    5 Anforderungen an die Mechanik und den Prozess
       5.1 Werkstoffe - Gestaltung, Herstellung und Konstruktion
       5.2 Kanaldurchspülungssystem des Geräts
       5.3 Belüftungs- und Abflusssysteme
       5.4 Temperaturregelung
       5.5 Prozesschemikalien
       5.6 Prozessüberprüfung
       5.7 Dosiersysteme
    6 Prüfung auf Konfomität
       6.1 Allgemeines
       6.2 Prüfgeräte
       6.3 Für das abschliessende Spülen (nach der Desinfektion)
            verwendetes Wasser
       6.4 Härte des bei der Typprüfung verwendeten Wassers
       6.5 Dichtheitsprüfung
       6.6 Prüfung auf Durchgängigkeit der Kanäle
       6.7 Prüfung auf nicht angeschlossene Kanäle
       6.8 Trockenheit der Beladung
       6.9 Thermometrische Prüfungen
       6.10 Prüfungen auf Chemikaliendosierung
       6.11 Prüfungen für die Wirksamkeit der Reinigung
       6.12 Prüfungen der Wirksamkeit der Desinfektion
    7 Dokumentation und Inspektion
    8 Vom Hersteller zu erbringende Angaben
    9 Kennzeichnung, Beschilderung und Verpackung
    10 Angaben, die der Hersteller vom Käufer fordern muss
    Anhang A (informativ) Zusammenfassung der in diesem
              Teil der ISO 15883 behandelten Tätigkeiten
    Anhang B (normativ) Mikrobiologische Prüfung der
              Wirksamkeit der chemischen Desinfektion
              der Beladung
    Anhang C (informativ) Zusammenfassung der Prüfprogramme
    Anhang D (normativ) Verfahren zur mikrobiologischen
              Bewertung der Desinfektion von
              Flüssigkeitstransportsystemen
    Anhang E (normativ) Prüfungen auf mikrobielle
              Kontamination des Spülwassers nach der
              Desinfektion
    Anhang F (informativ) Typische Spezifikationen von
              Trompetenventilen und Anschlüssen
    Anhang G (informativ) Zusätzliche Anmerkungen zur
              mikrobiologischen Prüfung chemischer
              Desinfektionsprozesse
    Literaturhinweise
    Anhang ZA (informativ) Zusammenhang zwischen dieser
              Internationalen Norm und den grundlegenden
              Anforderungen der EG-Richtlinie 93/42/EWG
              über Medizinprodukte

    Abstract - (Show below) - (Hide below)

    Diese Europäische Norm legt Leistungsanforderungen und Prüfverfahren für Reinigungs-Desinfektionsgeräte fest, die für die Reinigung und Desinfektion von thermolabilen wiederverwendbaren Instrumenten einschliesslich Endoskopen verwendet werden.

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

    Comment Closes On
    Development Note DRAFT 2016 issued in July 2016. (07/2016)
    Document Type Draft
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded

    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)

    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 13624:2013 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1)
    ISO 15883-1:2006 Washer-disinfectors Part 1: General requirements, terms and definitions and tests
    VDE 0411-2-040 : 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)
    EN 14348:2005 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1)
    ISO 11731-2:2004 Water quality Detection and enumeration of Legionella Part 2: Direct membrane filtration method for waters with low bacterial counts
    EN 1717:2000 Protection against pollution of potable water in water installations and general requirements of devices to prevent pollution by backflow
    ISO 384:2015 Laboratory glass and plastics ware Principles of design and construction of volumetric instruments
    EN 12353:2013 Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
    EN 13727:2012+A2:2015 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1)
    ISO/TS 15883-5:2005 Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
    EN 14562 : 2006 CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE CARRIER TEST FOR THE EVALUATION OF FUNGICIDAL OR YEASTICIDAL ACTIVITY FOR INSTRUMENTS USED IN THE MEDICAL AREA - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 2)
    DIN EN ISO 11138-1:2015-10 (Draft) STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017)
    ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
    EN 14476:2013+A1:2015 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1)
    EN 14561 : 2006 CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE CARRIER TEST FOR THE EVALUATION OF BACTERICIDAL ACTIVITY FOR INSTRUMENTS USED IN THE MEDICAL AREA - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 2)
    DIN ISO 384:1978-12 LABORATORY GLASSWARE; PRINCIPLES OF DESIGN AND CONSTRUCTION OF VOLUMETRIC GLASSWARE
    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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