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  • DIN EN 12342:2010-01

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-02-2015

    Language(s):  English

    Published date:  01-01-2010

    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 Werkstoffe
    5 Ausführung
    6 Länge
    7 Durchflusswiderstand
    8 Verbindungsstücke
    9 Lecksicherheit
    10 Zunahme des Durchflusswiderstandes bei Biegung
    11 Compliance von Atemschläuchen
    12 Vom Hersteller bereitzustellende Informationen
    13 Elektrischer Widerstand
    14 Anforderungen an steril gelieferte Atemschläuche
    15 Kennzeichnung
    16 Gebrauchstauglichkeit
    17 Klinische Bewertung
    18 Biophysikalische oder an Modellen durchgeführte
       Untersuchungen
    Anhang A (normativ) Prüfung des Durchflusswiderstandes
    Anhang B (normativ) Prüfung der Sicherheit der Verbindung
              des glatten Endes mit einem Verbindungsstück
              geeigneter Grösse mit Aussenkegel
    Anhang C (normativ) Prüfung der Sicherheit der Verbindung
              eines Adapters mit dem Atemschlauch
    Anhang D (normativ) Prüfung der Lecksicherheit
    Anhang E (normativ) Prüfung der Zunahme des
              Durchflusswiderstandes bei Biegung
    Anhang F (normativ) Prüfung der Compliance
    Anhang G (informativ) Empfehlungen für Werkstoffe und
              Ausführung
    Anhang H (informativ) Literaturhinweise
    Anhang ZA (informativ) Zusammenhang zwischen dieser
              Europäischen Norm und den grundlegenden
              Anforderungen der EG-Richtlinie 93/42/EWG

    Abstract - (Show below) - (Hide below)

    Describes the basic requirements for breathing tubes and breathing tubing supplied to be cut to length, intended for use with anaesthetic apparatus and ventilators, humidifiers and nebulizers.

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

    Development Note A transition period, as set out in DIN EN ISO 5367 issue 02-2015 exists until 31-10-2017. (02/2015)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By

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

    EN 556:1994 + A1:1998 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
    EN 740:1998/A1:2004 ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    EN 868-1 : 1997 PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS
    EN 60601-1-6:2010/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013)
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 468:1982 Surface roughness — Parameters, their values and general rules for specifying requirements
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    EN 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
    EN 1281-1:1997/A1:1998 ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - CONES AND SOCKETS
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    EN ISO 4135:2001 ANAESTHETIC AND RESPIRATORY EQUIPMENT - VOCABULARY
    EN 980:2008 Symbols for use in the labelling of medical devices
    EN 30993-1 : 1994 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON SELECTION OF TESTS
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