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  • DIN EN 1282-2:2009-12

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-04-2017

    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 Grössen und Masse
    5 Werkstoffe
    6 Ausführung
    7 Anforderungen an steril gelieferte Tracheotomietuben
    8 Kennzeichnung
    9 Adapter
    Anhang A (normativ) Prüfung der sicheren Befestigung
              eines dauerhaft angebrachten Verbindungsstücks,
              soweit vorhanden, und der Halsplatte am
              Tracheotomietubus
    Anhang B (normativ) Bestimmung des Durchmessers des
              gefüllten, jedoch nicht gedehnten Cuffs
    Anhang C (informativ) Leitfaden für Werkstoffe und
              Ausführung
    Anhang ZA (informativ) Zusammenhang zwischen dieser
              Europäischen Norm und den grundlegenden
              Anforderungen der EG-Richtlinie 93/42/EWG
    Literaturhinweise

    Abstract - (Show below) - (Hide below)

    Dieses Dokument legt Anforderungen an pädiatrische Trachetomietuben aus Kunststoffen und/oder Gummi mit einem Innendurchmesser von 2,0 mm bis 6,0 mm fest.

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

    Development Note Supersedes DIN EN ISO 5366-3 issue 12-2003. (09/2005)
    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    Status Superseded
    Superseded By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 ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 5366-1:2000 Anaesthetic and respiratory equipment Tracheostomy tubes Part 1: Tubes and connectors for use in adults
    EN ISO 5366-1:2009 Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 11607:2003 Packaging for terminally sterilized medical devices
    ISO 5361:2016 Anaesthetic and respiratory equipment — Tracheal tubes and connectors
    ISO/TR 11991:1995 Guidance on airway management during laser surgery of upper airway
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    EN 20594-1:1993/A1:1997 CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - GENERAL REQUIREMENTS
    EN 980:2008 Symbols for use in the labelling of medical devices
    EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
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