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  • DIN EN ISO 5366-1:2009-07

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS

    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    Superseded date:  01-04-2017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
      4.1 Innendurchmesser
      4.2 Aussendurchmesser
      4.3 Länge
      4.4 Winkel [theta]
    5 Werkstoffe
    6 Ausführung
      6.1 Maschinenende
      6.2 Halsplatte
      6.3 Innentubus
      6.4 Cuff
      6.5 Füllschläuche für Cuffs
      6.6 Patientenende
      6.7 Einführhilfe
    7 Anforderungen an steril gelieferte Tracheotomietuben
      7.1 Zusicherung von Sterilität
      7.2 Verpackung steril gelieferter Tracheotomietuben
    8 Kennzeichnung
      8.1 Allgemeines
      8.2 Kennzeichnung der Halsplatte
      8.3 Kennzeichnung der Einzelpackungen
    Anhang A (normativ) Prüfung der sicheren Befestigung
              eines Verbindungsstücks und einer
              Halsplatte am Tracheotomietubus
    Anhang B (normativ) Bestimmung des Durchmessers
              des gefüllten, jedoch nicht gedehnten Cuffs
    Anhang C (informativ) Leitfaden für Werkstoffe
              und Ausführung
    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 requirements for tracheostomy tubes made of plastics materials and/or rubber having inside diameters of 6.5 mm or greater.

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

    Development Note Supersedes DIN EN 1282-1. (10/2004)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By
    Supersedes

    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"
    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
    DIN EN 20594-1:1995-01 CONICAL FITTINGS WITH A 6 % (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 5366-3:2001 Anaesthetic and respiratory equipment Tracheostomy tubes Part 3: Paediatric tracheostomy tubes
    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 980:2008 Symbols for use in the labelling of medical devices
    ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
    DIN EN ISO 4135:2002-03 Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001); Trilingual version EN ISO 4135:2001
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