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  • DIN EN ISO 80369-1:2015-09 (Draft)

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS

    Available format(s):  Hardcopy, PDF

    Superseded date:  07-03-2021

    Language(s):  German

    Published date:  01-01-2015

    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 für Verbindungsstücke
      mit kleinem Durchmesser
    5 Anforderungen an Verbindungsstücke mit
      kleinem Durchmesser für spezifische
      Anwendungen
      5.1 Inkompatibilität von Verbindungsstücken
          mit kleinem Durchmesser
      5.2 Intravasculäre oder subkutane Anwendungen
      5.3 Anwendungen in Atemsystemen und Antriebsgasen
      5.4 Enterale Anwendungen
      5.5 Urethrale und urologische Anwendungen
      5.6 Anwendungen in Systemen mit aufblasbarer
          Manschette für Gliedmassen
      5.7 Neuroaxiale Anwendungen
      5.8 Alternative Verbindungsstücke mit kleinem
          Durchmesser
    6 Verfahren zur Beurteilung einer vorgeschlagenen neuen
          Ausführung eines Verbindungsstücks mit kleinem
          Durchmesser zur Aufnahme in diese Normenreihe
      6.1 Allgemeines
      6.2 Einleitung eines Vorschlags
      6.3 Verfahren zur Bewertung der Annehmbarkeit und der
          Merkmale der nicht miteinander Verbindbarkeit
          6.3.1 Ausführung
          6.3.2 Ausführungsrealisierung
          6.3.3 Verifizierung der Ausführung
          6.3.4 Bestätigung der Ausführung
      6.4 Überprüfung der Ausführung
      6.5 Nachfolgende Teile dieser Normenreihe
    Anhang A (informativ) Begründung
    Anhang B (normativ) Mechanische Prüfungen zur
              Bestätigung der Merkmale der nicht
              miteinander Verbindbarkeit
    Anhang C (informativ) Anwendungen von Verbindungsstücken
              mit kleinem Durchmesser
    Anhang D (informativ) Verweis auf grundlegende Prinzipien
    Anhang ZA (informativ) Zusammenhang zwischen diesem
              Dokument und den grundlegenden Anforderungen
              der EG-Richtlinie 93/42/EWG
    Literaturhinweise
    Stichwortverzeichnis

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

    Comment Closes On
    Development Note Supersedes DIN EN 15546-1. (04/2011) DRAFT 2015 issued in September 2015. (09/2015)
    Document Type Draft
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Supersedes

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

    DIN 13273-8:2012-09 CATHETER FOR MEDICAL USE - PART 8: EPIDURAL CATHETERS
    DIN EN ISO 80601-2-72:2016-04 Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015)
    DIN EN ISO 10079-3:2014-09 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014)
    DIN EN ISO 10079-2:2014-09 Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014); German version EN ISO 10079-2:2014
    DIN EN ISO 80369-20:2015-09 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2015); German version EN ISO 80369-20:2015
    DIN ISO 11040-4:2007-10 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
    DIN EN ISO 80601-2-69:2014-12 Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)

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

    DIN EN ISO 5359:2015-02 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014)
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
    ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    CR 13825:2000 Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings"
    ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
    ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
    DIN EN ISO 5356-1:2015-06 ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 1: CONES AND SOCKETS (ISO 5356-1:2015)
    ASTM D 790 : 2017 : REDLINE Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
    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 14971:2007 Medical devices Application of risk management to medical devices
    EN 13544-2:2002+A1:2009 Respiratory therapy equipment - Part 2: Tubing and connectors
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