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  • CEI UNI EN ISO 80369-1 : 2011

    Current The latest, up-to-date edition.

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

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2011

    Publisher:  Comitato Elettrotecnico Italiano

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Materials used for SMALL-BORE CONNECTORS
    5 Requirements for SMALL-BORE CONNECTORS for
      specific APPLICATIONS
    6 Additional SMALL-BORE CONNECTOR APPLICATIONS
    7 PROCEDURE to assess a proposed new design of SMALL-BORE
      CONNECTOR for inclusion in this series of standards
    Annex A (informative) - Rationale
    Annex B (normative) - Mechanical tests for verifying
            NON-INTERCONNECTABLE characteristics
    Annex C (informative) - APPLICATIONS of SMALL-BORE CONNECTORS
    Annex D (informative) - Reference to the Essential Principles
    Bibliography
    Terminology - Alphabetized index of defined terms
    Annex ZA (informative) - Relationship between this European
             Standard and the Essential Requirements of EU
             Directive 93/42/EEC

    Abstract - (Show below) - (Hide below)

    Defines general requirements for SMALL-BORE CONNECTORS, which convey liquids or gases in healthcare APPLICATIONS.

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

    Committee CT 62
    Development Note Supersedes CEI UNI EN 15546-1. (04/2011)
    Document Type Standard
    Publisher Comitato Elettrotecnico Italiano
    Status Current
    Supersedes

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

    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
    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
    ASTM D 790 : 2017 : REDLINE Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
    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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