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    I.S. EN 80369-5:2016

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS

    Available format(s):  Hardcopy, PDF

    Superseded date:  24-07-2021

    Language(s):  English

    Published date:  01-01-2017

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    National Foreword
    FOREWORD
    INTRODUCTION
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Dimensional requirements for
      sphygmomanometer and cuff SMALL-BORE CONNECTORS
    6 Performance requirements
    Annex A (informative) - Rationale and guidance
    Annex B (normative) - SMALL-BORE CONNECTORS for
            the limb cuff inflation APPLICATION
    Annex C (normative) - Reference CONNECTORS
    Annex D (informative) - Assessment of MEDICAL
            DEVICES and their attributes with CONNECTIONS
            within this APPLICATION
    Annex E (informative) - Summary of the usability
            requirements for SMALL-BORE CONNECTORS for
            limb cuff inflation APPLICATIONS
    Annex F (informative) - Summary of SMALL-BORE
            CONNECTOR design requirements for limb cuff
            inflation APPLICATIONS
    Annex G (informative) - Summary of assessment
            of the design of the CONNECTORS for limb cuff
            inflation APPLICATION
    Annex H (informative) - Obsolete limb cuff inflation
            CONNECTOR
    Annex I (informative) - Air leakage by pressure decay
            TEST METHOD
    Annex J (informative) - Resistance to separation from
            axial load TEST METHOD
    Annex K (informative) - Reference to the essential principles
    Index of defined terms
    Bibliography
    Annex ZA (normative) - Normative references to
             international publications with their
             corresponding European publications
    Annex ZZ (informative) - Relationship between this
             European standard and the essential
             requirements of Directive 93/42/EEC
             [OJ L 169] aimed to be covered

    Abstract - (Show below) - (Hide below)

    Defines dimensions and requirements for the design and functional performance of SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in limb cuff inflation APPLICATIONS of MEDICAL DEVICES and ACCESSORIES.

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

    Development Note 2016 Edition issued incorporating corrigendum 2017. (05/2017)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By

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

    ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications Part 20: Common test methods
    EN ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)
    ISO 81060-1:2007 Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type
    EN ISO 80369-1:2010 Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    ANSI B11 : 2008 GENERAL SAFETY REQUIREMENTS COMMON TO ANSI B11 MACHINES
    ISO 3040:2016 Geometrical product specifications (GPS) Dimensioning and tolerancing Cones
    ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
    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
    ISO 80369-6:2016 Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neuraxial applications
    ASTM D 790 : 2017 : REDLINE Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
    IEC 80601-2-30:2009+AMD1:2013 CSV Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
    EN ISO 5356-2:2012 Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2012)
    ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    EN ISO 8185:2009 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)
    ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
    ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
    ASTM D 638 : 2014 : REDLINE Standard Test Method for Tensile Properties of Plastics
    ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications
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