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    I.S. EN ISO 80369-7:2017 COR 2017

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS (ISO 80369-7:2016, CORRECTED VERSION 2016-12-01)

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-02-2019

    Language(s):  English

    Published date:  04-07-2017

    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
    European foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Dimensional requirements for luer
      connectors
    6 Performance requirements
    Annex A (informative) - Rationale and guidance
    Annex B (normative) - luer connectors
    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 luer connectors for
            intravascular or hypodermic applications
    Annex F (informative) - Summary of luer connector
            design requirements for intravascular or
            hypodermic applications
    Annex G (informative) - Summary of assessment of the
            design of the luer connector for intravascular or
            hypodermic applications
    Annex H (informative) - Reference to the essential
            principles
    Annex I (informative) - Terminology - Alphabetized index
            of defined terms
    Bibliography
    Annex ZA (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 intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories.

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

    Development Note Supersedes I.S. EN 1707 & I.S. EN 20594-1. (06/2017)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By

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

    ISO 11040-4:2015 Prefilled syringes Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
    ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
    ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications Part 20: Common test methods
    EN ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016)
    EN ISO 80369-6 : 2016 COR 2016 SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS (ISO 80369-6:2016, CORRECTED VERSION 2016-11-15)
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    EN ISO 80369-1:2010 Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)
    ISO 8638:2010 Cardiovascular implants and extracorporeal systems Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    ISO 10241-2:2012 Terminological entries in standards — Part 2: Adoption of standardized terminological entries
    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
    ISO 527-2:2012 Plastics — Determination of tensile properties — Part 2: Test conditions for moulding and extrusion plastics
    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 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
    ISO 8536-4:2010 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
    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 10241-1:2011 Terminological entries in standards — Part 1: General requirements and examples of presentation
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
    ISO 178:2010 Plastics Determination of flexural properties
    ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
    EN 13544-2:2002+A1:2009 Respiratory therapy equipment - Part 2: Tubing and connectors
    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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