• BS EN ISO 80369-6:2016

    Current The latest, up-to-date edition.

    Small bore connectors for liquids and gases in healthcare applications Connectors for neuraxial applications

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  28-02-2017

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Dimensional requirements for neuraxial SMALL-BORE
      CONNECTORS
    6 Performance requirements
    Annex A (informative) - Rationale and guidance
    Annex B (normative) - SMALL-BORE CONNECTORS for neuraxial
            APPLICATIONS
    Annex C (normative) - Reference CONNECTORS for testing
            SMALL-BORE CONNECTORS for neuraxial APPLICATIONS
    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 neuraxial APPLICATIONS
    Annex F (informative) - Summary of SMALL-BORE CONNECTOR
            design requirements for neuraxial APPLICATIONS
    Annex G (informative) - Summary of assessment of the design
            of the SMALL BORE CONNECTORS for neuraxial
            APPLICATIONS
    Annex H (normative) - Mechanical tests for verifying
            NON-INTERCONNECTABLE characteristics
    Annex I (informative) - Reference to the essential principles
    Annex J (informative) - Terminology - alphabetized index
            of defined terms
    Bibliography
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential
             Requirements of EU Directive 93/42/EEC

    Abstract - (Show below) - (Hide below)

    Defines requirements for SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in neuraxial APPLICATIONS.

    Scope - (Show below) - (Hide below)

    This part of ISO80369 specifies requirements for small-bore connectors intended to be used for connections in neuraxial applications. Neuraxial applications involve the use of medical devices intended to administer medications to neuraxial sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes. NOTE1 Sites for the neuraxial application include the spine, intrathecal or subarachnoid space, ventricles of the brain, and the epi-, extra-, or peri-dural space. Neuraxial application anaesthetics can be administered regionally affecting a large part of the body, such as a limb, and include plexus blocks, such as the branchial plexus blocks or single nerve blocks. Neuraxial application procedures include continuous infusion of wounds with local anaesthetic agents. NOTE2 For the purposes of this part of ISO80369, local anaesthesia injected hypodermically is not considered a neuraxial application. EXAMPLES Intended administration includes intrathecal chemotherapy, local anaesthetics, radiological contrast agents, antibiotics, analgesics. This part of ISO80369 specifies dimensions and requirements for the design and functional performance of these small-bore connectors intended to be used with medical devices. This part of ISO80369 does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular International Standards for specific medical devices or accessories. NOTE3 Manufacturers are encouraged to incorporate the small-bore connectors specified in this part of ISO80369 into medical devices, medical systems, or accessories, even if currently not required by the relevant particular medical device standards. It is expected that when the relevant particular medical device standards are revised, requirements for small-bore connectors, as specified in this part of ISO80369, will be included. Furthermore, it is recognized that standards need to be developed for many medical devices used for neuraxial applications. NOTE4 ISO80369-1:2010, 5.8, specifies alternative methods of compliance with ISO80369-1:2010, for small-bore connectors intended for use with neuraxial application medical devices or accessories, which do not comply with this part of ISO80369.

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

    Committee CH/210/5
    Development Note Supersedes 14/30288421 DC. (05/2016)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

    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
    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 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 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
    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 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
    ISO 14971:2007 Medical devices Application of risk management to 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
    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
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