• ANSI/AAMI/ISO 80369-6:2016

    Current The latest, up-to-date edition.

    SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  15-03-2016

    Publisher:  Association for the Advancement of Medical Instrumentation

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

    Glossary of equivalent standards
    Committee representation
    Background of ANSI/AAMI/ISO 80369-6:2016
    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

    Abstract - (Show below) - (Hide below)

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

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

    Development Note Supersedes AAMI CN6. (11/2017)
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    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
    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 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
    ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications
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