• 15/30288418 DC : 0

    NA Status of Standard is Unknown

    BS EN ISO 80369-2 - SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 2: CONNECTORS FOR BREATHING SYSTEMS AND DRIVING GASES APPLICATIONS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Dimensional requirements for SMALL-BORE
      CONNECTORS for the respiratory APPLICATION
    6 Performance requirements
    Annex A (informative) - Rationale and guidance
    Annex B (normative) - SMALL-BORE CONNECTORS
            for BREATHING SYSTEMS and driving gases for
            respiratory use
    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 BREATHING SYSTEMS
            and driving gases for respiratory use
    Annex F (informative) - Summary of SMALL-BORE CONNECTOR
            criteria and requirements for BREATHING SYSTEMS
            and driving gases for respiratory use APPLICATIONS
    Annex G (informative) - Summary of assessment of the design
            of the SMALL-BORE CONNECTORS for BREATHING SYSTEMS
            and driving gases for respiratory use
    Annex H (informative) - Reference to the Essential Principles
    Annex I (informative) - Terminology - alphabetized index of
            defined terms
    Annex ZA (informative) - Relationship between this document and
             the Essential Requirements of EU Directive 93/42/EEC
    Bibliography

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

    Comment Closes On
    Committee CH/210/5
    Document Type Draft
    Publisher British Standards Institution
    Status NA

    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
    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 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
    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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