• 09/30173644 DC : 0

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    BS EN ISO 80369-1 - SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-07-2011

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Materials used for small-bore connectors
    5 Requirements for small-bore connectors for
      specific applications
      5.1 Small-bore connector incompatibility
      5.2 Intravascular or hypodermic applications
      5.3 Breathing systems and driving gases applications
      5.4 Enteral applications
      5.5 Urethral and urinary applications
      5.6 Limb cuff inflation applications
      5.7 Neuraxial applications
      5.8 Alternative small-bore connectors
    6 Procedure to assess a proposed new design of
      small-bore connector for inclusion in this
      series of Standards
      6.1 General
      6.2 Proposal initiation
      6.3 Procedure to assess acceptability and
          non-interconnectable characteristics
          6.3.1 Design
          6.3.2 Design realization
          6.3.3 Design verification
          6.3.4 Design validation
      6.4 Design review
      6.5 Subsequent parts of this series of Standards
    Annex A (informative) - Rationale
    Annex B (normative) - Mechanical tests for verifying
            non-interconnectable characteristics
    Annex C (informative) - Applications of small-bore connectors
    Annex D (informative) - Reference to the Essential Principles
    Annex ZA (informative) - Relationship between this Document
             and the Essential Requirements of EU Directive
             93/42/EEC
    Bibliography
    Terminology - Alphabetized index of defined terms

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

    Comment Closes On
    Committee CH/84/-/1
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    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 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    CR 13825:2000 Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings"
    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
    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 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
    ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications
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