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  • EN 15546-1 : 2008

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 1: GENERAL REQUIREMENTS

    Available format(s): 

    Superseded date:  01-01-2010

    Language(s): 

    Published date:  12-01-2013

    Publisher:  European Committee for Standards - Electrical

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Materials used for small bore connectors
    5 Small bore connector requirements for specific
      medical applications
    6 Procedure to assess proposed new small bore
      connector for inclusion in this series of Standards
      6.1 General
      6.2 Procedure to be carried out by proposer of new
          small bore connector to assess the noninterchangeability
          with existing small bore connectors
      6.3 Design review
    Annex A (informative) - Rationale for this Standard
    Annex B (informative) - Overview of small bore connector
                            allocation
    Annex C (informative) - Small bore connectors for vascular
                            systems applications
    Annex ZA (informative) - Relationship between this European
                             Standard and the Essential Requirements
                             of EU Directive 93/42/EEC Medical devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines general requirements for small bore connectors used in specific medical applications to convey liquids or gases to or from a patient or via intermediate systems.

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

    Committee TC 3
    Document Type Standard
    Publisher European Committee for Standards - Electrical
    Status Superseded
    Superseded By

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

    ISO 3040:2016 Geometrical product specifications (GPS) Dimensioning and tolerancing Cones
    CR 13825:2000 Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings"
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    EN 13014:2000/AC:2002 CONNECTIONS FOR GAS SAMPLING TUBES TO ANAESTHETIC AND RESPIRATORY EQUIPMENT
    EN 20594-1:1993/A1:1997 CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - GENERAL REQUIREMENTS
    EN 1707 : 1996 CONICAL FITTINGS WITH A 6 % (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - 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
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
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