• 14/30277509 DC : 0

    NA Status of Standard is Unknown

    BS ISO 18250-3 - CONNECTORS FOR RESERVOIR DELIVERY SYSTEMS - PART 2: ENTERNAL 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)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirement
    5 Dimensional requirements for ENTERAL
      feed reservoir CONNECTORS
    6 Performance requirements
    Annex A (informative) - Rationale and guidance
    Annex B (normative) - RESERVIOR CONNECTORS for access port
            on ENTERAL feeding sets and PATIENT interfaces
    Annex C (informative) - Reference CONNECTORS
    Annex D (informative) - Assessment of MEDICAL DEVICES and their
            attributes with CONNECTIONS within this application
    ANNEX E (informative) - Summary of the usability requirements for
            RESERVIOR CONNECTORS for ENTERAL APPLICATIONS
    ANNEX F (informative) - Summary of RESERVIOR CONNECTOR criteria
            and requirements for ENTERAL APPLICATIONS
    Annex G (informative) - Summary of assessment of the design of
            the CONNECTORS for ENTERAL APPLICATIONS
    Annex H (informative) - Reference to the Essential Principles
    Bibliography
    Terminology - Alphabetized index of defined terms
    Annex ZA (informative) - Relationship between the document
             and the Essential Requirements of EU Directive 93/42/EEC

    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)

    EN 1618 : 1997 CATHETERS OTHER THAN INTRAVASCULAR CATHETERS - TEST METHODS FOR COMMON PROPERTIES
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 10241-2:2012 Terminological entries in standards — Part 2: Adoption of standardized terminological entries
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    CR 13825:2000 Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings"
    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
    EN 1615 : 2000 ENTERAL FEEDING CATHETERS AND ENTERAL GIVING SETS FOR SINGLE USE AND THEIR CONNECTORS - DESIGN AND TESTING
    ISO 10241-1:2011 Terminological entries in standards — Part 1: General requirements and examples of presentation
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ASTM D 638 : 2014 : REDLINE Standard Test Method for Tensile Properties of Plastics
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