• 17/30325386 DC : 0

    NA Status of Standard is Unknown

    BS ISO 18250-1- CONNECTORS FOR RESERVOIR DELIVERY SYSTEMS - PART 1: GENERAL REQUIREMENTS AND COMMON TEST METHODS

    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 Materials used for RESERVOIR CONNECTORS
    5 Requirements for RESERVOIR CONNECTORS
      for specific APPLICATIONS
    6 Alternative RESERVOIR CONNECTORS for
      APPLICATIONS not already covered in this series
      of Standards
    7 Common TEST METHODS for RESERVOIR CONNECTORS
    8 PROCEDURE to assess a proposed new design of
      RESERVOIR CONNECTOR for inclusion in this series of
      Standards
    Annex A (informative) - Rationale
    Annex B (normative) - TEST METHODS for
            demostrating NON-INTERCONNECTABLE
            characteristics
    Annex C (normative) - Positive pressure liquid leakage
            TEST METHOD
    Annex D (normative) - Subatmospheric-pressure air leakage
            TEST METHOD
    Annex E (normative) - Stress cracking TEST METHOD
    Annex F (normative) - Resistance to separation from axial load
            TEST METHOD
    Annex G (normative) - Resistance to separation from
            unscrewing TEST METHOD
    Annex H (normative) - Resistance to overriding
            TEST METHOD
    Annex I (normative) - Disconnection by unscrewing
            TEST METHOD for floating or rotating screw thread
            locking CONNECTORS and locking CONNECTORS
            with fixed threads
    Annex J (informative) - Modification of the TEST METHODS
            to generate variable data for statistical Analysis
    Annex K (informative) - Common CONNECTOR geometries
            and functioning
    Annex L (informative) - Examples of MEDICAL DEVICES
            on which RESERVOIR CONNECTORS may be used
            for each APPLICATION category
    Annex M (informative) - Reference to the Essential
            Principles
    Annex N (informative) - Alternative mechanical TEST METHODS
    Annex O (informative) - Terminology - Alphabetized index
            of defined terms
    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 527-2:2012 Plastics — Determination of tensile properties — Part 2: Test conditions for moulding and extrusion plastics
    CR 13825:2000 Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings"
    ISO 16269-6:2014 Statistical interpretation of data — Part 6: Determination of statistical tolerance intervals
    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 5479:1997 Statistical interpretation of data — Tests for departure from the normal distribution
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 178:2010 Plastics Determination of flexural properties
    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 527-1:2012 Plastics Determination of tensile properties Part 1: General principles
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