• BS EN ISO 80369-20:2015

    Current The latest, up-to-date edition.

    Small-bore connectors for liquids and gases in healthcare applications Common test methods

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  30-06-2015

    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 Test methods for small-bore connectors
    Annex A (informative) - Rationale and guidance
    Annex B (normative) - Leakage by pressure decay
            test method
    Annex C (normative) - Falling drop 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
    Annex J (informative) - Modification of the test methods to
            generate variable data for statistical analysis
    Annex K (informative) - Terminology - alphabetized index of
            defined terms
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines the TEST METHOD to evaluate the performance requirements for SMALL-BORE CONNECTORS specified in the ISO 80369- series.

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

    Committee CH/210/5
    Development Note Supersedes 13/30282550 DC. (06/2015)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    ISO/IEC TR 10000-1:1998 Information technology Framework and taxonomy of International Standardized Profiles Part 1: General principles and documentation framework
    ISO 10241-2:2012 Terminological entries in standards — Part 2: Adoption of standardized terminological entries
    ISO 16269-6:2014 Statistical interpretation of data — Part 6: Determination of statistical tolerance intervals
    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 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
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