• ANSI/AAMI/ISO 80369-20:2015

    Current The latest, up-to-date edition.

    SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 20: COMMON TEST METHODS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  20-04-2015

    Publisher:  Association for the Advancement of Medical Instrumentation

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

    Glossary of equivalent standards
    Committee representation
    Background of AAMI/ISO 80369-20:2015
    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)

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

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

    Document Type Test Method
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current

    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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