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  • UNE-EN ISO 4074:2016

    Current The latest, up-to-date edition.

    Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015)

    Available format(s):  Hardcopy, PDF

    Language(s):  Spanish, Castilian, English

    Published date:  15-06-2016

    Publisher:  Asociacion Espanola de Normalizacion

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

    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Quality verification
    5 Design
    6 Burst volume and pressure
    7 Tests for stability and shelf life
    8 Freedom from holes
    9 Visible defects
    10 Package integrity
    11 Packaging and labelling
    12 Test report
    Annexes
    A Sampling plans intended for accessing compliance of a
        continuing series of lots of sufficient number to allow the
        switching rules to be applied
    B Sampling plans intended for accessing compliance of isolated
        lots
    C Determination of total lubricant for condoms in individual
        containers
    D Determination of length
    E Determination of width
    F Determination of thickness
    G Determination of bursting volume and pressure
    H Oven treatment for condoms
    I Determination of force and elongation at break of test pieces of
        condoms
    J Determination of shelf life by real-time stability studies
    K Guidance on conducting and analysing accelerated ageing
        studies
    L Testing for holes
    M Test for package integrity
    N Calibration of air inflation equipment for determination of
        burst volume and pressure
    P Rationale
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines the minimum requirements and the test methods to be used for condoms made from natural rubber latex which are supplied to consumers for contraceptive purposes and to assist in the prevention of sexually transmitted infections.

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

    Committee CTN 111
    Development Note Supersedes UNE EN 600. (09/2005)
    Document Type Standard
    Publisher Asociacion Espanola de Normalizacion
    Status Current
    Supersedes

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

    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
    ISO 15223-2:2010 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
    ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 16038:2005 Rubber condoms Guidance on the use of ISO 4074 in the quality management of natural rubber latex condoms
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 3534-2:2006 Statistics Vocabulary and symbols Part 2: Applied statistics
    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    ASTM D 3492 : 2016 : REDLINE Standard Specification for Rubber Contraceptives (Male Condoms)
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 5893:2002 Rubber and plastics test equipment Tensile, flexural and compression types (constant rate of traverse) Specification
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
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