• ISO 4074:2015

    Current The latest, up-to-date edition.

    Natural rubber latex male condoms Requirements and test methods

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  French, English

    Published date:  15-10-2015

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 4074:2015 specifies requirements and test methods for male condoms made from natural rubber latex.

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

    Development Note Supersedes ISO 4074-1, ISO 4074-2, ISO 4074-3, ISO 4074-4, ISO 4074-5, ISO 4074-6, ISO 4074-7, ISO 4074-8, ISO 4074-9 and ISO 4074-10. (06/2002) Supersedes ISO/FDIS 4074. (10/2015)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    07/30169357 DC : 0 BS ISO 25841 - FEMALE CONDOMS - REQUIREMENTS AND TEST METHODS
    15/30302532 DC : 0 BS ISO 19671 - ADDITIONAL LUBRICANTS FOR CONDOMS - EFFECT ON CONDOM STRENGTH
    09/30195717 DC : 0 BS ISO 29942 - PROPHYLACTIC DAMS - REQUIREMENTS AND TEST METHODS
    08/30133979 DC : DRAFT MAY 2008 BS ISO 23409 - MALE CONDOMS - REQUIREMENTS AND TEST METHODS FOR CONDOMS MADE FROM SYNTHETIC MATERIALS
    DIN ISO 29941 E : 2014 CONDOMS - DETERMINATION OF NITROSAMINES MIGRATING FROM NATURAL RUBBER LATEX CONDOMS (ISO 29941:2010)
    ISO 25841:2017 Female condoms — Requirements and test methods
    ASTM D 7160 : 2016 : REDLINE Standard Practice for Determination of Expiration Dating for Medical Gloves
    ISO 29943-1:2017 Condoms — Guidance on clinical studies — Part 1: Male condoms, clinical function studies based on self-reports
    15/30303073 DC : 0 BS ISO 25841 - FEMALE CONDOMS - REQUIREMENTS AND TEST METHODS
    BS ISO 29943-1:2017 Condoms. Guidance on clinical studies Male condoms, clinical function studies based on self-reports
    ISO 16038:2017 Male condoms — Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
    16/30346829 DC : 0 BS ISO 16038 - MALE CONDOMS - GUIDANCE ON THE USE OF ISO 4074 AND ISO 23409 IN THE QUALITY MANAGEMENT CONDOMS
    BS ISO 25841:2017 Female condoms. Requirements and test methods
    14/30296392 DC : 0 BS ISO 29943-1 - CONDOMS - GUIDANCE ON CLINICAL STUDIES - PART 1: MALE CONDOMS, CLINICAL FUNCTION STUDIES BASED ON SELF-REPORTS
    BS ISO 16038:2017 Male condoms. Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
    BS ISO 23409:2011 Male condoms. Requirements and test methods for condoms made from synthetic materials
    ISO 16037:2002 Rubber condoms for clinical trials Measurement of physical properties
    ASTM D 3492 : 2016 : REDLINE Standard Specification for Rubber Contraceptives (Male Condoms)
    BS ISO 29941:2010 Condoms. Determination of nitrosamines migrating from natural rubber latex condoms
    BS ISO 29942:2011 Prophylactic dams. Requirements and test methods
    ISO 29942:2011 Prophylactic dams — Requirements and test methods
    ISO 23409:2011 Male condoms Requirements and test methods for condoms made from synthetic materials
    09/30195714 DC : 0 BS ISO 29941 - CONDOMS - DETERMINATION OF NITROSAMINES MIGRATING FROM NATURAL RUBBER LATEX CONDOMS INTO VARIOUS MEDIA
    DIN ISO 29941:2014-12 Condoms - Determination of nitrosamines migrating from natural rubber latex condoms (ISO 29941:2010)
    ISO 29941:2010 Condoms — Determination of nitrosamines migrating from natural rubber latex condoms

    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)
    ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
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