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  • 16/30346829 DC : 0

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BS ISO 16038 - MALE CONDOMS - GUIDANCE ON THE USE OF ISO 4074 AND ISO 23409 IN THE QUALITY MANAGEMENT CONDOMS

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-01-2018

    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 Quality of design
    5 Quality of manufacture
    6 Quality in procurement
    7 Quality in testing
    8 Important parameters to be considered
      when using ISO 4074 and ISO 23409
    9 Sampling
    Bibliography

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

    Comment Closes On
    Committee CH/157
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
    ASTM D 5712 : 2015 : REDLINE Standard Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
    ISO 16037:2002 Rubber condoms for clinical trials Measurement of physical properties
    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
    ISO 23409:2011 Male condoms Requirements and test methods for condoms made from synthetic materials
    ISO/TR 13425:2006 Guidelines for the selection of statistical methods in standardization and specification
    ISO 29941:2010 Condoms — Determination of nitrosamines migrating from natural rubber latex condoms
    ISO 2859-10:2006 Sampling procedures for inspection by attributes Part 10: Introduction to the ISO 2859 series of standards for sampling for inspection by attributes
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 4074:2015 Natural rubber latex male condoms Requirements and test methods
    ISO 80000-1:2009 Quantities and units — Part 1: General
    ISO 9001:2015 Quality management systems — Requirements
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    EN 980:2008 Symbols for use in the labelling of medical devices
    ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
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