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  • 14/30302761 DC : 0

    NA Status of Standard is Unknown

    BS ISO 11249 - MECHANICAL CONTRACEPTIVES - GUIDANCE FOR CLINICAL EVALUATION OF INTRA-UTERINE CONTRACEPTIVE DEVICES (IUDS)

    Available format(s):  Hardcopy, PDF

    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 Planning an IUD trial - Good clinical practice
    5 Ethics
    6 Clinical Investigation Plan
    7 Identification and description of the investigational device
    8 Preliminary investigations and justification for the design of
       the clinical investigation
    9 Objectives and hypotheses of the clinical investigation
    10 Design of the clinical investigation
    11 Adverse events, adverse device effects and non-medical
       complaints
    12 Early termination or suspension of the clinical investigation
    13 Publication policy
    Annex A (informative) - Exclusion and inclusion criteria for IUD
            trials
    Annex B (informative) - Timing of insertion of IUD: When can an
            IUD be inserted?
    Bibliography

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

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

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

    MEDDEV 2.12-1 : REV 8 : 2013 GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO/TS 19218:2005 Medical devices Coding structure for adverse event type and cause
    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
    MEDDEV 2.12-2 : REV 2012 POST MARKET CLINICAL FOLLOW-UP STUDIES - A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 7439:2015 Copper-bearing contraceptive intrauterine devices — Requirements and tests
    ISO 15225:2016 Medical devices Quality management Medical device nomenclature data structure
    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
    ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
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