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  • BIP 0113 : 2012

    Current The latest, up-to-date edition.

    GUIDE TO EUROPEAN MEDICAL DEVICE TRIALS AND BS EN ISO 14155

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    Published date:  23-11-2012

    Publisher:  British Standards Institution

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    Committee ZBIP/4
    Document Type Standard
    Publisher British Standards Institution
    Status Current

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

    BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice
    BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
    MEDDEV 2.12-1 : REV 8 : 2013 GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM
    EN ISO 25539-2:2012 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
    MEDDEV 2.12-2 : REV 2012 POST MARKET CLINICAL FOLLOW-UP STUDIES - A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
    MEDDEV 2.13 : REV 1 COMMISSION COMMUNICATION ON THE APPLICATION OF TRANSITIONAL PROVISION OF DIRECTIVE 93/42/EEC RELATING TO MEDICAL DEVICES (OJ 98/C 242/05)
    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 980:2008 Symbols for use in the labelling of medical devices
    EN ISO 14630:2012 Non-active surgical implants - General requirements (ISO 14630:2012)
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