• NEN EN ISO 14155 : 2011 C1 2011

    Current The latest, up-to-date edition.

    CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE

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    Published date:  12-01-2013

    Publisher:  Netherlands Standards

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    Abstract - (Show below) - (Hide below)

    Defines good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.

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    Development Note Supersedes NEN EN ISO 14155-1 and NEN EN ISO 14155-2. (02/2011) Corrigendum 1 was cancelled on 7 March, 2012. (09/2012)
    Document Type Standard
    Publisher Netherlands Standards
    Status Current
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