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  • CEI UNI EN ISO 13485 : 2012

    Current The latest, up-to-date edition.

    MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2012

    Publisher:  Comitato Elettrotecnico Italiano

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    Table of Contents - (Show below) - (Hide below)

    European foreword
    Annex ZA (informative) - Relationship between this European
             Standard and the Essential Requirements of EU Directive
             90/385/EEC (as amended)
    Annex ZB (informative) - Relationship between this European
             Standard and the Essential Requirements of EU Directive
             93/42/EEC (as amended)
    Annex ZC (informative) - Relationship between this European
             Standard and the Essential Requirements of EU Directive
             98/79/EC

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

    Committee CT 62
    Development Note Supersedes CEI EN 46001 (01/2003) Classificazione CEI 62-229. Supersedes CEI UNI EN ISO 13488. (08/2011) Italian translation of 6ED 2016 Issued on 01/01/2017. (02/2017) 5ED 2012 Edition is valid until 31-03-2019. ERRATA 2017 Issued on 01/11/2017 is only available in English. (01/2018)
    Document Type Standard
    Publisher Comitato Elettrotecnico Italiano
    Status Current
    Supersedes
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