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  • CEI UNI EN 46003 : 2001

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9003

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  01-07-2020

    Language(s):  Italian

    Published date:  01-01-2001

    Publisher:  Comitato Elettrotecnico Italiano

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    Abstract - (Show below) - (Hide below)

    FASC 6085 La norma specifica, le prescrizioni relative ai sistemi qualità per l'ispezione e la prova finale dei dispositivi medici, esclusi i dispositivi medici per la diagnostica in vitro e i dispositivi medici impiantabili, e puo essere applicata nel momento in cui il sistema qualità di un fornitore di dispositivi medici sia ritenuto conforme alle prescrizioni legislative.

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

    Committee CT 62
    Development Note Classificazione CEI 62-117 (07/2001)
    Document Type Standard
    Publisher Comitato Elettrotecnico Italiano
    Status Withdrawn

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

    EN 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
    EN 724 : 1994 GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR NON-ACTIVE MEDICAL DEVICES
    ISO 8402:1994 Quality management and quality assurance — Vocabulary
    EN ISO 9003:1994/AC:1997 QUALITY SYSTEMS - SPECIFICATION FOR FINAL INSPECTION AND TEST
    EN 50103 : 1995 GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR THE ACTIVE (INCLUDING ACTIVE IMPLANTABLE) MEDICAL DEVICE INDUSTRY
    EN 46002 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
    ISO 9003:1994 Quality systems Model for quality assurance in final inspection and test
    EN ISO 8402 : 1995 QUALITY MANAGEMENT AND QUALITY ASSURANCE - VOCABULARY
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