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  • CEI EN 61082-1 : 2016

    Current The latest, up-to-date edition.

    PREPARATION OF DOCUMENTS USED IN ELECTROTECHNOLOGY - PART 1: RULES

    Available format(s):  Hardcopy, PDF

    Language(s):  English - Italian

    Published date:  01-01-2016

    Publisher:  Comitato Elettrotecnico Italiano

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

    FOREWORD
    INTRODUCTION
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Principles
    5 USABILITY ENGINEERING PROCESS
    Annex A (informative) - General guidance and rationale
    ANNEX B (informative) - Examples of possible HAZARDOUS
            SITUATIONS related to USABILITY
    Annex C (normative) - Evaluation of a USER INTERFACE OF
            UNKNOWN PROVENANCE (UOUP)
    Annex D (informative) - Types of MEDICAL DEVICE use, with
            examples
    Annex E (informative) - Reference to the essential principles
    Bibliography
    Index of defined terms
    Annex ZA (normative) - Normative references to international
             publications with their corresponding European
             publications

    Abstract - (Show below) - (Hide below)

    Defines a PROCESS for a MANUFACTURER to analyze, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY.

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

    Committee CT 3/16
    Development Note Classificazione CEI 3-36 (09/2001) Supersedes CEI 3-32 and CEI 3-33 (04/2004) Supersedes CEI EN 61082-2, CEI EN 61082-3 and CEI EN 61082-4. (11/2006)
    Document Type Standard
    Publisher Comitato Elettrotecnico Italiano
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    CEI 79-3 : 2012 ALARM SYSTEMS - PARTICULAR REQUIREMENTS FOR INTRUSION AND HOLD-UP INSTALLATIONS
    CEI 64-8/5 : 2012 LOW VOLTAGE ELECTRICAL INSTALLATIONS - PART 5: ERECTION AND SELECTION OF ELECTRICAL EQUIPMENT

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

    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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