Skip to content
Please enter a keyword to search

  • CEI EN 82304-1 : 1ED 2018

    Current The latest, up-to-date edition.

    HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  13-05-2018

    Publisher:  Comitato Elettrotecnico Italiano

    Add To Cart

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

    FOREWORD
    INTRODUCTION
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 HEALTH SOFTWARE PRODUCT
      requirements
    5 HEALTH SOFTWARE - Software
      life cycle processes
    6 HEALTH SOFTWARE PRODUCT
      VALIDATION
    7 HEALTH SOFTWARE PRODUCT
      identification and ACCOMPANYING
      DOCUMENTS
    8 Post-market activities for the
      HEALTH SOFTWARE PRODUCT
    Annex A (informative) - Rationale
    Bibliography
    Annex ZA (normative) - Normative references
                           to international publications
                           with their corresponding
                           European publications

    Abstract - (Show below) - (Hide below)

    Describes the SAFETY and SECURITY of HEALTH SOFTWARE PRODUCTS designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for MANUFACTURERS.

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

    Committee TC 62
    Development Note Classificazione CEI 62-253. (05/2018)
    Document Type Standard
    Publisher Comitato Elettrotecnico Italiano
    Status Current
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective