• CEI EN 60601-2-17 : 2016

    Current The latest, up-to-date edition.

    MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATICALLYCONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2016

    Publisher:  Comitato Elettrotecnico Italiano

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

    FOREWORD
    INTRODUCTION
    201.1 Scope, object and related standards
    201.2 Normative references
    201.3 Terms and definitions
    201.4 General requirements
    201.5 General requirements for testing ME EQUIPMENT
    201.6 Classification of ME EQUIPMENT and ME SYSTEMS
    201.7 ME EQUIPMENT identification, marking and documents
    201.8 Protection against electrical HAZARDS from ME EQUIPMENT
    201.9 Protection against MECHANICAL HAZARDS of
           ME EQUIPMENT and ME SYSTEMS
    201.10 Protection against unwanted and excessive radiation HAZARDS
    201.11 Protection against excessive temperatures and other HAZARDS
    201.12 Accuracy of controls and instruments and protection against
           hazardous outputs
    201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT
    201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
    201.15 Construction of ME EQUIPMENT
    201.16 ME SYSTEMS
    201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
    Annex A (informative) - General guidance and rationale
    Bibliography
    Index of defined terms used in this particular standard
    Annex ZA (normative) - Normative references to international
             publications with their corresponding European
             publications
    Annex ZZ (informative) - Coverage of Essential Requirements
             of EU Directives

    Abstract - (Show below) - (Hide below)

    Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of automatically-controlled BRACHYTHERAPY AFTERLOADING ME EQUIPMENT, hereafter referred to as ME EQUIPMENT.

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    Committee CT 62
    Development Note Classificazione CEI 62-40 (09/2001) 2ED 2006 Edition is valid until 14-04-2018. (02/2016) Italian translation of 3ED 2016 Issued on 01/03/2017. (04/2017)
    Document Type Standard
    Publisher Comitato Elettrotecnico Italiano
    Status Current

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

    EN 60601-2-8:2015/A1:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-8: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF THERAPEUTIC X-RAY EQUIPMENT OPERATING IN THE RANGE 10 KV TO 1 MV (IEC 60601-2-8:2010/A1:2015)
    EN 60601-2-11:2015 Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    IEC 61005:2014 Radiation protection instrumentation - Neutron ambient dose equivalent (rate) meters
    EN 61005:2017 Radiation protection instrumentation - Neutron ambient dose equivalent (rate) meters
    IEC 60601-2-8:2010+AMD1:2015 CSV Medical electrical equipment - Part 2-8: Particular requirements forthe basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
    IEC 62083:2009 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
    IEC 60601-2-1:2009+AMD1:2014 CSV Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
    EN 62083:2009 MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS
    IEC 60601-2-11:2013 Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
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