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    I.S. EN 62083:2009

    Current The latest, up-to-date edition.

    MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2009

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    FOREWORD
    INTRODUCTION
    1 Scope
    2 Normative references
    3 Terms, definitions and abbreviations
    4 General
    5 ACCOMPANYING DOCUMENTS
    6 General requirements for operational safety
    7 RADIOTHERAPY TREATMENT EQUIPMENT MODELLING and
       BRACHYTHERAPY SOURCE MODELLING
    8 ANATOMY MODELLING
    9 TREATMENT PLANNING
    10 ABSORBED DOSE distribution calculation
    11 TREATMENT PLAN report
    12 General hardware diagnostics
    13 Data and code
    14 Human errors in software design
    15 Change in software versions
    16 USE ERRORS
    Annex A (normative) - Hardware safety
    Annex B (informative) - Imported and exported data
    Bibliography
    Index of defined terms
    Annex ZA (normative) - Normative references to international
             with their corresponding European publications
    Annex ZZ (informative) - Coverage of Essential Requirements
             of EC Directives

    Abstract - (Show below) - (Hide below)

    Pertains to the design, manufacture and some installation aspects of a radiotherapy treatment planning systems (RTPS).

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

    Development Note For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current

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

    IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV Information technology equipment - Safety - Part 1: General requirements
    EN 61217:2012 Radiotherapy equipment - Coordinates, movements and scales
    EN 61000-4-1:2007 Electromagnetic compatibility (EMC) - Part 4-1: Testing and measurement techniques - Overview of IEC 61000-4 series
    IEC 61000-4-4 : 3.0EN+(REDLINE+VERSION) ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-4: TESTING AND MEASUREMENT TECHNIQUES - ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST
    IEC 61000-4-1:2006 Electromagnetic compatibility (EMC) - Part 4-1: Testing and measurement techniques - Overview of IEC 61000-4 series
    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
    EN 60950-1:2006/A2:2013 INFORMATION TECHNOLOGY EQUIPMENT - SAFETY - PART 1: GENERAL REQUIREMENTS (IEC 60950-1:2005/A2:2013, MODIFIED)
    EN 61000-4-2:2009 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
    EN 62304:2006/A1:2015 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015)
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    EN 61000-4-3 : 2006 AMD 2 2010 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-3: TESTING AND MEASUREMENT TECHNIQUES - RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD IMMUNITY TEST
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
    IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
    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 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
    IEC 61217:2011 Radiotherapy equipment - Coordinates, movements and scales
    EN 61000-4-4:2012 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-4: TESTING AND MEASUREMENT TECHNIQUES - ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST (IEC 61000-4-4:2012)
    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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