• IEC TR 60977:2008

    Current The latest, up-to-date edition.

    Medical electrical equipment - Medical electron accelerators - Guidelines for functional performance characteristics

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English - French

    Published date:  09-07-2008

    Publisher:  International Electrotechnical Committee

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

    FOREWORD
    INTRODUCTION
    1 Scope
    2 Normative references
    3 General, type tests
      3.1 Format of Annex A of the disclosure standard with
          suggested functional performance values
      3.2 Rationale for functional performance values suggested
          by the Working Group
          3.2.1 Introduction
          3.2.2 IEC 60976, Clause 6
          3.2.3 Suggested functional performance values
    4 Acceptance tests
      4.1 General
      4.2 Summary of suggested test methods for MEDICAL
          ELECTRON ACCELERATOR acceptance
      4.3 Acceptance test conditions
      4.4 Suggested equipment for acceptance tests and for
          subsequent periodic tests
          4.4.1 Introduction
          4.4.2 Item description
    5 Periodic tests
      5.1 Introduction
      5.2 Suggested set of periodic test methods and test
          conditions
      5.3 Suggested frequency for periodic tests during working
          life of the ELECTRON ACCELERATOR
    Bibliography

    Abstract - (Show below) - (Hide below)

    IEC/TR 60977:2008 applies to medical electron accelerators when used, for therapy purposes, in human medical practice. This technical report applies to medical electron accelerators which deliver a radiation beam of either X-radiation or electron radiation with nominal energies in the range 1 MeV to 50 MeV at maximum absorbed dose rates between 0,001 Gy s-1 and 1 Gy s-1 at 1 m from the radiation source and at normal treatment distances between 50 cm and 200 cm from the radiation source. This second edition cancels and replaces the first edition published in 1989 and its Amendment 1 (2000). It constitutes a technical revision. This second edition likewise follows on the issue of a second edition to the disclosure standard IEC 60976 in 2007. It includes the addition of performance guidelines relating to several relatively new technologies introduced within the last few years, including dynamic beam delivery techniques, such as moving beam radiotherapy, intensity modulated radiation therapy (IMRT), image guided radiotherapy (IGRT), and programmable wedge fields (PWF). Also included are stereotactic radiotherapy (SRT)/stereotactic radiosurgery (SRS) and the use of certain electronic imaging devices (EIDs).

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    Committee TC 62/SC 62C
    Development Note Stability Date: 2020. (09/2017)
    Document Type Technical Report
    Publisher International Electrotechnical Committee
    Status Current
    Supersedes

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

    BS EN 60601-2-1:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
    CSA C22.2 No. 60601.2.1 : 2011 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 61217:2012 Radiotherapy equipment - Coordinates, movements and scales
    BS EN 60601-2-68:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
    I.S. EN 60976:2007 MEDICAL ELECTRICAL EQUIPMENT - MEDICAL ELECTRON ACCELERATORS - FUNCTIONAL PERFORMANCE CHARACTERISTICS
    08/30168475 DC : DRAFT APR 2008 BS EN 60601-2-1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-1: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTRON ACCELERATORS IN THE RANGE 1 MEV TO 50 MEV
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    I.S. EN 61217:2012 RADIOTHERAPY EQUIPMENT - COORDINATES, MOVEMENTS AND SCALES (IEC 61217:2011 (EQV))
    10/30206860 DC : 0 BS EN 61217 - RADIOTHERAPY EQUIPMENT - COORDINATES, MOVEMENTS AND SCALES
    BS EN 60976 : 2008 MEDICAL ELECTRICAL EQUIPMENT - MEDICAL ELECTRON ACCELERATORS - FUNCTIONAL PERFORMANCE CHARACTERISTICS
    12/30246621 DC : 0 BS EN 60601-2-68 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY BASED IMAGE GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT
    CEI EN 60976 : 2009 MEDICAL ELECTRICAL EQUIPMENT - MEDICAL ELECTRON ACCELERATORS - FUNCTIONAL PERFORMANCE CHARACTERISTICS
    EN 60601-2-1:2015 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
    CSA C22.2 No. 60601-2-68 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT
    CSA C22.2 No. 60601.2.1 : 2011 : INC : AMD 1 : 2015 : R2016 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
    IEC 61217:2011 Radiotherapy equipment - Coordinates, movements and scales
    PD IEC TR 60788:2004 Medical electrical equipment. Glossary of defined terms
    IEC 60601-2-68:2014 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
    EN 60601-2-68:2015 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
    I.S. EN 60601-2-68:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT
    I.S. EN 60601-2-1:2015 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
    IEC 60976:2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
    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
    BS EN 61217:2012 Radiotherapy equipment. Coordinates, movements and scales
    UNE-EN 60601-2-1:2017 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 60976:2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics

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

    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60976:2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
    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
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