EN 60601-2-64:2015

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Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment

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Published date: 28-05-2015

Publisher: European Committee for Standards - Electrical

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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 of 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
201.101 ELECTRONIC IMAGING DEVICES (EID)
206 Usability
Annexes
Annex B (informative) - Sequence of testing
Annex I (informative) - ME SYSTEMS aspects
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)

IEC 60601-2-64:2014 applies to the basic safety and essential performance of Light Ion Beam Medical Electrical equipment, hereafter referred to as ME equipment, used for treatment of patients. This particular standard, with the inclusion of type tests and site tests, applies respectively to the manufacture and some installation aspects of ME equipment intended for radiotherapy in human medical practice, including those in which the selection and display of operating parameters can be controlled automatically by programmable electronic subsystems, that, in normal use, deliver a radiation beam of light ions having energy per nucleon in the range 10 MeV/n to 500 MeV/n.Key words: nuclear medicine, radiation dosimetry.

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Committee	CLC/TC 62
Document Type	Standard
ISBN
Pages
Published
Publisher	European Committee for Standards - Electrical
Status	Current

National Adoptions - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
BS EN 60601-2-64:2015	Identical
NBN EN 60601-2-64 : 2015	Identical
PN EN 60601-2-64 : 2015	Identical
CEI EN 60601-2-64 : 2016	Identical
I.S. EN 60601-2-64:2015	Identical
NEN EN IEC 60601-2-64 : 2015	Identical
NF EN 60601-2-64 : 2015	Identical
SN EN 60601-2-64:2015	Identical
UNE-EN 60601-2-64:2015	Identical
VDE 0750-2-64 : 2018	Identical
DIN EN 60601-2-64 : 2018	Identical

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

I.S. EN IEC 62667:2018	MEDICAL ELECTRICAL EQUIPMENT - MEDICAL LIGHT ION BEAM EQUIPMENT - PERFORMANCE CHARACTERISTICS
BS EN IEC 62667:2018	Medical electrical equipment. Medical light ion beam equipment. Performance characteristics
EN IEC 62667:2018	Medical electrical equipment - Medical light ion beam equipment - Performance characteristics

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

EN 61217:2012	Radiotherapy equipment - Coordinates, movements and scales
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 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
ISO/IEC 14165-321:2009	Information technology Fibre Channel Part 321: Audio-Video (FC-AV)
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 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
IEC 61217:2011	Radiotherapy equipment - Coordinates, movements and scales
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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