EN 60601-2-64:2015
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
29-05-2015
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
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.
| Committee |
CLC/TC 62
|
| DocumentType |
Standard
|
| PublisherName |
European Committee for Standards - Electrical
|
| Status |
Current
|
| Standards | 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 |
| PNE-FprEN 60601-2-64 | Identical |
| 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 |
| 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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