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IEC 62274:2005

Current
Current

The latest, up-to-date edition.

Medical electrical equipment - Safety of radiotherapy record and verify systems
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English - French, Spanish, Castilian

Published date

27-05-2005

Publisher

International Electrotechnical Committee

FOREWORD
INTRODUCTION
1 Scope and object
   1.1 Scope
   1.2 Object
   1.3 Relationship to other standards
2 Normative references
3 Terms and definitions
4 General requirements for tests
   4.1 Testing during development
   4.2 Testing during installation
5 ACCOMPANYING DOCUMENTS
6 Requirements for safety
   6.1 RADIATION quantities
   6.2 Date and time
   6.3 Coordinate systems and scales
   6.4 Protection against unauthorized use
   6.5 Correctness of data transfer
   6.6 Data acceptance
   6.7 Deleting and editing data
   6.8 Backing up data
   6.9 Archiving data
7 TREATMENT machine set-up verification
   7.1 Prevention of TREATMENT
   7.2 Override
   7.3 Transfer of prescribed TREATMENT data
   7.4 Accompanying information
8 TREATMENT recording and reporting
9 Accuracy
10 Abnormal operation and fault conditions
   10.1 General hardware diagnostics
   10.2 Data and code
11 Human errors in software design
12 Change in software versions
13 Human errors in use
Annex A (normative) Hardware safety
Bibliography
Index of defined terms

Applies to the design and manufacture and some installation aspects of a record and verify system (RVS) for use in radiotherapy in human medical practice that a) provides, defines, or displays treatment machine set up data; imports data either through input by the operator or directly from other devices, b) may control the ability of that equipment to operate; c) records data of all treatment sessions; and d) is intended to be: 1) for normal use, under the authority of appropriately licensed or qualified persons, by operators having the required skills and training; 2) maintained in accordance with the recommendations given in the instructions for use; and 3) used within the environmental and electrical supply conditions specified in the technical description.

Committee
TC 62/SC 62C
DevelopmentNote
Stability Date: 2020. (09/2017)
DocumentType
Standard
Pages
35
PublisherName
International Electrotechnical Committee
Status
Current

Standards Relationship
NEN EN IEC 62274 : 2005 Identical
I.S. EN 62274:2005 Identical
PN EN 62274 : 2005 Identical
BS EN 62274:2005 Identical
UNE-EN 62274:2005 Identical
CEI EN 62274 : 2005 Identical
EN 62274:2005 Identical
NF EN 62274 : 2005 Identical
GOST R IEC 62274 : 2013 Identical

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
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
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
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
NF 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

IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV Information technology equipment - Safety - Part 1: General requirements
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 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 62083:2009 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
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
IEC 60601-2-17:2013 Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment
IEC 61217:2011 Radiotherapy equipment - Coordinates, movements and scales
IEC 60601-2-29:2008 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical 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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Hardcopy - English - French
PDF - English - French
PDF 3 Users - English - French
PDF 5 Users - English - French
PDF 9 Users - English - French
Hardcopy - Spanish
PDF - Spanish
PDF 3 Users - Spanish
PDF 5 Users - Spanish
PDF 9 Users - Spanish
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