IEC 62274:2005
Current
The latest, up-to-date edition.
Medical electrical equipment - Safety of radiotherapy record and verify systems
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
English - French
27-05-2005
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 |
| CEI EN 62274 : 2005 | Identical |
| EN 62274:2005 | Identical |
| NF EN 62274 : 2005 | Identical |
| GOST R IEC 62274 : 2013 | Identical |
| UNE-EN 62274:2005 | Identical |
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