NBN EN 62083 : 2010
Current
The latest, up-to-date edition.
MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS
12-01-2013
1 Scope and object
2 Normative references
3 Relationship to other standards
3.1 Hardware SAFETY standards
3.2 Software SAFETY standards
3.3 IEC 61217 Radiotherapy equipment -
Coordinates, movements and scales
4 Terminology and definitions
5 General requirements for tests
5.1 Testing during development
5.2 Testing during installation
6 ACCOMPANYING DOCUMENTS
7 General requirements for operational safety
7.1 Distances and linear dimensions
7.2 RADIATION quantities
7.3 Date and time format
7.4 Protection against unauthorized use
7.5 Data limits
7.6 Protection against unauthorized modification
7.7 Correctness of data transfer
7.8 Coordinate systems and scales
7.9 Saving and archiving data
8 RADIOTHERAPY TREATMENT EQUIPMENT and
BRACHYTHERAPY SOURCE MODELLING
8.1 General
8.2 Dosimetric information
8.3 EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL
acceptance
8.4 EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL
deletion
9 ANATOMY MODELLING
9.1 Data acquisition
9.2 Coordinate systems and scales
9.3 Contouring of regions of interest
9.4 PATIENT ANATOMY MODEL acceptance
9.5 PATIENT ANATOMY MODEL deletion
10 TREATMENT PLANNING
10.1 General requirements
10.2 TREATMENT PLAN preparation
10.3 TREATMENT PLAN identification
10.4 TREATMENT PLAN deletion
10.5 Electronic signatures
11 ABSORBED DOSE distribution calculation
11.1 Algorithms used
11.2 Accuracy of algorithms
12 TREATMENT PLAN report
12.1 Incomplete TREATMENT PLAN report
12.2 Information on the TREATMENT PLAN report
12.3 Transmitted TREATMENT PLAN information
13 General hardware diagnostics
14 Arithmetic processor
15 Data and code
16 Human errors in software design
17 Change in software versions
18 Human errors in use
Annex A (normative) Hardware safety
A.1 General requirements
A.2 Completeness of hardware SAFETY
A.3 Completeness of ACCOMPANYING DOCUMENTS
Annex B (informative) Imported and exported data
Annex C (normative) Terminology - Index of defined
terms
Annex ZA (normative) Normative references to
international publications with their
corresponding European publications
Applicable to design, manufacture and installation of RTPS for use in RADIOTHERAPY TREATMENT PLANNING in human medical practice, import of data either through input by OPERATOR or directly from other devices and output data either in printed form or directly to other devices. It is meant for NORMAL USE by OPERATORS having required skills and training, maintained as recommended in INSTRUCTIONS FOR USE and used within the environmental and electrical supply conditions specified in technical description.
DocumentType |
Standard
|
PublisherName |
Belgian Standards
|
Status |
Current
|
Standards | Relationship |
DIN EN 62083:2011-01 | Identical |
SN EN 62083 : 2001 | Identical |
IEC 62083:2009 | Identical |
UNE-EN 62083:2010 | Identical |
BS EN 62083:2009 | Identical |
EN 62083:2009 | Identical |
I.S. EN 62083:2009 | Identical |
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