CEI EN 62083 : 2011
Current
The latest, up-to-date edition.
MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS
Hardcopy , PDF
English, English - Italian
01-01-2011
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INTRODUCTION
1 Scope
2 Normative references
3 Terms, definitions and abbreviations
4 General
5 ACCOMPANYING DOCUMENTS
6 General requirements for operational
safety
7 RADIOTHERAPY TREATMENT EQUIPMENT
MODELLING and BRACHYTHERAPY SOURCE
MODELLING
8 ANATOMY MODELLING
9 TREATMENT PLANNING
10 ABSORBED DOSE distribution calculation
11 TREATMENT PLAN report
12 General hardware diagnostics
13 Data and code
14 Human errors in software design
15 Change in software versions
16 USE ERRORS
Annex A (normative) Hardware safety
Annex B (informative) Imported and exported
data
Bibliography
Index of defined terms
Annex ZA (normative) Normative references
to international publications
with their corresponding European publications
Annex ZZ (informative) Coverage of Essential
Requirements of EC Directives
Pertains to the design, manufacture and some installation aspects of a radiotherapy treatment planning systems(RTPS).
| Committee |
CT 62
|
| DevelopmentNote |
Classificazione CEI 62-119. (11/2001)
|
| DocumentType |
Standard
|
| Pages |
38
|
| PublisherName |
Comitato Elettrotecnico Italiano
|
| Status |
Current
|
| Standards | Relationship |
| EN 62083:2009 | Identical |
| IEC 62083:2009 | Identical |
| IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV | Information technology equipment - Safety - Part 1: General requirements |
| EN 61217:2012 | Radiotherapy equipment - Coordinates, movements and scales |
| EN 61000-4-1:2007 | Electromagnetic compatibility (EMC) - Part 4-1: Testing and measurement techniques - Overview of IEC 61000-4 series |
| IEC 61000-4-1:2006 | Electromagnetic compatibility (EMC) - Part 4-1: Testing and measurement techniques - Overview of IEC 61000-4 series |
| 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 60950-1:2006/A2:2013 | INFORMATION TECHNOLOGY EQUIPMENT - SAFETY - PART 1: GENERAL REQUIREMENTS (IEC 60950-1:2005/A2:2013, MODIFIED) |
| EN 61000-4-2:2009 | Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test |
| EN 62304:2006/A1:2015 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015) |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| EN 61000-4-3 : 2006 AMD 2 2010 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-3: TESTING AND MEASUREMENT TECHNIQUES - RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD IMMUNITY TEST |
| 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 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| IEC 61000-4-2:2008 | Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test |
| IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV | Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test |
| 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 |
| EN 62366 : 2008 AMD 1 2015 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014) |
| IEC 61217:2011 | Radiotherapy equipment - Coordinates, movements and scales |
| EN 61000-4-4:2012 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-4: TESTING AND MEASUREMENT TECHNIQUES - ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST (IEC 61000-4-4:2012) |
| 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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