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CEI EN 62083 : 2011

Current
Current

The latest, up-to-date edition.

MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS
Available format(s)

Hardcopy , PDF

Language(s)

English, English - Italian

Published date

01-01-2011

Publisher

Comitato Elettrotecnico Italiano

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 61000-4-4 : 3.0EN+(REDLINE+VERSION) ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-4: TESTING AND MEASUREMENT TECHNIQUES - ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST
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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Hardcopy - English
PDF - English
Hardcopy - English - Italian
PDF - English - Italian
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