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BS EN 62083:2009

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

Published date

31-03-2010

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).

IEC 62083:2009 applies to the design, manufacture and some installation aspects of a radiotherapy treatment planning systems:
- for use in radiotherapy treatment planning in human medical practice;
- that imports data either through input by the operator or directly from other devices;
- that outputs data either in printed form for review or directly to other devices;
and which is intended to be:
a) for normal use, under the authority of appropriately licensed or qualified persons, by operators having the required skills and training;
b) maintained in accordance with the recommendations given in the instructions for use, and
c) used within the environmental and electrical supply conditions specified in the technical description.
This second edition replaces the first edition of IEC 62083, published in 2000. This edition constitutes a technical revision, which brings this standard in line with changes to the other standards referred to in this standard.

Committee
CH/62/3
DevelopmentNote
Supersedes 98/564808 DC. (08/2001)
DocumentType
Standard
Pages
36
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
DIN EN 62083:2011-01 Identical
NBN EN 62083 : 2010 Identical
IEC 61300-2-12:2005 Identical
NF EN 62083 : 2010 Identical
UNE-EN 62083:2010 Identical
SN EN 62083 : 2001 Identical
EN 62083:2009 Identical
IEC 62083:2009 Identical
I.S. EN 62083:2009 Identical

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IEC 61000-4-4 : 3.0EN+(REDLINE+VERSION) ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-4: TESTING AND MEASUREMENT TECHNIQUES - ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST
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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)
IEC 61000-4-4:2012 RLV Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test
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
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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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