IEC 62083 pdf download

IEC 62083 pdf download Medical electrical equipment — Requirements for the safety of radiotherapy treatment planning systems
This International Standard applies to the design, manufacture and some installation aspects ofan RTPS
– for use in RADIOTHERAPY TREATMENT PLANNING in human medical practice;
– that imports data either through input by the OPERATOR or direct from other devices;- that outputs data either in printed form for review or direct to other devices;
and which is intended to be
for NORMAL USE,under the authority of appropriately licensed or QUALIFIED PERSONs, byOPERATORs having the required skills and training;
maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and
used within the environmental and electrical supply conditions sPECIFIED in the technicaldescription.
An RTPs developed by a uSER for its own use exclusively is not within the scope of thisstandard,but it is highly recommended that the principles of this standard be applied in itscreation and use. If such an RTPs is provided to another uSER in which the developers do notdirectly control its use，and is represented as being suitable for use,then the ‘developersassume the role of MANUFACTURER,and this standard applies.
An RTPs is principally a software application，and the object of this standard is to establishthe requirements for features, associated documentation， and testing of the software.Requirements for SAFETY of hardware are not included in this standard, as they vary with thenature of the hardware.See 3.1 and annex A for hardware requirements.
Normative references
The following normative documents contain provisions which，through reference in this text,constitute provisions of this International Standard. For dated references,subsequentamendments to,or revisions of，any of these publications do not apply. However，parties toagreements based on this International Standard are encouraged to investigate the possibilityof applying the most recent editions of the normative documents indicated below.For undatedreferences, the latest edition of the normative document referred to applies. Members of lECand lso maintain registers of currently valid lnternational Standards.
IEC 60601-1,Medical electrical equipment – Part 1: General requirements for safety
IEC 60601-1-2，Medical electrical equipment – Part 1: General requirements for safety – 2Collateral Standard: Electromagnetic compatibility – Requirements and tests
IEC 60601-1-4，Medical electrical equipment – Part 1: General requirements for safety – 4.Collateral Standard: Programmable electrical medical systems
IEC 60788, Medical radiology – Terminology
IEC 60950, Safety of information technology equipment
IEC 61 000-4-1 , Electromagnetic compatibility (EMC) – Part 4-1: Testing and measurement techniques – Overview of IEC 61000-4 series
IEC 61 000-4-2, Electromagnetic compatibility (EMC) – Part 4-2: Testing and measurement techniques – Electrostatic discharge immunity test
IEC 61 000-4-3, Electromagnetic compatibility (EMC) – Part 4-3: Testing and measurement techniques – Radiated, radio-frequency, electromagnetic field immunity test
IEC 61 000-4-4, Electromagnetic compatibility (EMC) – Part 4: Testing and measurement techniques – Section 4: Electrical fast transient/burst immunity test. Basic EMC Publication
IEC 61 21 7, Radiotherapy equipment – Coordinates, movements and scales
ICRU report 42:1 987: Use of Computers in External Beam Radiotherapy Procedures with high Energy Photons and Electrons
3 Relationship to other standards
3.1 Hardware SAFETY standards