IEC 62083 pdf download – Medical electrical equipment – Requirements for the safety of radiotherapy treatment planning systems
1 Scope and object This International Standard applies to the design, manufacture and some installation aspects of an 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 , by OPERATORS 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 technical description. An RTPS developed by a USER for its own use exclusively is not within the scope of this standard, but it is highly recommended that the principles of this standard be applied in its creation and use.
If such an RTPS is provided to another USER in which the developers do not directly control its use, and is represented as being suitable for use, then the developers assume the role of MANUFACTURER , and this standard applies. An RTPS is principally a software application, and the object of this standard is to establish the 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 the nature of the hardware. See 3.1 and annex A for hardware requirements.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of IEC and ISO maintain registers of currently valid International 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 – 2. Collateral 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 61000-4-1，Electromagnetic compatibility(EMC) – Part 4-1: Testing and measurementtechniques – overview of lEc 61000-4 series
IEC 61000-4-2，Electromagnetic compatibility (EMC) – Part 4-2: Testing and measurementtechniques – Eiectrostatic discharge immunity test
IEC 61000-4-3，Electromagnetic compatibility (EMC) – Part 4-3: Testing and measurementtechniques – Radiated, radio-frequency, electromagnetic field immunity test
IEC 61000-4-4，Electromagnetic compatibility (EMC) – Part 4: Testing and measurementtechniques – Section 4:Electrical fast transient/burst immunity test. Basic EMC PublicationIEC 61217，Radiotherapy equipment – Coordinates, movements and scales
ICRU report 42:1987: Use of Computers in External Beam Radiotherapy Procedures with highEnergy Photons and Electrons
3Relationship to other standards3.1 Hardware sAFETY standards
Requirements for the SAFETY of hardware,such as for protection against electric shock andfire，and to assure for ELECTROMAGNETIC COMPATIBILITY,are not included in this standard.SAFETY requires that these subjects be addressed by the MANUFACTURER separately throughcompliance with an appropriate standard,depending upon the nature and environment of thehardware used for the RTPs. See annex A for hardware SAFETY standards.
3.2Software SAFETY standards
An RTPs is principally a software application for a medical purpose.IEC Collateral Standard 60601-1-4 applies (see clause 16).
3.3IEC 61217 Radiotherapy equipment – Coordinates, movements and scales
IEC 61217 gives guidance on the designation of EQUIPMENT movements, the marking of scales,their zero position and the direction of movement with increasing value. The means of applyingIEC 61217 are specified in appropriate clauses and subclauses of this standard.
4Terminology and definitions
For the purpose of this International Standard，the following terms and definitions apply，inaddition to the index of defined terms listed in annex c.
4.1
EQUIPMENT MODEL/EQUIPMENT MODELLING
all physical, geometric and RADIATION parameters required to plan a course of RADIOTHERAPYfor particular EQUIPMENT.The process of establishing the EQuiIPMENT MODEL is referred to as”EQuIPMENT MODELLING”
IEC 62083 pdf download – Medical electrical equipment – Requirements for the safety of radiotherapy treatment planning systems
