IEC 62083:2000 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 measurement
techniques – Overview of IEC 61000-4 series
IEC 61000-4-2, Electromagnetic compatibility (EMC) – Part 4-2: Testing and measurement
techniques – Electrostatic discharge immunity test
IEC 61000-4-3, Electromagnetic compatibility (EMC) – Part 4-3: Testing and measurement
techniques – Radiated, radio-frequency, electromagnetic field immunity test
IEC 61000-4-4, Electromagnetic compatibility (EMC) – Part 4: Testing and measurement
techniques – Section 4: Electrical fast transient/burst immunity test. Basic EMC Publication
IEC 61217, Radiotherapy equipment – Coordinates, movements and scales
ICRU report 42:1987: Use of Computers in External Beam Radiotherapy Procedures with high
Energy Photons and Electrons
3 Relationship to other standards
3.1 Hardware SAFETY standards
Requirements for the SAFETY of hardware, such as for protection against electric shock and
fire, and to assure for ELECTROMAGNETIC COMPATIBILITY , are not included in this standard.
S AFETY requires that these subjects be addressed by the MANUFACTURER separately through
compliance with an appropriate standard, depending upon the nature and environment of the
hardware used for the RTPS . See annex A for hardware SAFETY standards.
3.2 Software SAFETY standards
An RTPS is principally a software application for a medical purpose.
IEC Collateral Standard 60601-1-4 applies (see clause 16).
3.3 IEC 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 applying
IEC 61217 are specified in appropriate clauses and subclauses of this standard.
IEC 62083:2000 pdf download
