IEC 62083:2000 pdf download

IEC 62083:2000 pdf download.Medical electrical equipment – Requirements for the safety of radiotherapy treatment planning systems.
IEC 60788. Medical radiology — Term inology
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 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 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 CO4PATIBILITY, are not included in this standard. SAFETY 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 slandards
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.
4 Terminology and definitions
For the purpose of this International Standard, the following terms and definitions apply, in addition to the index of defined terms listed in annex C.
EQUIPMENT MODELEQUIPUENT MODELLING
all physical, geometric and RADIATION parameters required to plan a course of RADIOTHERAPY for parlicular EQUIPMENT. The process of establishing the EQUIPMENT MODEL Is referred to as
EOUIPMENT MODELLING
4.2
BRACHYTHERAPY SOURCE MODEL BRACHYTHERAPY SOURCE MODELLING
all physical, geometric and RADIATION parameters required to plan a course of RADIOTHERAPY for a particular BRACHYTHERAPY RADIOACTIVE SOURCE. The process of establishing the BRACI-IYTHERAPY SOURCE MODEL is referred to as BRACHYTHERAPY SOURCE MODELLING
4.3
PATiENT ANATOMY MODEL’ANATOMY MODELLING
all physical and anatomical parameters required 10 plan a Course of RADIOTHERAPY for a particular PATIENT. The process of establishing the PATIENT ANATOMY MODEL Is referred to as ANATOMY MODELLING”
4.4
TREATMENT PLANITREATUENT PLANNING
all PATIENT and dosimetric information that is intended for use by appropriately QUALIFIED PERSONS for the purpose of prescribing or administering RADIOTHERAPY treatment. A TREATMENT PLAN includes inlormation transmitted to other EQUIPMENT for which the use of the information for prescribing or administering IRRADIATION 5 indirect. A printed or plotted TREATMENT PLAN 5 referred to as a TREATMENT PLAN report
4.5
RADIOTHERAPY TREATMENT PLANNING SYSTEM (RTPS)
a device, usually a PROGRAMMABLE ELECTRONIC SYSTEM including its associated peripherals, that is used to simulate the application of RADIATION to a PATIENT for a proposed RADIOTHERAPY treatment. It usually, but not necessarily, provides estimations of ABSORBED DOSE distribution in human tissue using a particular algorithm or algorithms. These algorithms provide simulations of RADIATION that is typically from, but not necessarily limited to. MEDICAL ELECTRON ACCELERATORS, GAMMA BEAM THERAPY EQUIPMENT. 01 RADIOACTIVE SOURCES when BRACHYTHERAPY Is
planned.
5 General requirements for tests
5.1 Testing during development
Compliance with IEC 60601•1•4 requires Identification of HAZARDS, assessment of their RiSKS, and appropriate verification and validation of RISK controls. Demonstration of compliance with the requirements of this standard shall be inCluded as part of the above processes, with explicit reference to each requirement. Compliance data shall be retained by the MANUFACTURER as a permanent record, each test shall include a protocol containing all the necessary input data, sufficient detail to provide for exact reproducibility, and the expected result. A summary description of the tests performed to demonstrate compliance to each clause and subclause of this standard shall be included in the technical description.
5.2 Testing during installation
The MANUFACTURER shall provide an installation test document as part of the technical description that includes, as a minimum, performance of the ABSORBED DOSE distribution calculation algorithm tests given in 11.2. The tests shall also demonstrate correct functioning of the RTPS hardware components and their ability to achieve predetermined results when performing TREATMENT PLANNING functions.