Medical electrical equipment Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
|Publication Date:||1 January 2004|
|ICS Code (Therapy equipment):||11.040.60|
|ICS Code (Non-destructive testing):||19.100|
This Particular Standard specifies requirements for the safety of automatically controlled EQUIPMENT for BRACHYTHERAPY of patients using AFTERLOADING techniques.
This Standard specifies requirements for automatically-contro
- which contains and uses only beta, gamma, and NEUTRON-emitting SEALED RADIOACTIVE SOURCES,
- which automatically drives the sealed radioactive source(s) from a storage container to a treatment position inside the source applicator(s) and returns the source(s) to the storage container,
- which is designed for connection to a PATIENT, and
- with which movements of the RADIOACTIVE SOURCE(S) are carried out automatically by the EQUIPMENT according to a prescribed programme using a powered mechanism whose changes are controlled by the CONTROLLING TIMER(S) and TIMING DEVICES that are either PROGRAMMABLE ELECTRONIC SUB-SYSTEMS (PESS) (computer or microprocessors) or non-programmable systems.
This Standard specifies requirements for EQUIPMENT intended to be
- used under the supervision of QUALIFIED PERSONS;
- maintained at predetermined intervals;
- subject to regular checks by the user.
This Standard does not specify requirements for SEALED RADIOACTIVE SOURCES used with the EQUIPMENT. Such requirements are specified in other standards (see 6.8.3).
The requirements of this Standard are based on the assumptions that:
- a TREATMENT PLAN is available that prescribes appropriate values of the TREATMENT PARAMETERS, and
- the SOURCE STRENGTH(S) of the RADIOACTIVE SOURCE(S) used by the EQUIPMENT is (are) known.
This Standard includes requirements intended to ensure that the prescribed values of the TREATMENT PARAMETERS can be achieved by the EQUIPMENT, in particular that:
- the selected RADIOACTIVE SOURCE(S) is (are) positioned or moved within the SOURCE APPLICATOR in the selected configuration relative to the SOURCE APPLICATOR;
- IRRADIATION is performed by the selected RADIOACTIVE SOURCE configuration for the selected duration;
- IRRADIATION is performed by the EQUIPMENT without causing unnecessary risk to the OPERATOR or other persons in the immediate surroundings.