International Electrotechnical Commission

Medical electrical equipment   Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment - Edition 2.0
 N 60601-2-17

Annotation

Addition:

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-controlled AFTERLOADING EQUIPMENT

– 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).