CAN/CSA-C22.2 NO. 60601-2-17-04:2004 Edition

Preface CSA

This is the second edition of CAN/CSA-C22.2 No. 60601-2-17, Medical electrical equipment – Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment, which is an adoption without modification of the identically titled CEI/IEC (Commission Électrotechnique Internationale/International Electrotechnical Commission) Standard 60601-2-17 (second edition, 2004-01).

It supersedes the previous edition, published in 1994 as CAN/CSA-C22.2 No. 601.2.17, Medical electrical equipment – Part 2: Particular requirements for the safety of remote-controlled automatically-driven gamma-ray aferloading equipment (adopted CEI/IEC 601-2-17:1989).

Scope

Addition:

1.1.101
This Particular Standard specifies requirements for the safety of automaticallycontrolled EQUIPMENT for BRACHYTHERAPY of patients using AFTERLOADING techniques.

1.1.102
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.

1.1.103
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).

1.1.104
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.