IEC 60601-2-17 Remote-Controlled Automatically-Driven Gamma-Ray After-Loading Equipment Testing
Medical electrical equipment – Part 2-17: the basic safety and essential performance of automatically-controlled brachytherapy after-loading equipment
IEC 60601-2-17 Scope:
IEC 60601 2 17 and EN 60601 2 17 testing applies to the basic safety and essential performance of automatically-controlled brachytherapy after-loading medical electronic equipment, hereafter referred to as medical electronic equipment.
If a clause or sub-clause is specifically intended to be applicable to medical electronic equipment only, or to medical equipment systems only, the title and content of that clause or sub-clause will say so. If that is not the case, the clause or sub-clause applies both to medical electronic equipment and to medical equipment systems, as relevant.
Hazards inherent in the intended physiological function of medical electronic equipment or medical equipment systems within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.
IEC 60601-2-17 testing applies to automatically-controlled brachytherapy after-loading medical electronic equipment used for treatment or alleviation of disease.
EN 60601-2-17 testing specifies requirements
- For automatically-controlled after-loading medical electronic equipment
- Which contains and uses only beta, gamma, or neutron-emitting sealed radioactive sources, or brachytherapy X-ray sources designed and constructed for use with automatically-controlled after-loading medical electronic equipment,
- Which automatically drives the radiation source(s) from a storage container or, in the case of brachytherapy X-ray sources, a reference location outside the patient, to a treatment position inside the source applicator(s) and returns the radiation source(s) to the storage container or the brachytherapy X-ray source(s) to the reference location,
- Which is designed for connection to a patient, and
- With which movements of the radiation source(s) are carried out automatically by the medical electronic equipment according to a prescribed program 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 and
- For medical electronic equipment intended to be
- For normal use, operated under the authority of appropriately licensed or qualified persons by operators having the required skills for a particular medical application, for particular specified clinical purposes, e.g. remote after-loading brachytherapy;
- Maintained in accordance within the recommendations given in the instructions for use;
- Subject to regular quality assurance performance and calibration checks by a qualified person.
IEC 60601-2-17 does not specify requirements for sealed radioactive sources. Requirements for the design of X-ray tubes used with the medical electronic equipment are specified in other IEC standards. See for example: IEC 60601-2-28:2010.
The requirements of EN 60601-2-17 are based on the assumptions that:
- A treatment plan is available that prescribes appropriate values of the treatment parameters, and
- The source strength(s) or the reference air-kerma rate of the radiation source(s) used by the medical electronic equipment is (are) known. This standard includes requirements intended to ensure that the prescribed values of the treatment parameters can be achieved by the medical electronic equipment, in particular that:
- The selected radiation 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 radiation source configuration for the selected duration;
- Irradiation is performed by the medical electronic equipment without causing unnecessary risk to the operator or other persons in the immediate surroundings.
Keystone Compliance assists manufacturers with IEC 60601-2-17 and EN 60601-2-17 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-17 test lab needs.