Comitato Elettrotecnico Italiano

Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment
 N EN 60601-2-17

Annotation

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of automatically-controlled BRACHYTHERAPY AFTERLOADING ME EQUIPMENT, hereafter referred to as ME EQUIPMENT.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME 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.

NOTE See also 4.2 of the general standard.

This standard applies to automatically-controlled BRACHYTHERAPY AFTERLOADING ME EQUIPMENT used for treatment or alleviation of disease.

This standard specifies requirements

a) for automatically-controlled AFTERLOADING ME EQUIPMENT

1) 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 AFTERLOADING ME EQUIPMENT,

2) 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,