Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment

Clause 1 of the general standard1 applies, except as follows:

201.1.1 Scope

Replacement:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of GAMMA BEAM THERAPY EQUIPMENT, including MULTI-SOURCE STEREOTACTIC RADIOTHERAPY 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.

201.1.2 Object

Replacement:

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for GAMMA BEAM THERAPY EQUIPMENT.