Medical electrical equipment — Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment

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

201.1.1 Scope

Replacement:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LIGHT ION BEAM ME EQUIPMENT, hereafter referred to as ME EQUIPMENT, used for treatment of PATIENTS.

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.

This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the manufacture and some installation aspects of LIGHT ION BEAM ME EQUIPMENT

– intended for RADIOTHERAPY in human medical practice, including those in which the selection and DISPLAY of operating parameters can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS)

– that, in NORMAL USE, deliver a RADIATION BEAM of LIGHT IONS having ENERGY PER NUCLEON in the range 10 MeV/n to 500 MeV/n

and

– 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 maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE

– subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON.

NOTE 1 In this particular standard, all references to installation refer to installation in the RESPONSIBLE ORGANIZATION’S premises.

NOTE 2 In this particular standard, all references to ABSORBED DOSE refer to ABSORBED DOSE in water.

NOTE 3 Information regarding x-ray image guidance can be found in IEC 60601-2-68 (under development).

NOTE 4 IEC 61217 gives guidance on the designation of ME EQUIPMENT movements, the marking of scales, their zero positions and the direction of movement with increasing value (see 201.7.4.101).