Appareils électromédicaux - Partie 2-17: Exigences particulières pour la sécurité de base et les performances essentielles des appareils projecteurs de sources radioactives à chargement différé automatique utilisés en brachythérapie

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 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,

3) which is designed for connection to a PATIENT, and

4) with which movements of the RADIATION SOURCE(S) are carried out automatically by the ME 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 and

 

b) for ME EQUIPMENT intended to be

 

1) 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 AFTERLOADING BRACHYTHERAPY;

2) maintained in accordance within the recommendations given in the INSTRUCTIONS FOR USE;

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

 

This Standard does not specify requirements for SEALED RADIOACTIVE SOURCES. Requirements for the design of X-RAY TUBES used with the ME EQUIPMENT are specified in other IEC standards. See for example: IEC 60601-2-28:2010.

 

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) or the REFERENCE AIR-KERMA RATE of the RADIATION SOURCE(S) used by the ME EQUIPMENT is (are) known.

 

This Standard includes requirements intended to ensure that the prescribed values of the TREATMENT PARAMETERS can be achieved by the ME 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 ME EQUIPMENT without causing unnecessary RISK to the OPERATOR or other persons in the immediate surroundings.

 

201.1.2 Object

 

Replacement:

 

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for automatically-controlled BRACHYTHERAPY AFTERLOADING ME EQUIPMENT