Appareils électromédicaux - Partie 2-39: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de dialyse péritonéale

Scope

Replacement:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PERITONEAL DIALYSIS ME EQUIPMENT as defined in 201.3.208, hereafter referred to as PD EQUIPMENT. It applies to PD EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including PD EQUIPMENT operated by the PATIENT, regardless of whether the PD EQUIPMENT is used in a hospital or domestic environment.

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 can also be applied to PD EQUIPMENT used for compensation or alleviation of disease, injury or disability.

These particular requirements do not apply to the DIALYSING SOLUTION, or the DIALYSING SOLUTION CIRCUIT.

201.1.2 Object

Replacement:

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for PD EQUIPMENT as defined in 201.3.208.

201.1.3 Collateral standards

Addition:

This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 2 of this particular standard. The requirements of IEC 60601-1-3 and IEC 60601-1-8 do not apply to this standard