IEC 60601-2-39 Peritoneal Dialysis Equipment Testing
Medical electrical equipment – Part 2-39: basic safety and essential performance of peritoneal dialysis equipment
IEC 60601-2-39 Scope:
IEC 60601 2 39 and EN 60601 2 39 testing applies to the basic safety and essential performance of peritoneal dialysis medical electronic 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.
Hazards inherent in the intended physiological function of medical electronic equipment or medical equipment 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.
EN 60601-2-39 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 dialyzing solution, or the dialyzing solution circuit.
Keystone Compliance assists manufacturers with IEC 60601-2-39 and EN 60601-2-39 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-39 test lab needs.