What is BS EN 60601-2-39 - Particular requirements for peritoneal dialysis equipment about?
BS EN 60601 is a European standard that discusses medical electrical equipment. BS EN 60601-2-39 outlines the basic safety and essential performance of peritoneal dialysis medical electrical equipment as defined in 201.3.208, hereafter referred to as peritoneal dialysis equipment to ensure the practical degree of safety in the operation of peritoneal dialysis equipment.
BS EN 60601-2-39 applies to peritoneal dialysis equipment intended for use either by medical staff or under the supervision of medical experts, including peritoneal dialysis equipment operated by the patient, regardless of whether the peritoneal dialysis equipment is used in a hospital or domestic environment.
BS EN 60601-2-39 can also be applied to PD EQUIPMENT used for compensation or alleviation of disease, injury, or disability.
N ote: These requirements do not apply to the dialysing solution or the dialysing solution circuit.
Who is BS EN 60601-2-39 - Particular requirements for peritoneal dialysis equipment for?
BS EN 6060...