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.
Note: 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 60601-2-39 on the particular requirements for peritoneal dialysis equipment are useful for:
- Manufacturers of peritoneal dialysis equipment
- Test centres
- Regulatory authorities
Why should you use BS EN 60601-2-39 – Particular requirements for peritoneal dialysis equipment?
Automated peritoneal dialysis medical electrical equipment is used to perform automated peritoneal dialysis (ADP). Automated peritoneal dialysis is a method to perform dialysis with automated fluid exchanges in the peritoneum.
BS EN 60601-2-39 guideline assists you with general requirements for testing of medical electrical equipment, protection against electrical hazards, protection against mechanical hazards, protection against unwanted, protection against excessive radiation hazards, protection against excessive temperatures, and much more.
This assists in achieving the basic safety and essential performance of peritoneal dialysis equipment.
BS EN 60601-2-39 also guides on the accuracy of controls, protection against hazardous outputs, hazardous situations, fault conditions, programmable electrical medical systems, and electromagnetic compatibility for peritoneal dialysis equipment.
With obedience and compliance to BS EN 60601-2-39, you can enhance the efficacy and standardise the performance of peritoneal dialysis equipment. In addition, ensures the health and safety of patients and operators.