The TS EN 60601-2-39 standard, developed by the International Electrotechnical Commission (IEC), an organization affiliated to the International Standards Organization (ISO), describes the features and test methods for the safety and performance of peritoneal dialysis devices among electrical medical devices. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN IEC 60601-2-39 Electrical medical devices - Part 2-39: Certain features for the basic safety and mandatory performance of peritoneal dialysis devices.
The mentioned standard applies to the basic safety and performance of peritoneal dialysis electrical medical equipment. Peritoneal dialysis equipment may be used in a hospital, healthcare facility, or home environment. This standard applies to peritoneal dialysis equipment intended for use by medical personnel or under the supervision of medical professionals, including patient-operated peritoneal dialysis equipment.
Peritoneal dialysis device works by using the body's peritoneal membrane and dialysate fluid exchange to filter and clean blood. These changes are made manually during the day or using a peritoneal dialysis machine used as a cycler at night. Peritoneal dialysis using a machine is called continuous cycle peritoneal dialysis or automatic peritoneal dialysis.
Hazards inherent in the intended physiological function of medical equipment or physical systems covered by this standard are not covered by the requirements of this standard.
The standards referred to as normative in the application of this standard are: IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8 and IEC 60601-1-11.
Within the scope of laboratory services, our organization also provides safety and performance testing services of peritoneal dialysis devices, which are among electrical medical devices, in the TS EN 60601-2-39 standard.
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