Medical Electrical Equipment - Peritoneal Dialysis Equipment HS: 9018909918; Other medical equipment (ICS 11.040.99)

National Standard of the P.R.C., Medical Electrical Equipment - Part 2-39: Particular Requirements for Basic Safety and Essential Performance of Peritoneal Dialysis Equipment (23 page(s), in Chinese)

This part applies to the basic safety and essential performance of PD ME equipment defined in 201.3.208, hereinafter referred to as PD equipment. This standard applies to PD equipment intended to be used by medical personnel or under the supervision of medical experts, including patient-operated PD equipment used in hospitals or in a home environment.