GB 9706.216-2021 Active
GB 9706.216-2021 Medical electrical equipment—Part 2-16:Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
Abstract
This part of GB 9706 applies to the basic safety and basic performance of hemodialysis, hemodialysis filtration, and blood filtration equipment (hereinafter referred to as hemodialysis equipment).
This part does not consider the specific safety details of the dialysate control system or the central dialysate supply system of hemodialysis equipment that uses recyclable dialysate, but it does consider the specific safety requirements of such hemodialysis equipment for electrical safety and patient safety.
This part specifies the minimum safety requirements for hemodialysis equipment. These hemodialysis equipment are intended to be used under medical supervision by medical staff, patients, or other trained personnel.
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Active |
| Standard Code | GB 9706.216-2021 |
| CCS | Extracorporeal circulation, artificial organs, and prosthetic devices |
| ICS | Blood transfusion, infusion, and injection equipment |
| Implement Date | 2023-05-01 |