When applying for the registration of dialysate concentrate for hemodialysis, the following should be concerned in the product test report:
- As long as one of the following four factors is different, a full performance test report which comply with product technology requirement should be provided respectively: the final ion concentration of the dialysate, the composition and proportions of chemical raw materials of single agent of AB agents, the supply status of the dialysate concentrate, and the concentration ratio of the concentrate and the water for dialysis.
- If the product is supplied as a concentrated liquid, a full performance test report of the dialysis water used in production which comply with (the Industry Standard) YY 0572 should be provided.
- In the application for the online use of dry powder B, test report should be provided according to the applicable dialysis machine models specified in the IFU, different packaging forms provided as well as the clinical use. The reports should include the test reports for relevant indicators of the dialysate prepared by mixing with A agent at least four time points (at the beginning of dialysis, the two time points for three equal division of the clinical use duration, at the end of dialysis).
