T/NBPIA 002-2020 Quality technical specifications for dialysate used in hemodialysis and online preparation of replacement fluid

Scope

Scope: This standard specifies the sampling sites, sampling frequency, and quality requirements for dialysis solution; measures to improve the quality of dialysis solution or online replacement solution; requirements for handling abnormal dialysis solution quality; requirements for sampling, storage, sending for testing, and detection methods of dialysis solution; and quality inspection of dialysis solution in hemodialysis rooms. This standard is suitable for all levels and types of medical institutions and independently established hemodialysis centers (dialysis rooms) regarding the quality requirements for dialysis solution and online prepared replacement solution. This standard does not apply to replacement solution for continuous renal replacement therapy and peritoneal dialysis solution. Main technical content: This document stipulates (1) the standards that dialysis water used for preparing dialysis solution and replacement solution should meet. (2) Sampling sites, sampling timing, sampling frequency, and quality requirements for low-flux dialysis solution. (3) Sampling sites, sampling timing, sampling frequency, and quality requirements for high-flux dialysis solution. (4) Quality requirements for online prepared replacement solution. (5) Measures to further reduce the degree of microbial contamination in dialysis solution or replacement solution. (6) Solutions when the concentration of bacteria, endotoxins, or electrolytes exceeds the standard. (7) Items for inspection of the management of dialysis solution or replacement solution in hemodialysis rooms.

Development Information

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