T/NBPIA 007-2021 Active Group standards

T/NBPIA 007-2021 Blood dialysis device clinical performance classification

Publish Date: 2021-12-15 Implement Date: 2021-12-31 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/NBPIA 007-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medicine

ICS Name: Other medical equipment

Publish Date: 2021-12-15

Implement Date: 2021-12-31

Scope

Main technical content: 1. Classify hemodialysis filters into low-flux, high-flux, medium-retention, and high-retention filters based on the performance parameters measured according to the methods specified in T/NBPIA 005.1, T/NBPIA 005.2, and T/NBPIA 005.5. 2. Low-flux filters refer to those that meet the following criteria during in vitro testing: MWRO > 2.0 kDa and ≤ 5.0 kDa, and MWCO > 10.0 kDa and ≤ 25.0 kDa. In clinical use, they exhibit ultrafiltration coefficients < 20 mL/(mmHg·hr), β2-microglobulin clearance rates < 20 mL/min, negligible YKL-40 clearance, and minimal albumin loss. 3. During in vitro testing, MWRO > 5.0 kDa and ≤ 9.0 kDa, and MWCO > 25.0 kDa and ≤ 55.0 kDa. In clinical use, they exhibit ultrafiltration coefficients > 20 mL/(mmHg·hr), β2-microglobulin clearance rates > 20 mL/min, YKL-40 clearance rates < 20 mL/min, and average albumin loss of < 1.0 g per hemodialysis session. 4. During in vitro testing, MWRO > 9.0 kDa and ≤ 12.5 kDa, and MWCO > 55.0 kDa and ≤ 110.0 kDa. In clinical use, they exhibit ultrafiltration coefficients > 20 mL/(mmHg·hr), β2-microglobulin clearance rates > 20 mL/min, YKL-40 (or solutes with similar properties and molecular weight) clearance rates ≥ 20 mL/min, and average albumin loss of < 4.0 g per hemodialysis session (maximum ≤ 6.7 g). 5. During in vitro testing, MWRO and MWCO exceed 12.5 kDa and 110.0 kDa, respectively. In clinical use, they exhibit ultrafiltration coefficients > 20 mL/(mmHg·hr), β2-microglobulin clearance rates > 20 mL/min, YKL-40 (or solutes with similar properties and molecular weight) clearance rates > 20 mL/min, and average albumin loss of > 4.0 g per hemodialysis session (maximum ≥ 6.7 g).