Biological Performance

Sterilization

Pyrogen

Pyrogen-free

Chemical Performance

Reducing Material

0.005mol/L Sodium thiosulfate Consumption Difference ≤2.0mL

Titration acidity or alkalinity

Volume of required sodium hydroxide standard solution or hydrochloric acid standard solution≤1ml

Ultraviolet Absorption

≤0.1

Residue on Evaporation

The total amount of dry residue shall not exceed 5 mg

EO Remnants

No more than 0.5mg for each set

Physical Performance

Particulate contamination

Contamination index limit N≤90

Leakage test

Immerse the set with one end blocked in water at (40±1)℃ and apply pressure of 20KPa for 15s; fill the set with degassed, distilled water, subject it to an internal excess pressure of -20KPa at (40±1)℃ for 15s, air leakage shall not be observed.

Tensile strength

Connection between components, protective jacket excluded, should be able to withstand a static force of not less than 15N for 15s.

Closure-piercing device

Pierce and penetrate closure of a fluid container without pre-piercing, no coring should occur.

Air Filter

Air filter rate ≥90％,Flow reduction by air filter＜20%

Soft Tube

Tube should be transparent or sufficiently translucent, when bubbles pass by, normal or corrected eyesight is able to observe air and water interface.

Liquid Filter Rate

Liquid filter rate≥80％

Volume Tolerance

Tolerance on capacity greater than half of nominal capacity should be ± 4% of expelled volume.

Flow Regulator

Flow regulator can be used without damaging the tube during an infusion, and no deleterious reactions occur when stored with tube.

Flow Rate

Under 1m static head, for 20 drops/ml drip chamber, the infusion set shall deliver not less than 1000ml of sodium chloride solution (ρ=9g/L) within 10min; for 60 drops/ml drip chamber, the infusion set shall deliver not less than 1000ml of sodium chloride solution within 40min.