YY/T 0321.3-2022Single-use filter for anaesthesia (English PDF)

5.1 Appearance

Observed with normal vision or corrected vision, the outer surface of the filter shall be smooth and free of burrs, impurities, cracks and other defects.

5.2 Joints

Filter joints shall meet the requirements of GB/T 1962.1 and/or GB/T 1962.2.

5.3 Filtration performance requirements

5.3.1 Filtration performance requirements for fluid filters with a nominal pore size of 2.0 µm When testing according to A.1 in Appendix A, the filtration rate of the fluid medicine filter shall not be less than 90%.

5.3.2 Filtration performance requirements for fluid filters with a nominal pore size of 0.22 µm The 0.22 µm fluid filter shall be tested according to the bubble point pressure test method specified in Chapter 6 of YY/T 0929.1-2014.

Note: The 0.22 µm fluid filter shall meet the requirements of YY/T 0918 for bacterial retention test. Due to the complexity of the bacterial retention test, it is generally not suitable for routine inspection. Routine inspection can use the integrity test for fluid filters specified in YY/T 0929.1, provided that the specified lower limit of the bubble point pressure has established a relationship with the bacterial retention test specified in YY/T 0918.

5.3.3 Air filter filtration performance requirements

When testing the air filter according to A.2, the filtration rate of particulates greater than or equal to 0.5 µm in the air shall not be less than 90%.

5.4 Tightness

5.4.1 When the fluid filter is tested according to A.3.1, there shall be no liquid leakage.

5.4.2 When the air filter is tested according to A.3.2, there shall be no gas leakage.

5.5 Particle contamination

When the fluid filter is determined for particle contamination by the test in A.4 or other equivalent methods, the number of particles >=5.0 µm in the 60 mL eluent shall not exceed 100/mL.

5.6 Liquid flow

5.6.1 Under the pressure of 300 kPa of fluid filter with a nominal pore size of 2.0 µm, the 0.9% sodium chloride injection flowing through the fluid filter within 1 min shall not be less than 200 mL.

5.6.2 Under the pressure of 300 kPa of fluid filter with a nominal pore size of 0.22 µm, the 0.9% sodium chloride injection flowing through the fluid filter within 1 min shall not be less than 100 mL.

6.1 Preparation method of test solution

See Appendix B for the test solution preparation method.

6.2 Reducing substance (readily oxidizable substance)

When testing according to 5.2.2 in GB/T 14233.1-2008, the difference in the volume of the potassium permanganate solution [c (KMnO4 = 0.002 mol/L] consumed by the test solution and the blank solution shall not exceed 2.0 mL.

6.3 Metal ions

When testing according to 5.6.1 in GB/T 14233.1-2008, the color of the test solution shall not exceed the standard control solution with a mass concentration rho(Pb2+) = 1 µg/mL.

When using the atomic absorption spectrophotometry (AAS) in GB/T 14233.1-2008 or an equivalent method, the total content of barium, chromium, copper, lead and tin in the test solution shall not exceed 1 µg/mL, and the content of cadmium shall not exceed 0.1 µg/mL.

6.4 Limits for acidity and alkalinity

e) words "single-use", or equivalent instructions, or graphic symbols conforming to

YY/T 0466.1;

f) words "sterile" and "sterilization method", or graphic symbols conforming to

YY/T 0466.1;

g) words such as "damaged package, prohibited use" and "destroy after use", or graphic symbols conforming to YY/T 0466.1;

h) residual amount of liquid medicine in the fluid filter;

i) nominal pore size of the filtering medium.

8.2 Shelf or multi-unit packaging

Shelf packs or multi-unit packs (if used) shall have at least the following information:

a) manufacturer and/or distributor name and address;

b) product name, model, specifications;

c) batch number or production date, or graphic symbols conforming to YY/T 0466.1;

d) expiration date (year and month), with appropriate text attached, or graphic symbols conforming to YY/T 0466.1;

e) words "single-use", or equivalent instructions, or graphic symbols conforming to

YY/T 0466.1;

f) words "sterile" and "sterilization method", or graphic symbols conforming to

YY/T 0466.1;

g) number of filters;

h) recommended storage conditions (if any).

A.2 Air filter filtration rate test

A.2.1 Test equipment

Dust particle counter: the length of the sampling tube is 1 m. The sampling frequency is 1 time/min.

Rotor flow meter: range 60 mL/min, 80 mL/min or 100 mL/min.

A.2.2 Test steps

Under static environmental conditions, connect the dust particle counter to the flow meter; measure the number of particles >= 0.5 µm in the air collected within 1 min at an air flow rate of 50 mL/min; read 5 data continuously.

Take another air filter and connect it to the air inlet of the flowmeter according to the direction of use. Under the same air flow rate, measure the number of particles >= 0.5 µm in the air flowing through the air filter within 1 minute; read 5 data continuously.

Remove the maximum and minimum values of the 5 consecutively read data, and take the average value of the remaining 3 data.

A.2.3 Result expression

Formula (A.2) gives the filtration rate of the air filter, expressed as a percentage: Where:

N1 - the average number of particles >= 0.5 µm in the air flowing through the air filter;

N0 - the average number of particles >= 0.5 µm in the air.

A.3 Tightness test

A.3.1 Tightness test of fluid filter

Inject distilled water from the liquid inlet end of the fluid filter; close the other end; apply a pressure of 300 kPa; observe for 15 seconds, and there shall be no liquid leakage. Air filter filtration rate

A.3.2 Air filter tightness test

Inject gas from the inlet end of the air filter at a pressure of 80 kPa; close the other end.

Immerse the air filter in water at 20 °C ~ 30 °C and observe for 15 s. There shall be no gas leakage.

A.4 Particle contamination test

A.4.1 Principle

By flushing the inner cavity of the fluid filter, collect the particles in the eluate of the fluid filter, and count them to evaluate pollution.

A.4.2 Test equipment

Particle counter: including resistance method or light resistance method, provided with a stirring system, the sampling volume at a time is not less than 1 mL.

A.4.3 Flushing solution

Water for injection or purified water or sodium chloride injection with a mass concentration of 9 g/L, filtered through a microporous membrane with a pore size of 0.2 µm.

A.4.4 Pretreatment

Fill the test fluid filter with the liquid in accordance with A.4.3 and soak it for 1 h at room temperature.

A.4.5 Procedure

Take 60 mL of flushing solution; use a syringe to inject it into the pretreated liquid filter; flow it into the sample pool of a clean counter to obtain the eluent. Count the particles larger than or equal to 5.0 µm in the eluate in the sample pool, and the total sampling volume shall not be less than 15 mL.

A.4.6 Result expression

Report the result by the content of particles in the eluate (pcs/mL).