YY/T 1288-2015Nylon blood filter nets for transfusion equipments for single use (English PDF)

3.1 Structure type of filter net

See Figure 1 for the example of typical bracket filter net structure. See Figure 2 for the example of typical bag filter net (without fixed bracket) structure.

3.2 Marking

The marking example of the filter net is as follow. welding firmness according to the specific conditions.

5.4 Particulate pollution

The filter net shall be made under conditions of minimum particulate contamination. When tested according to Annex A, the pollution index shall not exceed 90.

5.5 Filtration performance

When tested according to Annex B, the rejection of the filter net to 240µm particles shall not be less than 95%, not less than 95% to 160µm particles.

NOTE: If tested, the test filter net is organized as a single warp single weft. And when the wire diameter conforms to 100µm±10µm, and the aperture conforms to 200µm±20µm, it can be exempt from the filter performance test.

5.6 Melting peak temperature

When tested according to the method specified in GB/T 19466.3, the monofilament melting peak temperature (melting point) of the filter net made of nylon 66 monofilament shall be in the range of 246°C ~ 257°C (475°F ~ 495°F); the monofilament melting peak temperature (melting point) of the filter net made of nylon 1010 monofilament shall be in the range of 198°C ~ 210°C (388°F ~ 410°F).

NOTE: It can also be measured using other validated equivalent test methods.

6.1 Preparation of chemical test liquid

Take several samples and add them to a glass container. Add water in a ratio of 2.1 to the total surface area (cm2) and water (mL) of the sample. After capping, place it at 37°C±1°C for 24h. Separate the sample from the liquid. Cool to room temperature. Use it as inspection liquid. Take the same volume of water in the glass container and prepare a blank control solution.

6.2 Reducing substance

When tested according to the provisions of 5.2.2 of GB/T 14233.1-2008, the difference between the volume of 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 ion

9.1 Initial packaging marks

The product's initial packaging shall have the following marks.

a) manufacturer's name and/or trademark, address, contact information;

b) product name and specification model;

c) material and organization of filter net;

d) quantity;

e) product effective date;

f) batch number;

g) reference to this Standard.

9.2 Outer packaging mark

The outer packaging shall have the following marks.

a) manufacturer's name and/or trademark, address, contact information;

b) product name and specification model;

c) material and organization of filter net;

d) net weight, gross weight, quantity;

e) volume (length x height x width);

f) product effective date;

g) batch number;

h) reference to this Standard; […]