ISO 1135-4:2015 pdf download.Transfusion equipment for medicaluse —Part 4: Transfusion sets for single use，gravity feed.
5.4.4 When rested in accordance with ISO 3826-1:2013, 5.3. the connection between the closurepiercing device and Lhe blood bag port shall show no evidence of leakage.
5.5 Tubing
5.5.1 The tubing, made of flexible material, shall be transparent or sufficiently translucent so that the interface of air and water during the passage of air bubbles can be observed with normal or corrected-to- normal vision.
5.5.2 The tubing from the distal end to the drip chamber shall be not less than I 500 mm in length, including the injection site, when provided, and the male conical fitting.
5.6 Filter for blood and blood components
The transfusion set shall be provided with a filter for blood and blood components. The filter shall have uniform pores and shall cover a total area of not less than 10 cm2. When tested in accordance with A.3 the mass of solid material retained on the filter shall be not less than 80 % (mass fraction) of that retained on the reference filter. If the filter has a confined thread diameter of( 100 ± 10 ) and a pore size of [200 ± 20) pm, with a single warp and a single welt. a filtration performance test can be exempted.
Pore size measurement can be performed by microscopic inspection.
5.5 Tubing
5.5.1 The tubing, made of flexible material, shall be transparent or sufficiently translucent so that the interface of air and water during the passage of air bubbles can be observed with normal or corrected-to- normal vision.
5.5.2 The tubing from the distal end to the drip chamber shall be not less than I 500 mm in length, including the injection site, when provided, and the male conical fitting.
5.6 Filter for blood and blood components
The transfusion set shall be provided with a filter for blood and blood components. The filter shall have uniform pores and shall cover a total area of not less than 10 cm2. When tested in accordance with A.3 the mass of solid material retained on the filter shall be not less than 80 % (mass fraction) of that retained on the reference filter. If the filter has a confined thread diameter of( 100 ± 10 ) and a pore size of [200 ± 20) pm, with a single warp and a single welt. a filtration performance test can be exempted.
Pore size measurement can be performed by microscopic inspection.
