ISO 1135-4 pdf download – Transfusion equipment for medical Part 4: Transfusion sets for single use, gravity.
5.4.4 When tested in accordance with ISO 3826-I :20 13, 5.3. the connection between the closurepiercing device and the 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 hubbies 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 lilter shall have uniform pores and shall cover a total area of not less than 10 cn. 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 confirmed thread diameter of( 100 ± 10) fin: and a pore size of [200 ± 20) pm, with a single warp and a single well, a filtration performance test can he exempted.
Pore size measurement can be performed by microscopic inspection.
5.7 Drip chamber and drip tube
The drip chamber shall permit continuous observation of the fall of drops. The liquid shall enter the drip chamber through a tube which projects into the chamber. There shall be a distance of not less than 40 mm between the end of the drip tube and the outlet of the chamber, or a distance of not less than 20 mm between the drip tube and the filter for blood and blood components. The wall of the drip chamber shall not be closer than 5 mm to the end of the drip tube.
The drip chamber should permit and facilitate the procedure of priming.
5.8 Flow regLilator
The flow regulator shall adjust the flow of the blood and blood components between zero and maximum.
The flow regulator should he capable of continuous use throughout a transfusion without the tubing being damaged.
There should be no deleterious reaction between the flow regulator and the tubing when stored in such a manner that there is contact.
5.9 Flow rate of blood and blood components
7.2 Sterility
The transfusion set in its unit Container shall have been subjected to a validated sterilization process (see References
121. 131. and 141).
7.3 Pyrogenicity
The transfusion set shall be assessed for freedom from pyrogens using a suitable test and the results shall indicate that the transfusion set is free from pyrogenicity. Testing for pyrogenicity shall be carried out in accordance with Annex
C.
7.4 Haemolvsis
The transfusion set shall be assessed for freedom from huemolytic constituents and the result shall indicate that the transfusion set is free from haemolytic reactions.
NOTE Guidance on resting for haemolytic constituents is gien in ISO 10993-4.
7.5 Toxicity
Maerials shall be assessed for toxicity by carrying out suitable tests and the results of the tests shall indicate freedom from toxicity.
NOTE Guidance on testing for toxicity is given in ISO 10993-I.
7.6 Assessment of blood component depletion
Sets shall be assessed against the range of blood components for which they are recommended to ensure that no more than 5 % of the relevant constituent’s) of a single adult therapeutic dose of each blood component is retained by the set3) . The assessment should compare samples of the blood component taken prior to and after passage through the transfusion set.
NOTE For guidance. relevant constituents are typically present in the following doses or concentrations:
r e d cell components: >36 g haemoglohin per unit;
—platelet concentrate: >2,4 x I 0E platelets per unit:
f r e s Ii frozen plasma: >0.7 IU Factor VIlIc per ml.
7.7 Assessment of damage to blood components
Transfusion sets shall be assessed against the range of blood components for which Lhey are recommended to ensure that the relevant constituent’s) of each blood component is not significantly damaged (or where applicable, activated or inactivated) by passage through the set3). The assessment should compare using a validated test method, samples of the blood component taken prior to and after passage through the transfusion set.
The clinical relevance of test results should he determined by a competent accredited laborarory NOTE For guidance on suitable tests.
ISO 1135-4 pdf download – Transfusion equipment for medical Part 4: Transfusion sets for single use, gravity
