| Customization: | Available |
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| Type: | Disposable Product |
| Material: | PVC |
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| Specification | Requirements |
| Physical requirements | |
| Particulate contamination | All parts shall be smooth and clean at the fluid pathway surfaces. When tested as specified in EN ISO 1135-4 A.1, the number of particles detected shall not exceed the contamination index limit. |
| Leakage | The transfusion set shall show no signs of air leakage. |
| Tensile strength | Any connections between the components of the transfusion set, excluding protective caps, shall withstand a static tensile force of not less than 15 N for 15 s. |
| Closure-piercing device | The dimensions of the closure-piercing device shall conform to the dimensions shown in figure 3. The closure-piercing device shall be capable of piercing and penetrating the closure of a container for blood and blood components without prepiercing. No coring should occur during this procedure. When inserted into a blood bag port conforming to ISO 3826-1, the closure-piercing device shall resist a pull force of 15 N for 15 s. The connection between the closure-piercing device and the blood bag port shall show no evidence of leakage. |
| Tubing | 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-tonormal vision. The tubing from the distal end to the drip chamber shall be not less than 1 500 mm in length, including the injection site, when provided, and the male conical fitting. |
| Filter for blood and blood components | The transfusion set is 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. The mass of solid material retained on the filter shall be not less than 80 % (mass fraction) of that retained on the reference filter. |
| 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 tube shall be such that 20 drops of distilled water at (23 ± 2) °C and at a flow rate of (50 ± 10) drops/min deliver (1 ± 0,1) ml [(1 ± 0,1) g]. The drip chamber should permit and facilitate the procedure of priming. |
| Flow regulator | The flow regulator shall adjust the flow of the blood and blood components between zero and maximum. The flow regulator should be 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. |
| Flow rate of blood and blood components | The transfusion set shall deliver not less than 1 000 ml of blood at (23 ± 2) °C in 30 min with a pressure difference of 10 kPa. The transfusion set shall also deliver not less than 500 ml of blood in 2 min under a pressure of 30 kPa above atmospheric pressure. The blood shall be collected into a suitable anticoagulant solution and stored for not less than 2 weeks, and be free of large clots. |
| Injection site | The self-sealing injection site shall reseal, and there shall be no leakage of more than one falling drop of water. The injection site should be located near the male conical fitting. |
| Male conical fitting | The distal end of the tubing shall terminate in a male conical fitting conforming with EN 20594-1. Luer lock fittings in accordance with EN 20594-1 is used. |
| Protective caps | The protective caps at the end of the transfusion set shall maintain the sterility of the closure-piercing device, the male conical fitting and the interior of the transfusion set. Protective caps should be secure but easily removable. |
| Chemical requirements | |
| Reducing (oxidizable) matter | When tested in accordance with EN ISO 1135-4 B.2, the total amount of potassium permanganate solution [c(KMnO4) = 0,002 mol/l] used shall not exceed 2,0 ml. |
| Metal ions | The extract shall not contain in total more than 1 μg/ml of barium, chromium, copper, lead and tin, and not more than 0,1 μg/ml of cadmium, when determined by atomic absorption spectroscopy (AAS) or an equivalent method. When tested in accordance with EN ISO 1135-4 B.3, the intensity of the colour produced in the test solution shall not exceed that of the standard matching solution containing β (Pb2+) = 1 μg/ml. |
| Titration acidity or alkalinity | When tested in accordance with EN ISO 1135-4 B.4, not more than 1 ml of either standard volumetric solution shall be required for the indicator to change to the colour grey. |
| Residue on evaporation | When tested in accordance with EN ISO 1135-4 B.5, the total amount of dry residue shall not exceed 5 mg. |
| UV absorption of extract solution | When tested in accordance with EN ISO 1135-4 B.6, the extract solution S1 shall not show absorption greater than 0,1. |
| Biological requirements | |
| General | The transfusion set shall not release any substances which may adversely affect the patient. |
| Sterility | The transfusion set in its unit container shall have been subjected to a validated sterilization process. |
| 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. |
| Haemolysis | The transfusion set shall be assessed for freedom from haemolytic constituents and the result shall indicate that the transfusion set is free from haemolytic reactions (EN ISO 10993-4). |
| Toxicity | Materials shall be assessed for toxicity by carrying out suitable tests and the results of the tests shall indicate freedom from toxicity (EN ISO 10993). |
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