BS EN ISO 8536-4-2020 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed

BS EN ISO 8536-4-2020 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed. 7.8 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 that 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 and a distance of not less than 20 mm between the drip tube and the fluid filter. The wall of the drip chamber shall not be closer than 5 mm to the end of the drip tube. Depending on the design, the drip tube shall be such that 20 drops or 60 drops of distilled water at (23 ± 2) °C at a flow rate of(50 ± 10) drops/mm deliver a volume of(1 ± 0,1) ml or a mass of (1 ± 0,1) g. The drip chamber should permit and facilitate the priming procedure. 7.9 Flow regulator The flow regulator shall be in accordance with ISO 8536-13 or ISO 8536-14. 7.10 Flow rate of infusion set The infusion set without the use of an air-inlet device shall deliver not less than 1 000 ml of a sodium chloride solution [concentration of NaCI = 9 g/l] in 10 mm for a drip tube that delivers 1 ml with 20 drops. Testing shall be done in accordance with A.5J.. 7.11 Injection site When provided, the self-sealing injection site shall reseal when tested in accordance with Al and there shall be no leakage of water. The injection site should be located near the male conical fitting. 7.12 Male conical fitting The distal end of the tubing shall terminate in a male conical fitting in accordance with ISO 80369-7. 7.13 Protective caps The protective caps shall cover the respective surfaces of the infusion equipment to prevent contamination from surrounding environment, to avoid stick injuries and packaging damages. Protective caps should be secure but easily removable. 8 Chemical requirements 8.1 Reducing (oxidizable) matter When tested in accurdaiie with B2. the difference of volume of Na2S2O3 solution [concentration of NaZS2O3 = 0,005 mol/lJ for the extract solution S1 and of volume of NaZS2O3 solution for blank solution So shall not exceed 2,0 ml. 8.2 Metal ions The extract shall not contain in total more than 1 jig/mI of barium, chromium, copper,...