BS EN ISO 8536-4-2020 pdf download

BS EN ISO 8536-4-2020 pdf download.Infusion equipment for medical use一 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 oldrops. The liquid shall enter the drip chamber through a tube that projects into the chamber. There shall be a distance of not less than 40mm 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 lube 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 p,’lmlng 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 Iconcentrarion of NaCl = 9 g/lJ in 10 mm for a drip tube that delivers I ml with 20 drops. Testing shall be done In accordance with A.il. 7.11 Infretion site When provided, the self-sealing Inlection site shall reseal when tested In accordance with A2 and there shall be no leakage of water. The Injection site should be located near the male conical lilting. 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 Inpuries and packaging damages. Protective caps should be secure but easily removable. 8 Chemical requirements 8.1 Red ucl,sg (oxidizable) matter When tested In accordance with 8.2.. the difference of volume of Na2S2O3 solution Iconcentratlon of Na2S1Oi = 0.005 mol/iJ for the extract solution S, and of volume of Na2S2Oa solution for blank solution S0 shall not exceed 2,0 ml. 8.2 Metal Ions The extract shall not contain In total more than 1 pg/mI of barium, chromium, copper, lead...