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 and tin, and not more than 0.1 agJml of cadmium, when determined by atomic absorption spectroscopy (AAS) oran equivalent method.
When tested In accordance with 8.3. the intensity of the colour produced in the test solution shall not exceed that ofthe standard matching solution with a concentration of PbZ. = I iig/mi.
8.3 Titration acidity or alkalinity
When tested In accordance with 11.4. not more than I ml of either standard volumetric solution shall be required for the Indicator to change to the colour grey.BS EN ISO 8536-4 pdf download.