BS EN ISO 8536-4:2020 pdf download
BS EN ISO 8536-4:2020 pdf download.Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed.
3 Terms and definitions
No terms and definitions are listed in this document.
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4 General requirements
4.1 The nomenclature to be used for components of infusion sets and of a stand-alone air-inlet device is given in Figures 1. Z and . These figures illustrate examples of the configuration of infusion sets and air-inlet devices; other configurations may be used provided they lead to the same results. Infusion sets
5 Designation
Designation shall follow label requirements according to Clause 10.
6 Materials
The materials from which the infusion set, its components and the stand-alone air-inlet device are manufactured (as described in Clause 4) shall comply with the requirements specified in Clause_7. Where components of the infusion set come into contact with solutions, the materials shall also comply with the requirements specified in Clauses 8 and 9.
7 Physical requirements
7.1 Particulate contamination
The infusion set and stand-alone air-inlet device shall be manufactured under conditions that minimize particulate contamination. All parts shall be smooth and clean at the fluid pathway surfaces. When tested as specified in Al, the number of particles shall not exceed the contamination index limit.
7.2 Leakage
The infusion set, when tested in accordance with A3.., shall show no signs of air leakage.
7.3 Tensile strength
When tested as specified in 4, the infusion set, excluding protective caps, shall withstand a static tensile force of not less than 15 N for 15 s.
8 Chemical requirements
8.1 Reducing (oxidizable) matter
When tested in accordance with 2. the difference of volume of Na2S2O3 solution Iconcentration of
Na2S2O3 = 0,005 mol/lJ for the extract solution S1 and of volume of Na2S2O3 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 pg/mI of barium, chromium, copper, lead and tin, and not more than 0,1 pg/mI of cadmium, when determined by atomic absorption spectroscopy (AAS) or an equivalent method.
When tested in accordance with 3. the intensity ol the colour produced in the test solution shall not exceed that of the standard matching solution with a concentration of Pb2 = I pg/mI.
8.3 Titration acidity or alkalinity
When tested in accordance with 8.4. not more than 1 ml of either standard volumetric solution shall be required for the indicator to change to the colour grey.
9 Biological requirements
9.1 General
The infusion set and the stand-alone air-inlet aevice snail be assessea ror oioiogical comparlolilty according to the guidelines given in C2.
9.2 Sterility
The infusion set and the stand-alone air-inlet device in its unit container shall have been subjected to a validated sterilization process, e.g. Iso 11135, Iso 11137-1, 150 11137-2 and ISO 17665.
9.3 Pyrogenicity
The infusion set and the stand-alone air-inlet device shall be assessed for freedom from pyrogens by using a suitable test. The test result shall indicate that the infusion set and stand-alone air-inlet device are free from pyrogens. Guidance on testing for pyrogenicity is given in Ci..
9.4 Haemolysis
The infusion set shall be assessed for freedom from haemolytic constituents. The test result shall indicate that the infusion set is free from haemolytic reactions. Guidance on testing for haemolytic constituents is given in ISO 10993-4.
9.5 Toxicity
Materials shall be assessed for toxicity by carrying out suitable tests. The test results shall indicate freedom from toxicity. Guidance on testing for toxicity is given in ISO 10993-1.
10 Labelling
10.1 General
The labelling shall include the requirements as specified in 1Q2 and 1OJ. If graphical symbols are used, then refer to ISO 15223-1.BS EN ISO 8536-4 pdf download.
