BS EN ISO 8536‑4:2020 pdf – Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed.
1 Scope This document specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment. Secondary aims of this document are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components. 2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 3696, Water for analytical laboratory use — Specification and test methods ISO 7864, Sterile hypodermic needles for single use — Requirements and test methods ISO 8536‑13, Infusion equipment for medical use — Part 13: Graduated flow regulators for single use with fluid contact ISO 8536‑14, Infusion equipment for medical use — Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact ISO 14644‑1, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration ISO 15223‑1, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements ISO 80369‑7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications 3? Terms? and? definitions No terms and definitions are listed in this document. ISO and IEC maintain terminological databases for use in standardization at the following addresses: — ISO Online browsing platform: available at https://www.iso.org/obp — IEC Electropedia: available at http://www.electropedia.org/
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 A.2, the number of particles shall not exceed the contamination index limit. 7.2 Leakage The infusion set, when tested in accordance with A.3, shall show no signs of air leakage. 7.3 Tensile strength When tested as specified in A.4, the infusion set, excluding protective caps, shall withstand a static tensile force of not less than 15 N for 15 s.
7.5 Air‑inlet device The air‑inlet device can be an integral part of the infusion set (Figure 1) or a stand‑alone device (Figure 3). The air-inlet device shall be provided with an air filter to prevent the ingress of microorganisms into the container into which the device is to be inserted. When the air‑inlet device is in use the air admitted into the container shall not become entrained in the liquid‑entry of the closure‑piercing device. The air filter and the design of the air-inlet device shall be such that all air entering the rigid container passes through it, and such that the flow of fluid is not reduced by more than 20 % of that from a freely ventilated container when tested in accordance with A.5.2 and A.5.3. The closure‑piercing device or needle of the stand‑alone device shall be capable of piercing and penetrating the closure of a fluid container without pre-piercing. No coring should occur during this procedure. 7.6 Tubing The tubing, made of flexible material, shall be transparent or sufficiently translucent that the interface of air and water during the passage of air bubbles can be observed with normal or corrected 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. 7.7? Fluid? filter The infusion set shall be provided with a fluid filter. When tested in accordance with A.6, the retention of latex particles on the filter shall be not less than 80 %.