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 pdf free download here.
BS EN ISO 8536-4:2020 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
ISO 3696, Water for analytical laboratory use – Specification and test methods;
ISO 7864, Sterile hypodermic needles for single use – Requiremments and test methods;
ISO 8536-13, infusion equipment for medical use – Part 13: Graduated flow regulators for single use with
id contact.
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 requirem
7.1 Particulate contamination
The infusion set and stand-alone air-inlet device shall be manufactured under conditions that minimize
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 d, the infusion set, excluding protective caps, shall withstand a static
tensile force of not less than 15N for 15s.