ISO 8536 discusses infusion equipment for medical use. ISO 8536-4 outlines requirements for single-use, gravity feed infusion sets for medical use to ensure their compatibility with containers for infusion solutions and intravenous equipment.
The secondary aims of ISO 8536-4 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.
ISO 8536-4 on infusion sets for single use is useful for:
The purpose of the infusion set is to deliver insulin under the skin, fulfilling a similar function like an intravenous line. It is a complete tubing system to connect an insulin pump user, and such includes a subcutaneous cannula. Adhesive mount, quick-disconnect, and a pump cartridge connector.
ISO 8536-4 guideline provides general requirements on materials, physical requirements, chemical requirements, biological requirements, labelling, and packaging for gravity feed single-use infusion set for medical use. This helps to improve the quality and ensure their compatibility of gravity feed Infusion sets for single use.
BS EN ISO 8536-4:2020 supersedes ISO 8536-4:2010, which has been withdrawn. BS EN ISO 8536-4:2020 has some technical changes with respect to ISO 8536-4:2010.
EN ISO 8536-4:2020
ISO 8536-4:2019