What is ISO 8536-4 about?
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.
Who is ISO 8536-4 for?
ISO 8536-4 on infusion sets for single use is useful for:
- Manufacturers of infusion medical equipment
- Test centers for infusion medical equipment
- Hospitals
- Regulatory authorities
Why should you use ISO 8536-4?
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.
What’s changed since the last update?
BS EN ISO 8536-4:2020 supersedes ISO 8536-4:2010, which has been withdrawn.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.