DIN EN ISO 8536-4 – Infusion equipment for medical use – Part 4: Infusion sets for single use, gravity feed

This standard 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. Further it provides guidance on specifications relation to the quality and performance of materials used in infusion sets.

Test methods included are:

• Test method for particulate contamination
• Test for leakage
• Test for tensile strength
• Determination of flow rate
• Test for efficiency of the fluid filter
• Test of the injection site