Infusion & Transfusion - Related International Standards

The following non-harmonised international standards are related to Infusion & Transfusion for EU MDR compliance reference.

Standard	Title	Status	GSPRs	Link
ISO 8536-4:2019	Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed	active	1, 3, 5, 10, 11	Link
ISO 8536-8:2015	Infusion equipment for medical use - Part 8: Infusion equipment for use with pressure infusion apparatus	active	1, 3, 5, 10, 11	Link
ISO 1135-4:2025	Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed	active	1, 3, 5, 10, 11	Link
IEC 60601-2-24:2012	Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers	active	1, 3, 5, 9, 14	Link
ISO 28620:2020	Medical devices - Non-electrically driven portable infusion devices	active	1, 3, 5	Link