IEC 61326-2-6 IVD EMC Testing Laboratories
IEC 61326-2-6 is the part of the IEC 61326 family setting particular EMC requirements for in vitro diagnostic medical equipment, applied together with the general document in the same family.
When is it used?
- IVD analysers, readers and point-of-care instruments
- Adding connectivity, sample handling automation or new detection modules
- Investigating measurement disturbance traced to the electromagnetic environment
Sample considerations
- Define the analytical performance that must be maintained during immunity exposure, and how it will be monitored.
- Provide controls, quality control material or simulators so the instrument runs a representative assay during testing.
- Confirm whether any part of your product also falls under the IEC 60601 family.