IEC 61326-2-6: In vitro diagnostic (IVD) medical equipment – EMC requirements

The new edition of the standard that covers EMC testing of in-vitro (IVD) medical equipment – IEC 61326-2-6:2020 has been published recently. The latest version of IEC 61326-2-6 completely rewrites the EMC approach to IVD devices by drawing inspiration from the standard for medical devices – IEC 60601-1-2. The new edition borrows from it the terms such as “basic safety” and “essential performance”, meaning that the certification procedure will be quite familiar to anybody already involved in the medical equipment approval procedure.

The IVD standard takes a methodical approach. Even though there is no risk of direct harm to the patient, the hazard of the device returning wrong test results due to EMC disturbances, which can lead to a false diagnosis, is very real. Therefore, the story does not start in a laboratory, but rather at the office desk with the preparation of a risk management file and test plan to determine all potential risks of inadequate EMC protection and to define acceptance criteria for immunity tests. At this stage, possible environments for installation should be considered. Will the device be used in a professional environment (hospitals, laboratories, etc.) only, or is a home healthcare environment also a viable option?

The answers to these questions will help determine the required tests and test levels, with the home environment being stricter and harder to reach due to diverse electromagnetic phenomena.

When all the risks have been assessed, the test plan has been prepared and the installation environment has been determined, it is time to contact a reliable laboratory with the knowledge and equipment needed to perform the assessment procedure according to the standard. This is when SIQ comes into play, with its years of experience in testing of devices, including many medical appliances, and the knowledge to offer support in all stages of the approval procedure.

More information:
Mitja Rozman
E-mail: mitja.rozman@siq.si
Tel.: +386 1 4778 876