Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
The text of this standard is sold by IEC and is not reproduced here. This page gives the code, edition, scope and what each market says about it.
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
| Market | Status | Edition accepted | National code | Details |
|---|---|---|---|---|
| United States | Recognized | Edition 4 | - | Complete recognition. Voluntary: a declaration of conformity to a recognized standard can be used in a submission.. An earlier FDA EMC guidance from June 2022 said the 2020 edition was partially recognized. The ASCA program page of July 2025 says full recognition. The database sheet was not checked. |
| Japan | Referenced | IEC 61326-2-6:2020 | JIS C 61326-2-6:2023 |
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: YY 9706.102-2021, IEC 60601-1-2, ISO 14117, JIS T 0601-1-2, IEC 61326-1. See all standards.
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.
| Named as an example of an appropriate EMC standard for laboratory test equipment, used in place of the JIS EMC collateral standard. |
| Canada | Recognized | Latest version (the list gives no edition or year) | - | When a new version is published, both the newest and the previous version stay recognized for 3 years from the date the newest version was published.. Voluntary: a manufacturer meets the standard, meets an equivalent or better standard, or gives other evidence of safety or effectiveness. A Declaration of Conformity is submitted when a recognized standard is used. |