IEC 62368-1 Ed. 4: Key Updates & Implications for Manufacturers

Last updated: 19 June 2023

On 30 December 2022, the final draft for the international standard (FDIS) for IEC 62368-1 ed.4 was sent for hearing to ensure the standard’s final wording is correct. The deadline to provide feedback is 10 February 2023, and the standard was published on 26 May 2023.

The FDIS is also submitted to CENELEC, the European Committee for Electrotechnical Standardization, for parallel voting.
CENELEC, however, still has not indicated the time for publication of the European standard (EN IEC 62368-1:2023). 

Standards for CE marking
EN 62368-1:2014 (ed. 2) is the only version in the Official Journal and will be withdrawn in July 2024 (DOW for EN IEC 62368-1 ed.3 set to 6 July 2024).
It is expected that ed.4 can be cited in Official Journal.
The recommendation is, therefore, to update ed.4 as soon as it is accepted for the Official Journal.

For manufacturers who choose to test and certify to ed.3 instead of ed.4  next year, an extensive risk analysis will need to be attached as part of their CE documentation package.

Please, also note that components and parts can no longer be documented to IEC 60065 / IEC 60950-1in ed.4 (ref. Clause 4.1.1 in ed.2 and ed.3). Re-testing and new documentation may be required for manufacturers who currently have products with components and parts covered by these standards.

If you are unsure if this applies to your product, please do not hesitate to contact us so we can help you with the assessment.