Product Testing and Certification

IEC 62368-1 4th Ed: Safety standard updates

19. December 2022

After the positive vote on CDV and implementing corrections of comments identified by National Committees, TC108 sent a draft FDIS version to the IEC Secretariat for a final review before putting the document in circulation. It is expected that FDIS will be available by the end of December 2022 or by mid of January 2023. It is therefore still possible to get the new IEC standard IEC 62368-1 4th Ed by the end of Q2 2023.

The situation in the EU is much more complicated. A HAS consultant has not finalized the assessment of the CDV version yet. If the assessment is positive, then we can expect to have cited standards in the OJEU around the end of 2023. If the assessment is negative, this might impact the date of the citation, since TC108X will have to work on the HAS consultant’s comments and prepare amendment A22. To get more precise information, we need to wait for the conclusions of the HAS consultant’s assessment. Unfortunately, no date is available yet for when this will happen.

More information:
Boštjan Glavič
Tel.: +386 1 4778 265

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