The IEC 62133 is an important safety standard for Li-Ion-batteries used in medical-devices, IT-devices, tools, laboratory-, household- and consumer goods. In February 2017 the International Electrotechnical Commission (IEC) published an updated version of the safety standard which will replace IEC62133:2012 by March 14th 2020.
The updated safety standard will be split in two new safety standards.
- IEC62133-1:2017 [Part 1: Nickel Systems]
- IEC62133-2:2017 [Part 2: Li-Ion Systems]
IEC62133-2:2017 includes new recommendations concerning the assembly of cells in battery packs, an updated index, mechanical vibration and shock tests similar to UN38.3 transport test.
IEC62133-2:2017 has already been implemented at RRC. The up-to-date standard battery packs are RRC2040-2, RRC2054 and RRC2057 have been successfully certified to IEC62133-2:2017 and will be available within the next few weeks. The certification will also be integrated in all other RRC Power PAQs shortly. All device submissions which have been issued or changed after March 14, 2020, need a report/certification to the new IEC62133-2:2017.
Additionally, units with IEC62133:2012 have to be updated after a construction or registration change and can be used up to this point without any restriction.
One special case is the FDA admission for medical devices in the US. The transition period was until December 28, 2019, but RRC has been informed by the FDA (U.S. Food & Drug Administration) that the transition period will be extended. An official confirmation will follow on the FDA’s website.
It does not matter in which development phase you are in or industry you serve, we are here to help. We can provide assistance with regulatory authorities, answer questions, provide certificates and reports, samples, etc. Our application support team is here to help you.