Latest Update: IEC 62133-2

In 2017, the 1^st Edition of the new IEC62133-2:2017 battery safety standard was released.

This updated safety standard does not affect already approved devices using RRC batteries complying with the 2^nd Edition of IEC62133:2012. As long as the certifications of these battery powered devices are in place and no approval update or change of the product is needed, the devices as well as the RRC batteries approved according to IEC62133:2012 can still be sold without limitations or a need for recertification.

New registrations or updates to existing battery-operated device approvals that have already begun must be completed by the relevant date of withdrawal if they use batteries that are certified according to IEC62133:2012. Otherwise a battery approved in accordance with IEC62133-2:2017 must be used.

The main changes between IEC62133:2012 and IEC62133-1:2017 / IEC62133-2:2017 (separating tests for Nickel and Lithium batteries into two documents) has no impact on the provided safety level.

Please find below a summary of the differences:

How to cope with the transition of the IEC62133-2:2017 standard in certification of a battery powered device for medical and industrial markets:

Medical devices

North America:

After discussions between RRC and the US Food and Drug Administration (FDA), the FDA decided to remove the transition period from IEC62133:2012 to IEC62133-2:2017. After 28^th December 2019 they recognize both editions concurrently until 2^nd Edition of the standard IEC62133-2:2017 is published, which is planned for 21^st March 2021 at the earliest. Therefore RRC customers can still use our current CB Report acc. IEC62133:2012 for their FDA registration.

Link: FDA Database for „Recognized consensus standards“:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/Search.cfm

Europe:

Some medical equipment will need to be changed or updated due to a re-classification of the new Medical Device Regulation or MDR (2017/745). Basically the transition date is the 26^th May 2020. Due to difficulties during the implementation of the new MDR, the Council of the European Union decided a corrigendum which implements other transition dates for some kind of medical devices. Every medical device manufacturer needs to clarify which is the appropriate transition date for its device. As long as no update for the medical device is indicated, the IEC62133:2012 approved RRC batteries can still be used.

For more information, please follow the link to the corrected MDR:

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20170505

India

The Bureau of Indian Standards (BIS) also adopted the new IEC62133-2:2017 in its national standard IS16046(Part2):2018. In contrast to the changeover in EU and North America this transition will also effect already approved products since the BIS Mark will change. After the transition date, importing non- conforming batteries to India will not be allowed. With corrigendum, BIS announced to postpone the date of withdrawal for the IS 16046:2015 to 30^th December 2020. Batteries imported before 30^th December 2020 can be sold and handled without limitation.

Link: https://www.crsbis.in/BIS/wtsnew.do

Industrial devices

North America:

All RRC standard batteries are UL recognized for Canada and US according UL2054 and UL60950/UL62368. UL2054 has superior safety levels than IEC62133-2:2017. This standards can be used in North America and are listed as appropriate standards from OSHA (US Occupational Safety and Health Administration).

Link: https://www.osha.gov/dts/otpca/nrtl/list_standards.html

Europe:

Ongoing or planned device approvals or updates using IEC 62133:2012  had to be finished prior to 14^th March 2020. After this date, only IEC62133-2:2017 will be accepted.

India:

Please see medical devices.

In case of further questions or discussions with your notified bodies, please contact RRC for detailed and battery specific information.