...

Designed and manufactured in accordance with IEC 60601-1 Ed. 3.0 (2005) + Amd. 1 (2012) + Amd. 2 (2020) and its side standards e suas normas colaterais IEC 60601-1-2 Ed. 4.0 (2014) + Amd. 1 (2020), ABNT NBR IEC 60601-1-6:20192020, ABNT NBR IEC 60601-1-9 ED. 1.1 B:2013 and :2014 e IEC 60601-1-11 Ed. 2.0 (2015) + Amd. 1 (2020).

...

The modules BcSs-PICNIW-1000 and BcSs-PICNIW-1000 are registered with Anvisa and 2000 have passed biocompatibility tests in accordance with standards NBR IEC 60601-1, ISO 10993-10:2010, EN ISO 10993-10:2013 and e ISO 10993-5:2009..

3.4.2 classification

Equipment type BF. Continuous operation. Internal and external power through batteries only. Risk Class III, in accordance with CRF Title 21. It accompanies a protection class II power adapter and charger.

...