Guidelines, regulations and standards
This device is classified as a wellness device and meets UL/CE standards.
The EndoLight® is compliant according to:
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IEC EN 60335 1:2012 + A11:2014 + A13:2017 + A1:2019 + A14:2019 + A2:2019 + A15:2021 –
EN 62233:2008 Safety of household and similar electrical appliances
It complies with all European regulations on electromagnetic compatibility (EMC):
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Emission EN 61000-6-3:2007 + A1:2011
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Immunity EN 61000-6-1:2007
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EN 55032:2015 + A11:2020 FCC CFR 47 part 15 subpart B ICES-003:2016 updated April 2019
The EndoLight® is RoHS 3 compliant and contains no toxic chemicals.
Graphic 1: CE Declaration of Conformity
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