DrillSaw Highspeed 200™ User’s Guide
DFU-0225-2 Rev. 0 Page 20 of 58
3.5 Safety, EMC, and Regulatory Requirements
Parameter Parameter Value
System Classification
IEC 60601-1 Class II
(protection against electric shock)
FDA class Class I exempt
EU class Class IIa
Health Canada Class Class 2
Safety Certifications
Domestic Certification ANSI/AAMI ES60601-1
(2005+C2+A2)
Canadian Certification CSA C22.2 No 60601.1
(2008)
EU Certification IEC 60601-1:2005+A1:2012
EMC Certifications EMC Certification EN 60601-1-2 :2015-09
Safety Certification
Marking
UL
CE Classification
MDD 93/42/EEC
Annex IX Rule 9 Class IIa
Refer to section 14 for further details on EMC certification.
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