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.