DrillSaw Sports 400™ System
User’s Guide
DFU-0253-4r0_fmt_en-US
Page 15 of
46
Safety, EMC, and Regulatory Requirements
Table 9
Safety, EMC, and Regulatory Requirements
Parameter
Parameter Value
System Classification
IEC 60601-1
Class I
(protection against electric
shock)
FDA class
Class I
EU class
Class IIa
Health Canada Class
Class II
Safety Certifications
Domestic Certification
ANSI/AAMI ES60601-1
(2005+C2+A2)
Canadian Certification
CSA C22.2 No 60601.1
(2008)
EU Certification
EN/IEC 60601-1 3
rd
ed. +
Amendment 1
EMC Certifications
EMC Certification
EN 60601-1-2 4
th
Safety Certification Marking
UL
CE Classification
MDD 93/42/EEC
Annex IX Rule 9
Class IIa
For all other accessories refer to accompanying DFUs for more information. Refer to Section
11.0 Electromagnetic Emissions for further details on EMC certification.
