Zeiss KSK 150 FC, Instructions For Use Manual

Page: 76 / 92

System Data KSK 150 FC
Version 7.1
Page 76 G-30-1158-en
Regulatory information
Approvals and requirements
Description Labeling
Electrical safety The medical device complies with the requirements
of
– IEC 60601-1:2005 + Cor. :2006 + Cor. :2007 +
A1:2012
– IEC 60601-1:2005 + A1:2012
– CAN/CSA-C22.2 No. 60601-1:2014
Protection class 1
EMC requirements According to IEC 60601-1-2:2007, modified the
medical device is classed as Class B (according to
CISPR 11).
Product classification The medical device is classed under Appendix IX of
the Medical Devices Directive 93/42/EEC as Class 1.
CE marking The device meets the essential requirements stipu-
lated in Annex I to Directive 93/42/EEC governing
medical devices.
The system is marked
RoHS compliance This product complies with the RoHS Directive
2011/65/EC.