Regulatory Information - Zeiss KSK 150 FC Instructions For Use Manual

System Data

Regulatory information

Page 76
Approvals and requirements
Description
Electrical safety
EMC requirements
Product classification
CE marking
RoHS compliance
Labeling
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
According to IEC 60601-1-2:2007, modified the
medical device is classed as Class B (according to
CISPR 11).
The medical device is classed under Appendix IX of
the Medical Devices Directive 93/42/EEC as Class 1.
The device meets the essential requirements stipu-
lated in Annex I to Directive 93/42/EEC governing
medical devices.
The system is marked
This product complies with the RoHS Directive
2011/65/EC.
KSK 150 FC
Version 7.1
G-30-1158-en