Regulatory Information - Zeiss S7 / OPMI VISU 160 Instructions For Use Manual

S7 / OPMI VISU 160

Regulatory information

Version 6.0
G-30-1528-en
S7 / OPMI VISU 160
Electrical safety
Electromagnetic com-
patibility
Classification
CE marking
RoHS compliance
The medical device complies with the requirements
according to
– IEC 60601-1:2005,
– IEC 601-1:1988+A1:1991+A2:1995,
– CAN/CSA-C22.2 No. 601.1-M90.
Classification by level of protection against elec-
trical shock: Protection class 1
Protection type (according to IEC 60529): IP X0
According to IEC 60601-1-2:2007 the medical de-
vice 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 medical device complies with the essential re-
quirements stipulated in Appendix I of the Medical
Device Directive 93/42/EEC.
In line with Appendix XII of the Medical Device Di-
rective 93/42/EEC the medical device is labeled
with
.
The product is RoHS compliant in accordance with
Directive 2011/65/EU.
System Data
Page 183