Roche Diagnostics
Addendum version 1.0 · 5
cobas c 111 analyzer Revisions to cobas c 111 instrument publications
Revision 1: Addition of RoHS directive and update of CE compliance
Revisions to cobas c 111 instrument publications
Revision 1: Addition of RoHS directive and update of CE compliance
Instrument approvals The cobas c 111 instrument meets the requirements laid down in:
Directive 98/79/EC of the European Parliament and of the Council of 27 October
1998 on in vitro diagnostic medical devices.
Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011
on the restriction of the use of certain hazardous substances in electrical and
electronic equipment.
Compliance is provided by means of the Declaration of Conformity.
The following marks demonstrate compliance:
Publication title Publication version Software version Publication date Revised topic title
Operator’s Manual 4.1 4.1 October 2013 Publication information
Table 2 Revision location
For in vitro diagnostic use.
Complies with the provisions of the applicable EU directives.
Issued by Underwriters Laboratories, Inc. (UL) for Canada and
theUS.
CUS
®
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