49
Regulatory Notices
Regulatory
approval type
Description
· IEC 61010-2-101 - “Safety Requirements for
Electrical Equipment for Measurement, Control,
and Laboratory Use; Part 2-101: Particular
Requirements for In Vitro Diagnostic (IVD)
Medical Equipment”.
CB Report A CB report to standards IEC 61010-1 2nd Edition and
Available upon IEC 61010-2-101 1st Edition has been prepared by
request Intertek Testing Services. A copy of the certificate is
available upon request.
EC Declaration of This product meets the intent of Directive 98/79/EC
Conformity - IVD for In Vitro Diagnostic Medical Devices. Consult the
Declaration of Conformance certificate shipped with
the product (if required) for the latest update.
U.S. FDA Listing The osmometer, along with the calibrators and controls
manufactured by Advanced Instruments, are listed with
a U.S. Department of Health and Human Services,
Food and Drug Administration, as:
Osmometer Class 1
Calibrators Class 2
Controls Class 1
Health Canada The osmometer, along with the calibrators and controls
License manufactured by Advanced Instruments, are licensed
with Health Canada, Therapeutic Products Directorate,
Medical Devices Bureau, as:
Osmometer Class 2
Calibrators Class 2
Controls Class 2
FCC - Part 15, This device complies with Part 15 of the FCC Rules.
Subpart B, Class A Operation is subject to the following two conditions:
(1) this device may not cause harmful interference, and
(2) this device must accept any interference received,
including interference that may cause undesired opera-
tion.
(continued)
To Next Page
Loading...
Need help?
General
