Advanced Instruments 3250 - Page 95

95
Advanced
™
Osmometer Model 3250 User’s Guide
Regulatory approval type Description
CE Declaration of
Conformity - Low
Voltage
This product meets the intent of Directive
2014/35/EU, the Low Voltage Directive.
Compliance was demonstrated using the
following standards as listed in the Official
Journal of the European Communities: Consult
the Declaration of Conformance certificate
shipped with the product (if required) for the
latest update.
• EN 61010-1, “Safety Requirements for
Electrical Equipment for Measurement,Control
and Laboratory Use - Part 1: General
Requirements”.
• EN 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
CB Certificate
A CB report and certificate have been issued
for this product. A copy of this certificate is
available upon request.
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 1
Controls Class 1
Health Canada License
The osmometer, along with the calibrators and
controls 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