OsmoPRO® Multi-Sample Micro-Osmometer User’s Guide
80
Regulatory Approval
Description
EC 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 - 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".
EC Declaration of Conformity
- IVD
This product meets the intent of Directive 98/79/EC for In Vitro
Diagnostic Medical Devices. Consult the Declaration of
Conformance certificate shipped with the product (if required) for
the latest update.
FCC - Part 15,
Subpart B, Class B
This device complies with Part 15 of the FCC Rules. Operation is
subject to the following two conditions:
This device may not cause harmful interference, and this device
must accept any interference received, including interference
which may cause undesired operation.
Canadian
This Class B digital apparatus complies with Canadian ICES-003.
ICES-003
Cet appareil numérique de la classe B est conforme à la norme
NMB-003 du Canada.
Japan VCCI
This Class B digital apparatus complies with VCCI technical
requirement V-3.
EC Declaration of Conformity
- WEEE
This product meets the intent of Directive 2012/19/EU for Waste
Electrical and Electronic Equipment (WEEE). Consult the
Declaration of Conformance certificate shipped with the product
(if required) for the latest update.
EC Declaration of Conformity
- RoHS
This product meets the intent of Directive 2011/65/EU for
“Restriction of the Use of Certain Hazardous Substances in
Electrical and Electronic Equipment”
CB Certificate
A copy of the certificate is available upon request.
U.S. FDA Listing
The osmometer, along with the calibrators and controls
manufactured by Advanced Instruments, are listed with the U.S.
Department of Health and Human Services, Food and Drug
Administration, as: Osmometer Class 1 Calibrators Class 2
Controls Class 1.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
