13
The Advanced
®
Osmometer Model 3320 Service Manual
Regulatory
approval type Description
EC Declaration of This product meets the intent of
Conformity - IVD 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.
CB Report A CB report to standard IEC
Available upon 61010-1 and IEC 61010-2-101 has
request been prepared by Intertek Testing
Services. A certificate is available
upon request.
FCC - Part 15 This device complies with Part 15
Subpart B, Class A of the FCC Rules. Operation is
subject to the following two condi-
tions: (1) this device may not
cause harmful interference, and (2)
this device must accept any inter-
ference received, including inter-
ference that may cause undesired
operation.
Canadian ICES-003 This Class A digital apparatus
complies with Canadian ICES-003.
Cet appareil
numérique
de la
classe A est conforme
à
la norme
NMB-003 du Canada.
U.S. FDA Listing The osmometer, along with the
calibrators and controls manufac-
tured 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
Regulatory
approval type Description
Health Canada The osmometer, along with the
License calibrators and controls manufac-
tured by Advanced Instruments,
are licensed with Health Canada,
Therapeutic Products Directorate,
Medical Devices Bureau, as:
Osmometer Class 2
Calibrators Class 2
Controls Class 2
EC Declaration of This product meets the intent of
Conformity - WEEE Directive 2002/96/EC as amended
by 2003/108/EC for Waste
Electrical and Electronic
Equipment (WEEE). Consult the
Declaration of Conformance cer-
tificate shipped with the product
(if required) for the latest update.
RoHS This product meets the intent of
Directive 2002/95/EC for the
Restriction of Use of Certain
Hazardous Substances. This prod-
uct is exempt under the terms of
Article 2, paragraph 1 due to its
listing in Category 8 and/or 9 of
Directive 2002/96/EC.
To Next Page
Loading...
Need help?
General