Appendix D Regulatory notices
47
Osmo1™ Single-Sample Micro-Osmometer Service Guide
Regulatory
approval type Description
EU Declaration of
Conformity: Radio
Equipment Directive
(RED)
This product meets the intent of Directive 2014/53/EU, the Radio Equipment Directive. Compliance was
demonstrated using the following standards as listed in the Ocial Journal of the European Communities:
Safety:
• 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”
Emissions & Immunity: Class A Digital Device:
• EN 61326-1, “Electrical Equipment for Measurement, Control, and Laboratory Use, Part 1: General
Requirements”
• EN 61326-2-6, “Electrical Equipment for Measurement, Control, and Laboratory Use, Part 2-6: Particular
Requirements IVD”
• ETSI EN 301 489-1, “Electromagnetic Compatibility Standard for Radio Equipment & Services, Part 1: Common
Technical Requirements”
• ETSI EN 301 489-3, “Electromagnetic Compatibility and Radio Spectrum Matters, Standard for Radio
Equipment & Services, Part 3: Specific Conditions for Short-Range Devices (SRD)”
• ETSI EN 300 330, “Short Range Devices (SRD); Essential Requirements of article 3.2 of Directive”
Consult the Declaration of Conformity shipped with the product (if required) for the latest update.
EU Declaration of
Conformity - IVD
This product meets the intent of Directive 98/79/EC for In Vitro Diagnostic Medical Devices. Consult the Declaration
of Conformity shipped with the product (if required) for the latest update.
FCC: Part 15, Subpart
B & C, Class A
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: 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.
Japan VCCI This Class A digital apparatus complies with VCCI technical requirement V-3.
RFID Statement This product contains an RF Module:
FCC ID: E36-0005
IC: 20739-BISM410
Frequency: 13.56MHz
Tx Power: <68 dBuv @ 3.0 m
EU 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 Conformity shipped with the product (if required) for the latest update.
EU 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.
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