Thermo Scientific Sensititre AIM Instrucciones De Uso página 8

Safety Standards
Safety standards
IEC 61010-1
IEC 61010-2-101
EMC Standards and Regulations
EMC standards
IEC 61326-2-6
IEC 60601-1-2:2014
Immunity to proximity
fields
FCC Part 15.107 and
Part 15.109
ICES-001
Sensititre AIM™ Instructions for Use
Reference Description
Safety requirements for electrical equipment for measurement,
control, and laboratory use – Part 1: General requirements.
Instrument complies with electrical safety standard
requirements of
EN 61010-1:2010+A1:2019
IEC 61010-1:2010 +A1:2016
UL 61010-1, 3rd edition, 2019
CAN/CSA C22.2 No. 61010-1-12 (R2017)
Safety requirements for electrical equipment for measurement,
control and laboratory use – Part 2-101: Particular
requirements for in vitro diagnostic (IVD) medical equipment.
Instrument complies with electrical safety standards
requirement of IEC 61010-2-101:2018.
Reference Description
Electrical Equipment for Measurement, Control and Laboratory
Use – EMC Requirements – Part 2-6: Particular Requirements
- In Vitro Diagnostic (IVD) Medical Equipment. Instrument
complies with the emission and immunity requirements of
EN IEC 61326-2-6:2021
IEC 61326-2-6:2020
Medical electrical equipment - Part 1-2: General requirements
for basic safety and essential performance - Collateral
Standard: Electromagnetic disturbances - Requirements and
tests
IEC 60601-1-2:2014
Table 9
Federal Communications Commission (FCC)
US Code of Federal Regulations, Title 47, Part 15 (47 CFR 15)
Radio Frequency Devices
Canadian Interference-Causing Equipment Standard (ICES):
Industrial, Scientific and Medical (ISM) Equipment
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