Safety and EMC Information
Safety Requirements
The medical device has passed the tests and conformed to the
standards of IEC 61010-1:2010, “Safety requirements for electrical
equipment for measurement, control, and laboratory use - Part 1:
General requirements”.
The medical device has passed the tests and conformed to the
standards of IEC 61010-2-101:2018, “Safety requirements for
electrical equipment for measurement, control and laboratory use
- Part 2-101: Particular requirements for in vitro diagnostic (IVD)
medical equipment”.
EMC Requirements
The medical device has passed the tests and conformed to the
standards of IEC 61326-1:2012 & IEC 61326-2-6:2012, “Electrical
equipment for measurement, control and laboratory use - EMC
requirements - Part 2-6: Particular requirements - In vitro
diagnostic (IVD) medical equipment”.
The medical device has passed the tests and conformed to
following standards:
EN 61326-1:2013
EN 61326-2-6:2013
9
1. Introduction
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