TAN Bead Maelstrom 9600 Manual Del Usuario página 8

1. Introduction
Safety and EMC Information
Safety Requirements
The medical device has passed the tests and conformed to the
⚫
standards of IEC 61010-1:2010 / AMD 1:2016 / COR 1:2019,
"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
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