11 REGULATORY INFORMATION
11.1 Classification EU
In accordance with MDD 93/42/EEC: Class IIa medical device
EN60601-1: Internally powered equipment
11.1.1 Declaration of Conformity
We herewith declare under our sole responsibility that the product listed below is in conformity with the
provisions of the Council Directive 93/42/EEC of 14 June 1993 (and the Finnish national laws 1505/94 and
1506/94) concerning medical devices. When used with external evaluation software this declaration of
conformity is valid for the Faros hardware.
Trade Name: Faros Product Family
Model(s): Faros 180
Faros 360
MDD Classification: Class IIa
Following standards were used to meet requirements:
• IEC 60601-1:2005+AMD1:2012+AMD2:2020, Medical Electrical Equipment - Part 1 General
Requirements for Basic Safety and Essential Performance.
• IEC 60601-1-2: 2014, Medical Electrical Equipment - Part 1-2: General Requirements for Basic
Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -
Requirements and Tests.
• IEC 60601-2-47:2012, Particular requirements for the basic safety and essential performance of
ambulatory electrocardiographic systems.
• IEC 60601-1-11:2015+AMD1:2020, Medical electrical equipment -- Part 1-11: General requirements
for basic safety and essential performance -- Collateral standard: Requirements for medical electri-
cal equipment and medical electrical systems used in the home healthcare environment.
• IEC 62366-1:2015+AMD1:2020, Medical devices -- Application of usability engineering to medical
devices.
• IEC 62304:2006, Medical device software -- Software lifecycle processes.
• According to the manufacturer of the Bluetooth modules: The Bluetooth modules meet the
requirements of the EMC Directive 89/336/EEC as amended by Directives 92/31/EEC and
93/68/EEC within CE marking requirement.
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