Cortrium C3+ - Regulatory Information

C3+ IFU - 0723 01140 (70048) UK Page 16 of 18
Single use / reusable
Reusable/Rechargeable Monitor
Recording standard
Holter
Recording format
Continuous
Intended placement
Midsternal line
Recording period
Up to 7 days on a single charge
6.2 Regulatory information
The C3+ is a class IIa medical device according to 93/42/EEC. The C3+ complies with the following
product standards:
DS/EN 60601-1-1
Safety Requirements for Medical Electrical Systems
DS/EN 60601-1-2
Electromagnetic Disturbances
DS/EN 60601-1-6
Medical Electrical Usability
DS/EN 60601-1-11
Home Healthcare Environment
DS/EN 60601-2-47
Particular requirements for the basic safety and essential
performance of ambulatory electrocardiographic systems
DS/EN 62366-1
Application of usability engineering to medical devices
DS/EN ISO 10993-1
Biological evaluation of medical devices
DS/EN ISO 15223-1
Symbols to be used with medical device labels, labelling and
information supplied
DS/EN 1041
Information supplied by the manufacturer of medical devices
DS/EN 62304
Medical device software – software life cycle processes
DS/EN ISO 14971
Application of risk management to medical devices
EN 301 489-17 V3.1.1
Electromagnetic Compatibility (EMC) standard for radio
equipment and services; Part 17
EN 300 328 V2.1.1
Wideband transmission systems; Data transmission equipment
operating in the 2,4 GHz ISM band