Declaration of Conformity
Medical Devices Directive 93/42/EEC as amended by EU Council Directive
2007/47/EC of 5th September 2007
Electromagnetic Compatibility to EMC Directive 2014/30/EU.
Electrical Safety to Low Voltage Directive 2014/35/EU.
We, Vicon Motion Systems Limited
Unit 6, Oxford Industrial Park
Mead Road, Yarnton, Oxford, OX5 1QU
declare that the VICON MX T-Series System manufactured by VICON MOTION SYSTEMS LIMITED meets ANNEX V and VII, Section 5 of the Medical Devices Directive 93/42/EEC as amended by Directive 2007/47/EC in that the Quality Management System has been approved by Dare!! Services B.V., a notified body of the European Union (Reg No. 1912) for the manufacture and support of the aforementioned CLASS 1(m) Medical device. Product configurations and software options (Vicon MX T-Series) overleaf detail the product configurations and software options that conform to the metrological requirements of the Directive.
This declaration of conformity is issued under the sole responsibility of the manufacturer.
VICON MOTION SYSTEMS LIMITED has tested and demonstrated that all products of its own manufacture meet 2014/30/EU:
Electromagnetic Compatibility to:
General Requirements for Safety to:
T-Series Cameras (including Bonita and Bonita 2), Active Wand and Giganet
EN60601-1:2006 + A12:2014
Software Development, Conformity and Support
EN ISO 13485:2016
EN ISO 14971:2019
BS EN 62304:2006 + A1:2015, IEC 62304:2006/A1:2015
T.M.L. Shannon, TD, FIE (Aust), CPEng (Biomedical)
Director of Regulatory Compliance
16th March 2021
Date of Expiration 27th May 2024 (Article 120, EU 2017/745), subject to meeting the continued surveillance obligations, Section 4, Annex V. Certificate Number 20M00097CRT04 8th September, 2020.
Not for use in an operating theatre, anaesthetic gas environment, or oxygen-rich environments. Not for use where there is a risk of compromising the essential performance of medical electrical equipment. Not suitable for use in high magnetic flux, ionizing radiation, sterile, or life- or safety-critical environments.
Note: The overall installed system classification is defined by the highest risk device connected which may include the connection of approved third-party equipment such as electromyography apparatus by clients.