0123 Declaration of Conformity
Medical Devices Directive 93/42/EEC as amended by
EU Council Directive 2007/47/EC of 5th September 2007 and
Electromagnetic Compatibility to EMC Directive 2014/30/EU.
We, Vicon Motion Systems Limited
Unit 6, Oxford Industrial Park
Mead Road, Yarnton, Oxford, OX5 1QU
Declare that the VICON LOCK LAB manufactured by VICON MOTION SYSTEMS LIMITED meets ANNEX V and VII Section 5 of the Medical Devices Directive 93/42/EEC in that the Quality Management System has been approved by TÜV SÜD Product Service GmbH Zertifizierstellen, a notified body of the European Union (Reg No. 0123) for the manufacture and support of the aforementioned CLASS 1(m) Medical device. Product configurations and software options (Vicon Lock Lab) 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:
EN60601-1:2006 + A1:2013
Thomas Shannon TD PhD FIE (Aust) CPEng (Biomed.)
Director of Compliance
11 September 2019
Not for use in an operating theatre, anaesthetic gas 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.