B E Y O N D M O T I O N
Active Wand v2
Page 7
EU Declaration of Conformity - Active Wand
Declaration of Conformity
Medical Devices Directive 93/42/EEC as amended by
EU Council Directive 2007/47/EC of 5
th
September 2007 and
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 active calibration wand as part of a Vicon Gait Analysis System manufactured by VICON
MOTION SYSTEMS LIMITED in that the Quality Management System has been approved by BSI Assurance
UK Ltd for the manufacture and support of the aforementioned CLASS 1 Medical device.
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:
EN60601-1-2:2007
General Requirements for Safety to:
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
Thomas Shannon TD PhD FIE (Aust) CPEng (Biomed.)
Director of Compliance
16
th
March 2021
Date of Expiration
Validity of the MD727611 Certificate.
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, ionising radiation, sterile, or life- or safety-critical environments.
