Arc-Family Arc4Sports Manuel de l'utilisateur - Page 11
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0088
EC Declaration of Conformity
The Arc4Sports Microcurrent Therapy System complies with the requirements of the
Medical Devices Directive 93/42/EEC as amended. Arc4Sports is considered to be a
Class 11a Medical device. Compliance has been demonstrated with reference to the
following harmonised standards
•
EN 60601-1:2006+A12:2014
•
EN 60601-2-10:2015.
•
EN 60601-1-2: 2007+AC:2010
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2016/10 V.1