User's Manual

Table Of Contents
B5 Directives and Standards
The Tobii Dynavox I-Series complies with the following directives:
Medical Device Directive 93/42/EEC
Low voltage Directive 2014/35/EU
Electromagnetic Compatibility (EMC) Directive 2014/30/EU
Radio Equipment Directive (RED) 2014/53/EU
RoHS2 Directive 2011/65/EU
WEEE Directive 2012/19/EU
Reach Directive 2006/121/EC, 1907/2006/EC Annex 17
ISO 14971:2007
ISO 13485:2016
The device has been tested to comply with IEC/EN 60601-1 Ed 3.1, IEC/EN 60950-1, ISO 14971:2007 and other relevant
standards for the intended markets.
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Appendix B Compliance Information
Tobii Dynavox I-Series User’s manual v. - en-US