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NUCLEUS® 7 HYBRID MODE PROFESSIONALS GUIDE
Certification and applied standards
The Nucleus 7 Sound Processor fulfils the essential requirements listed in Annex 1 of the
EC directive 90/385/EEC on Active Implantable Medical Devices as per the conformity
assessment procedure in Annex 2.
The year in which authorisation to affix the CE mark was granted was 2017.
Equipment classification
The sound processor is internally powered equipment Type B applied part as described in
the international standard IEC 60601-1:2005/A1:2012, Medical Electrical Equipment –
Part 1: General Requirements for Basic Safety and Essential Performance.
Legal statement
The statements made in this guide are believed to be true and correct as of the date of
publication. However, specifications are subject to change without notice.
© Cochlear Limited 2017
Summary of Contents for Nucleus 7 Hybrid Mode
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