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NUCLEUS 7 SOUND PROCESSOR USER GUIDE
O
THER
INFORMA
T
ION
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 2016.
The Nucleus 7 Sound Processor also fulfils the essential
requirements listed in the EC directive 1999/5/EC on Radio
and Terminal Telecommunication Equipment as per the
conformity assessment procedure in Annex IV.
DRAFT ONLY FOR CLINICAL TESTING
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