Jabra Enhance Select 50R User Manual page 53

Non-clinical testing
The devices covered within this user guide have undergone tests for the relevant non-clinical performance
testing and biological endpoints in accordance with standards identified below:
•
Electrical safety testing is performed according to IEC 60601-1:2005 + A1:2012+A2:2020, IEC 60601-2-
66:2019, IEC 60601-1-11 Edition 2.0 2015-1, IEC 62133-2 Edition 1.0 2017- 02 and IEC 62368-
1:2018/COR1:2020.
•
Electromagnetic compatibility (EMC) testing is performed according to IEC 62479:2010, ANSI IEEE
C63.19-2019 and IEC 60601-1-2:2014+A1:2020.
•
Radio and Telecommunication testing is performed to be in compliance with applicable parts of the FCC
rules in title 47 of the CFR.
•
Electroacoustic testing is performed according to ANSI/ASA S3.22-2014 and ANSI/CTA 2051:2017
•
Usability Engineering was performed in compliance with IEC 62366-1:2015
The devices covered in this user guide passed all tests for the relevant non-clinical performance testing and
biological endpoints, namely cytotoxicity (ISO 10993-05:2009), sensitization, and intracutaneous reactivity
(ISO 10993-10:2010).
Similarly, usability testing and software verification and validation demonstrated mitigation of risks to an
acceptable level as well as reasonable assurance of safe and effective device performance.
Clinical data
The devices have been evaluated clinically through equivalence, and the devices have been compared to
equivalent devices and similar devices on the market with similar intended purpose, e.g., to compensate for
hearing impairment by amplifying and transmitting sound to the ear.
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