Is REVIAN safe? What safety testing has REVIAN undergone?
Yes, REVIAN is very safe. REVIAN was cleared by the United States Food and Drug Administration under 510(k) #K173729 in 2018 according to the federal standards for safety and electromagnetic compatibility.
REVIAN was tested to IEC 60601-1 and 60601-1-2 to confirm the device’s electrical safety and electromagnetic compatibility and conformance with ANSI/AAMI HA60601-1-11:2015, IEC 60601-2-57 (Edition 1.0), and IEC 62471 (Edition 1.0).
Biocompatibility testing of the Cap per ISO 10993-1 confirmed no effects of the applied parts were noted for cytotoxicity, skin irritation or skin sensitization.
Performance verification and validation testing demonstrates REVIAN meets user needs and design inputs and met requirements for its intended use.
Human factors evaluation of REVIAN was tested following ANSI/AAMI/IEC 62366-1 and 60601-1-6 standards. The study protocol was designed to evaluate representative users of the device under expected use conditions during simulated and actual use of the device. The Human Factors Engineering and Usability Engineering process involved several methodologies, including observational user research, formative and summative user testing.
REVIAN has been independently evaluated and confirmed to conform to the following safety standards:
ANSI/AAMI/ISO 10993-1 2009/(R)2013 – Biological Evaluation of Medical Devices
ANSI/AAMI ES60601-1:2005/(R)2012 – Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
ANSI/AAMI/IEC 60601-1-2:2014 – Medical Electrical Equipment – General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests.
IEC 60601-2-57 – Medical Electrical Equipment – Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, and cosmetic/aesthetic use.
IEC 62471 Ed. 1.0 – Photobiological safety of lamps and lamp systems.
IEC 62133-2 Ed. 1.0 – Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications – Part 2: lithium systems