neuroConn DC-Stimulator, User Manual

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Chapter 2 - Safety
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Safety 2
The DC- STIMULATOR has been certified as an active medical device class IIa.
CAUTION FOR UNITED STATES OWNERS AND OPERATORS:
Investigational Device. Federal (or US) law limits this device to
investigational use.
The construction of the DC- STIMULATOR conforms to the regulations set out in the
Medical Device Directive 93/42/EEC (Date of issue 14th June 1993), which was put into
German law. The requirements of the following standard(s) or normative document(s) are
fulfilled:
- EN 60601-1:2006 Medical electrical equipment Part 1: General requirements for safety
- EN 60601-1-2:2007 Medical electrical equipment Part 1-2: General requirements for
safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
- EN 62304:2006 Medical device software - Software life-cycle process
- EN 62366:2008 Medical devices - Application of usability engineering to medical devices
- EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process (ISO 10993-1:2009)
- EN ISO 14971:2012 Medical devices - Application of risk management to medical devices