What regulatory standards do 3D Guidance trackers meet?
REGULATORY A. medSAFE is a Class 1 medical device per IEC 60601-1. Its sensors are designed and tested to the Type CF, Defib Proof Applied Part designation. The system complies with electrical, safety, and electromagnetic compatibility requirements set forth in IEC 60601-1 and –2. driveBAY and trakSTAR are Class 1 medical devices per IEC 60601-1. Their sensors meet Type B Applied Part standards. They also carry the CE mark and meet IEC 60601-1-2, Class B Limits for EMC.
