TÜV SÜD America recognized by OSHA for medical devices
The Occupational Safety & Health Administration (OSHA) recognizes TÜV SÜD America as a Nationally Recognized Testing Laboratory (NRTL) for the testing and certification of medical devices according to the national deviations from the IEC 60601-1 standard in the USA and Canada. OSHA announced this decision in its notice of February 18, 2015.
In both countries, the national adaptations of edition 3.1 of the standard (i.e. IEC 60601-1 including Amendment A1), i.e. ANSI/AAMI ES60601-1:2005/(R) 2012 or CAN/CSA-C22.2 no.60601-1:14 respectively, must be applied.
Testing on behalf of European manufacturers can still be carried out at the testing laboratory of TÜV SÜD Product Service in Munich. The required factory inspections too will be carried out by employees of TÜV SÜD Product Service in Munich.
TÜV SÜD America will subsequently conduct the certification as an organization recognized for medical devices under OSHA’s Nationally Recognized Testing Laboratory Program.
Manufacturers using our NRTL marking based on the 2nd edition of the standard are recommended to update their certification; so far, no transitional period has been established for the use of the previous marking. Further information on NRTL marking is summarized in the Med-Info “Access USA and Canada” [ PDF 770 kB ] (in English).