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Medical Product Safety
The major safety standard for electro-medical devices is the IEC 60601 series with the European equivalent of the EN 60601 series.IEC 60601-1 covers all generic requirements including a list of hazards and their tolerable limit of risk.
IEC 60601-1-X collateral standard series deals with issues such as electric medical systems, EMC, x-ray protection and programmable electrical medical systems, and shall be used in conjunction with the IEC/EN 60601-1.
IEC 60601-2-X series defines requirements for specific medical devices and shall be used in conjunction with IEC 60601-1. The US deviations to IEC 60601-1 are defined in UL 2601-1, which is used as the basis for the NRTL mark. TUV Rheinland issues CTUVus marks based on UL2601-1 in combination with the Canadian CAN/CSA C22.2.601.1 standard which describes Canadian deviations to IEC 60601-1.
The cTUVus mark, the T-Mark and the Bauart mark can also be issued after successful testing against applicable standards.
TUV Rheinland of North America, Inc. can provide test reports for your technical files (Europe & EU Approvals) and FDA approval submission (US).
Note: Based on legal stipulations, no GS Mark can be issued for medical devices.
