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IEC 62366-1 / IEC/TR 62366-2 - Medical Devices Package

IEC 62366-1 and IEC/TR 62366-2

IEC 62366-1 / IEC/TR 62366-2 - Medical Devices Package provides assistance with the proper use of medical devices as it pertains to human risk factors. It specifies safety related processes to analyze, develop, and evaluate the usability of medical devices. The IEC 62366-1 / IEC/TR 62366-2 - Medical Devices Package is applicable to "normal" medical devices usage and is supported with guidance information. IEC 62366-1 / IEC/TR 62366-2 - Medical Devices Package includes:
IEC 62366-1 Ed. 1.0 b:2015
IEC 62366-1 Ed. 1.0 b cor:1:2016
IEC 62366-1 Amd.1 Ed. 1.0 b:2020
IEC/TR 62366-2 Ed. 1.0 en:2016

IEC 62366-1 / IEC/TR 62366-2 - Medical Devices Package includes:


Content Provider
International Electrotechnical Commission [iec]


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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

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