IEC 60601-1 Ed 3.1 – Risk Management And General Requirements


Course Description:

This second course in the IEC 60601-1 Edition 3.1 compliance program offers an in-depth review of risk management’s function in the standard. It also examines the relationship between IEC 60601-1 Edition 3.1 and the ISO 14971 risk management standard for medical devices.

The latter part of this course reviews the general requirements needed to move onto the next courses (which cover more practical aspects of the standard).

The following general requirements are covered:

Philosophy of the standard
Classifications
Basic terminology
Markings on the inside and outside of the equipment
Markings of controls and instruments
Safety signs
Indicator lights
Accompanying documents

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