ISO 14971 Basic Concepts – Hazard, Hazardous Situation and Harm
Exeed Regulatory Compliance
FEBRUARY 24, 2020
If your organization has implemented ISO 14971, the International Standard for Risk Management , there is a good chance you are already familiar with these terms. These are very basic terms used for analyzing safety risks associated with a medical device. 1) Hazard ISO 14971 defines a hazard as a potential source of harm.
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