ISO 14971

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ISO 14971 is an ISO standard, of which the latest revision was published in 2012, that details the requirements for application of a risk management system for medical devices.[1]

This standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle. Such activity is required by higher level regulation and other quality standards such as ISO 13485.

This standard adopted by CEN as EN ISO 14971:2012 is harmonized with respect to the European Medical Devices Directive 93/42/EEC.[2]

EN ISO 14971:2012 applies only to manufacturers with devices intended for the European market; for the rest of the world, ISO 14971:2007 remains the standard recommended for risk management purposes.

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