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ISO 14971 is an ISO standard, of which the latest revision was published in 2007, that represents the requirements for 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 14971:2007 is harmonized with respect to the European Medical Devices Directive 93/42/EEC.

See also

• List of ISO standards
• ISO 13485
• Medical technology
• Medical device
• Medical Devices Directive
• Clinical Engineering
• System suitability test
• ISO 690

References

External links

• ISO 13485 International Organization for Standardization