![]() ![]() ![]() This standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle. In 2013, a technical report ISO/TR 24971 was published by ISO TC 210 to provide expert guidance on the application of this standard. The latest significant revision was published in December 2019. This standard is the culmination of the work starting in ISO/IEC Guide 51, and ISO/IEC Guide 63. The ISO Technical Committee responsible for the maintenance of this standard is ISO/ TC 210 working with IEC/SC62A through Joint Working Group one (JWG1). ISO 14971 Medical devices - Application of risk management to medical devices is an ISO standard for the application of risk management to medical devices.
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