ISO 14971 Medical Device Risk Management is a risk management standard for medical devices and in vitro diagnostic medical devices. The ISO/TC210 and IEC/SC62A technical groups issued the ISO 14971 technical standard in 2000 to carry out risk management throughout the entire lifecycle of medical devices. After years of application, this standard has been recognized by most medical device regulatory authorities and is the best standard for medical device risk management.
Based on the experience of using the standard and the requirements of medical device regulatory agencies, ISO14971:2019 was released in December 2019. This standard requires applicability to all stages of the product lifecycle from concept to later production, emphasizing the expected benefits of medical device use, further balancing the relationship between device risks and benefits, and requiring greater clarity and specificity to enhance the readability and usability of the standard.