EVS-EN ISO 14971:2019/A11:2021

ISO 14971 specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The main text and the consolidated version which consists of main text and the amendment can be found in the standard’s history. EN ISO 14971:2019/A11:2021 modifies the European standard EN ISO 14971:2019. EN ISO 14971:2019/A11:2021 supports the requirements of EU Regulations.

The relationship with EU Regulations can be found in informative annexes:

— Annex ZA covers the relationship between EVS-EN ISO 14971 and the General Safety and Performance Requirements of Regulation (EU) 2017/745.

— Annex ZB covers the relationship between EVS-EN ISO 14971 and the General Safety and Performance Requirements of Regulation (EU) 2017/746.