In medical procedures, there is no such thing as zero risk. In the best case, we can minimize the risks. One possible way is to apply robust risk management processes to medical devices and equipment. It is with this in mind that the international standard ISO 14971, provided for this purpose, has been updated.The international ISO 14971 standard “Medical products. Application of risk management to medical devices ”, defines the terminology, principles and processes for managing risks associated with medical devices, including“ software used as medical devices ”or SaMD (software as medical device), as well as in vitro diagnostic medicines (IVD).
This standard, primarily intended for manufacturers of medical devices, is designed to ensure the safety of devices and equipment used for medical purposes. In particular, it provides rules for the prevention of risks of injury to the patient, operator and other persons, as well as damage to property, equipment and the environment.The purpose of the revision of ISO 14971 was to define the technical requirements of the standard by including more detailed information on the activities that manufacturers must carry out to meet these requirements. It also includes updating terminology, as well as introducing new terms that reflect current market needs. The manual was transferred to the technical report accompanying the standard, namely ISO / TR 24971 “Medical devices. Directives related to ISO 14971 ”, which was revised in parallel.For advice on the application of ISO 14971, ISO 13485, ISO 15189 and other ISO standards, please contact the SIC International Certification System, expert Pavel Matyushko, firstname.lastname@example.org