GOST R 59766-2021 - Std. & Spec

Scope: This standard establishes a risk categorization system that applies to software as a medical device that falls within the appropriate definition [see [1]], and does not apply to other types of software. Software intended as an accessory to a medical device (i.e. software that does not itself have a medical purpose) is not within the scope of this standard. This standard considers software as a medical device regardless of the software technology or platform (e.g., mobile applications, cloud, server). This standard does not apply to software that controls or ensures the correct functioning of the hardware of a medical device. This standard is not intended to replace or create new risk management techniques, but rather to use risk management principles (e.g., those established in International Standards) to identify general risks for software as a medical device.

GOST R 59766-2021 history

2021 GOST R 59766-2021 Software as a medical device. Possible framework for risk categorization and corresponding considerations