Overview

This standard defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes. This standard applies to the development and maintenance of medical device software when the software itself is a medical device or when the software is an embedded or integral part of the finished medical device. The responsible subcommittee is DKE/UK 811.3 "Sicherheit von medizinisch genutzten Geräten/Systemen/Einrichtungen in der vernetzten Anwendung" ("Safety of medical devices/systems/facilities for network applications") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN.

Document: references other documents

Document: referenced in other documents

Responsible national committee

DKE/UK 811.3 - Sicherheit von medizinisch genutzten Geräten/Systemen/Einrichtungen in der vernetzten Anwendung  

Responsible international committee

ISO/TC 210/JWG 2 - Joint ISO/TC 210-IEC/SC 62A WG : Medical device software