Standard [CURRENT]
DIN EN 62304:2016-10
VDE 0750-101:2016-10
Medical device software - Software life-cycle processes (IEC 62304:2006 + A1:2015); German version EN 62304:2006 + Cor.:2008 + A1:2015
- German title
- Medizingeräte-Software - Software-Lebenszyklus-Prozesse (IEC 62304:2006 + A1:2015); Deutsche Fassung EN 62304:2006 + Cor.:2008 + A1:2015
- Publication date
- 2016-10
- Original language
- German
- Pages
- 101
- Publication date
- 2016-10
- Original language
- German
- Pages
- 101
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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.
This document replaces DIN EN 62304 Berichtigung 1:2009-05; VDE 0750-101 Berichtigung 1:2009-05 , DIN EN 62304:2007-03; VDE 0750-101:2007-03 .
This document has been corrected by: DIN EN 62304 Berichtigung 1:2026-04; VDE 0750-101 Berichtigung 1:2026-04 .