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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

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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.

Replacement amendments

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 .

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