We use cookies to make our websites more user-friendly and to continuously improve them. If you continue to use the website, you consent to the use of cookies. You can find more information in our privacy statement and our cookie guidelines.

Dear customers,

We are saying goodbye for the Easter holidays and will be back in person for you from 22.04.2025.

Please note that new registrations and requests to be processed manually will only be processed from this date.

You can of course place orders and downloads online at any time, and our FAQs provide you with lots of helpful information.

We wish you a happy Easter!

Your DIN Media GmbH

Standards Worldwide
Standards Worldwide
Phone +49 30 58885700-07

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

162.14 EUR VAT included

151.53 EUR VAT excluded

Format and language options

Shipment (3-5 working days)

  • 162.14 EUR

Monitor with the Standards Ticker

This option is only available after login.
Easily subscribe: Save time and money now!

You can also subscribe to this document - together with other important standards in your industry. This makes your work easier and pays for itself after a short time.

Sparschwein_data
Subscription advantages
Sparschwein Vorteil 1_data

Important standards for your industry, regularly updated

Sparschwein Vorteil 2_data

Much cheaper than buying individually

Sparschwein Vorteil 3_data

Useful functions: Filters, version comparison and more

Publication date
2016-10
Original language
German
Pages
101

Product information on this site:

Quick delivery via download or delivery service

Buy securely with a credit card or pay upon receipt of invoice

All transactions are encrypted

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 .

Cooperation at DIN

Relationship to other standards
This document references:
Show all 29
This document is referenced in:
Loading recommended items...
Loading recommended items...
Loading recommended items...
Loading recommended items...