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.

To our valued customers,

At last: 

Beuth Verlag is now DIN Media. 

You can find out more about our new name and the reasons behind it here.

To use our new website without any hiccups, please clear your browser cache. 

Yours sincerely,

DIN Media

Standards Worldwide
Standards Worldwide
Phone +49 30 58885700-07

Standard [CURRENT]

DIN EN ISO 13485:2021-12

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021

German title
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2016); Deutsche Fassung EN ISO 13485:2016 + AC:2018 + A11:2021
Publication date
2021-12
Original language
German
Pages
79

Please select

from 169.10 EUR VAT included

from 158.04 EUR VAT excluded

Purchasing options

PDF download

  • 169.10 EUR

  • 202.90 EUR

  • 211.20 EUR

Shipment (3-5 working days)

  • 204.60 EUR

  • 255.50 EUR

Standards Ticker 1
1

Learn more about the standards ticker

Online service subscriptions

This document also features in an online service. Online services not only give you electronic access to collections of standards, they contain lots of extra information too (such as directives, legal texts, commentaries, etc.). There are automatic updates on a regular basis – and online services also give you large savings compared with the cost of purchasing standards individually.

Suitable online services
Publication date
2021-12
Original language
German
Pages
79
DOI
https://dx.doi.org/10.31030/3223237

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

Content
ICS
03.100.70, 11.040.01
DOI
https://dx.doi.org/10.31030/3223237
Replacement amendments

This document replaces DIN EN ISO 13485 Berichtigung 1:2017-07 , DIN EN ISO 13485:2016-08 .

Cooperation at DIN

Also available in
Relationship to other standards
This document references:
Show all 54
This document is referenced in:
Loading recommended items...
Loading recommended items...
Loading recommended items...
Loading recommended items...