• Hydrogen Technologies Standards form the basic framework for market ramp-up

    More information

  • Climate change Standards and specifications support climate targets

    More information

  • Smart Farming Standards and specifications are drivers for the digitalization of agriculture

    More information
 
Standards [Withdrawn]

DIN EN ISO 13485 Berichtigung 1
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016, Corrigendum to DIN EN ISO 13485:2016-08; German version EN ISO 13485:2016/AC:2016

Title (German)

Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2016); Deutsche Fassung EN ISO 13485:2016, Berichtigung zu DIN EN ISO 13485:2016-08; Deutsche Fassung EN ISO 13485:2016/AC:2016

Document: references other documents

Responsible national committee

NA 176-01-02 AA - Quality management and corresponding general aspects for medical devices  

Responsible european committee

CEN/CLC/JTC 3 - Quality management and corresponding general aspects for medical devices  

Responsible international committee

ISO/TC 210/WG 1 - Application of quality systems to medical devices  

Edition 2017-07
Original language German
Order from DIN Media
Table of contents

Contact

Dipl.-Ing.

Margarethe Boresch

Am DIN-Platz, Burggrafenstr. 6
10787 Berlin

Tel.: +49 30 2601-2413
Fax: +49 30 2601-42413

Send message to contact