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NBN EN ISO 13485:2016

Medische hulpmiddelen – Kwaliteitsmanagementsystemen – Eisen voor reguleringsdoeleinden (ISO 13485:2016) (Corrected version, 2016-12-21)

ACTIVE

Languages: German, English, French and Dutch
Type: NBN
Standards committee: CEN/CLC/JTC 3 (Quality management and corresponding general aspects for medical devices)
Status: ACTIVE
Publication date: 26 February 2016
Replaces: CEN ISO/TR 14969:2005
Amended By: NBN EN ISO 13485:2016/A11:2021
Corrected By: NBN EN ISO 13485:2016/AC:2017 NBN EN ISO 13485:2016/AC:2017
ICS Code: 03.100.70 (Managementsysteem)
11.040.01 (Medische hulpmiddelen, algemeen)
Withdrawn Date
Price: € 166,00