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NBN EN ISO 13485:2016

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

ACTIVE

About this standard

Languages
German, English, French and Dutch
Type
NBN
Status
ACTIVE
Publication date
26 February 2016
Replaces
CEN ISO/TR 14969:2005, NBN EN ISO 13485:2012, NBN EN ISO 13485/AC:2012
Amended By
NBN EN ISO 13485:2016/A11:2021
Corrected By
NBN EN ISO 13485:2016/AC:2017, NBN EN ISO 13485:2016/AC:2018
ICS Code
03.100.70 (Management systems)
11.040.01 (Medical equipment in general)

About this training