60.60 Standard published Nov 15, 2023
CEN
CEN/TC 140 In vitro diagnostic medical devices
European Norm
03.120.10 Quality management and quality assurance | 11.100.01 Laboratory medicine in general
Legislation related to this standard
REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93
Harmonized/Supporting
PUBLISHED
EN ISO 15189:2022
PUBLISHED
EN ISO 15189:2022/A11:2023
60.60
Standard published
Nov 15, 2023