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EN ISO 15189:2022/A11:2023

Medical laboratories - Requirements for quality and competence EN ISO 15189:2022/A11:2023

Publication date:   Feb 19, 2024

General information

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

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Related legislation

Legislation related to this standard

765/2008

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
Legislation 765/2008

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 15189:2022

NOW

PUBLISHED
EN ISO 15189:2022/A11:2023
60.60 Standard published
Nov 15, 2023