EN ISO 15189:2022/A11:2023

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

Publication date: Feb 19, 2024

General information

Current stage: 60.60 Standard published Nov 15, 2023

Originator: CEN

Owner: CEN/TC 140 In vitro diagnostic medical devices

Type: European Norm

ICS: 03.120.10 Quality management and quality assurance | 11.100.01 Laboratory medicine in general

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Status: Published

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

PREVIOUSLY

PUBLISHED
EN ISO 15189:2022

NOW

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