60.60 Standard published Dec 14, 2022
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
Published
This document specifies requirements for quality and competence in medical laboratories.
This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.
This document is also applicable to point-of-care testing (POCT).
NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
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
60.60
Standard published
Dec 14, 2022
PUBLISHED
EN ISO 15189:2022/A11:2023
