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60.60 Standard published Feb 6, 2019
CEN
CEN/TC 140 In vitro diagnostic medical devices
European Norm
11.100.99 Other standards related to laboratory medicine
Published
This document specifies the requirements for competence to carry out reference measurement procedures in laboratory medicine, using the requirements of ISO/IEC 17025:2017 as a normative reference and listing additional requirements for calibration laboratories to perform their tasks adequately.
The relationship between clauses in this document and ISO/IEC 17025:2017 are summarized in Annex A.
Examinations of properties with results reported on a nominal or ordinal scale are not included.
This document is not applicable to medical laboratories.
NOTE Requirements for medical laboratories are specified in ISO 15189[1].
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
WITHDRAWN
EN ISO 15195:2003
PUBLISHED
EN ISO 15195:2019
60.60
Standard published
Feb 6, 2019