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SSH EN ISO 15195:2019

Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)

Apr 15, 2021

General information

60.60     Apr 15, 2021

DPS

DPS/KT 140

European Norm

11.100.99  

English  

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Scope

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].

Related directives

Directives related to this standards.

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

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 15195:2005

NOW

PUBLISHED
SSH EN ISO 15195:2019
60.60 Standard published
Apr 15, 2021

Related project

Adopted from EN ISO 15195:2019