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SSH EN ISO 15195:2005

Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003)

Apr 1, 2005
95.99 Withdrawal of Standard   Apr 15, 2021

General information

95.99     Apr 15, 2021

DPS

DPS/KT 206

European Norm

03.120.20     11.100  

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Scope

ISO 15195:2003 gives the specific requirements for reference measurement laboratories in laboratory medicine. Examinations of properties with results reported on a nominal or ordinal scale are not included.
ISO 15195:2003 is not applicable to routine medical laboratories.
The general requirements for the competence of calibration laboratories are laid down in ISO/IEC 17025 for testing and calibration laboratories. ISO 15195:2003 refers to the specific aspects of calibration laboratories in the field of laboratory medicine where such "calibration laboratories" are usually denoted as "reference measurement laboratories".
ISO 15195:2003 may form a basis for the accreditation of a reference measurement laboratory that applies for official recognition of the performance of a reference measurement procedure. Reference measurement laboratories are usually accredited by national metrology institutes or national accrediting bodies.

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

NOW

WITHDRAWN
SSH EN ISO 15195:2005
95.99 Withdrawal of Standard
Apr 15, 2021

REVISED BY

PUBLISHED
SSH EN ISO 15195:2019

Related project

Adopted from EN ISO 15195:2003