Laboratorní medicína, klinická patologie a biologická bezpečnost

Komise : CEN/TC 140 (In vitro diagnostic medical devices)
Původce: CEN
K připomínkám do: 3.06.2018
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This International Standard 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 international standard 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 International Standard is not applicable to medical laboratories.

NOTE 1       It is the laboratory’s responsibility to comply with the relevant legal health and safety requirements.

NOTE 2       Requirements for medical laboratories are specified in ISO 15189.