ISO 15195:2003
Laboratory medicine - Requirements for reference measurement laboratories
- Standard No.
- ISO 15195:2003
- Release Date
- 2003
- Published By
- International Organization for Standardization (ISO)
- Status
- Replace By
- ISO 15195:2018
- Latest
- ISO 15195:2018
- Scope
- This International Standard 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. This International Standard is not applicable to routine medical laboratories. NOTE 1 It is the laboratory's responsibility to comply with the relevant legal health and safety requirements. NOTE 2 Requirements for routine medical laboratories are specified in ISO 15189.
ISO 15195:2003 Referenced Document
- ISO 15193 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures*， 2009-05-01 Update
- ISO 15194:2002 In vitro diagnostic systems - Measurement of quantities in samples of biological origin - Description of reference materials
- ISO 17511 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples*， 2020-04-24 Update
- ISO 18153 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
ISO 15195:2003 history
- 2018 ISO 15195:2018 Laboratory medicine — Requirements for the competence of calibration laboratories using reference measurement procedures
- 2003 ISO 15195:2003 Laboratory medicine - Requirements for reference measurement laboratories
