GB/T 21919-2008
Laboratory medicine.Requirements for reference measurement laboratories (English Version)
- Standard No.
- GB/T 21919-2008
- Language
- Chinese, Available in English version
- Release Date
- 2008
- Published By
- General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
- Status
- 2023-05
- Replace By
- GB/T 21919-2022
- Latest
- GB/T 21919-2022
- Scope
- This standard specifies the special requirements for laboratory medical reference measurement laboratories. This International Standard does not cover measurements of properties that report results on a nominal or ordinal scale. This standard is not applicable to routine medical laboratories. NOTE 1: Laboratories are responsible for complying with relevant legal health and safety requirements. NOTE 2 Requirements for routine medical laboratories are specified in ISO 15189.
GB/T 21919-2008 Referenced Document
- GB/T 19702-2005 In vitro diagnostic medical devices.Measurement of quantities in samples of biological origin.Presentation of reference measurement procedures
- GB/T 19703-2005 In vitro diagnostic medical devices-Measurement of quantities in samples of biological origin-Description of reference materials
- GB/T 21415-2008 In vitro diagnostic medical devices.Measurement of quantities in biological samples.Metrological traceability of values assigned to calibrators and control materials
- ISO ISO IEC 27001-2013 cor2-2015 technical errata*， 2024-04-19 Update
- YY/T 0638-2008 In vitro diagnostic medical devices.Measurement of quantities in biological samples.Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials
GB/T 21919-2008 history
- 2022 GB/T 21919-2022 Laboratory medicine—Requirements for the competence of calibration laboratories using reference measurement procedures
- 2008 GB/T 21919-2008 Laboratory medicine.Requirements for reference measurement laboratories
