GB/T 19703-2005
In vitro diagnostic medical devices-Measurement of quantities in samples of biological origin-Description of reference materials (English Version)
- Standard No.
- GB/T 19703-2005
- Language
- Chinese, Available in English version
- Release Date
- 2005
- Published By
- General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
- Status
- 2021-12
- Replace By
- GB/T 19703-2020
- Latest
- GB/T 19703-2020
- Scope
- This standard specifies the requirements and format for the description of reference substances. This standard applies to reference materials at a higher metrological level, which can be classified as primary measurement standards and secondary measurement standards, and are used as calibrators or control substances for reference measurement procedures. This standard does not apply to reference substances that are part of in vitro diagnostic measurement systems. This International Standard also provides the procedure for collecting the basic data for determining the value and the method for issuing the assigned value. This standard also specifies the certificate format. This standard does not apply to the production process of these reference materials.
GB/T 19703-2005 history
- 2020 GB/T 19703-2020 In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for certified reference materials and the content of supporting documentation
- 2005 GB/T 19703-2005 In vitro diagnostic medical devices-Measurement of quantities in samples of biological origin-Description of reference materials
