GB/T 19702-2021
In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for content and presentation of reference measurement procedures
- Standard No.
- GB/T 19702-2021
- Language
- Chinese
- Release Date
- 2021
- Published By
- 国家市场监督管理总局、中国国家标准化管理委员会
- Lastest
- GB/T 19702-2021
- Replace
- GB/T 19702-2005
- Scope
- This standard specifies the requirements for the content of reference measurement procedures for in vitro diagnostic medical devices and medical laboratories. Note 1: This standard expects an experienced laboratory worker to operate in accordance with the measurement procedures formulated in accordance with this standard, and can obtain measurement results with measurement uncertainties that do not exceed the specified interval. This International Standard applies to reference measurement procedures that provide differential or proportional quantities. Appendix A provides information on nominal properties and ordinal quantities. This standard applies to all individuals, institutions or institutes that need to write reference measurement program files in various branches of laboratory medicine. Fully described measurement methods are usually published in the scientific literature, and these sufficiently detailed methods can serve as the basis for documented reference measurement procedures. Note 2: In this standard, "international measurement standard" is defined as material standard. The term "International Standard" is used in WHO as a reference material.
GB/T 19702-2021 Referenced Document
- ISO 15194 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation
GB/T 19702-2021 history
- 2021 GB/T 19702-2021 In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for content and presentation of reference measurement procedures
- 2005 GB/T 19702-2005 In vitro diagnostic medical devices.Measurement of quantities in samples of biological origin.Presentation of reference measurement procedures