This standard specifies the special requirements applicable to point-of-care testing (POCT), and is used in conjunction with GB/T 22576.1-2018. The requirements of this standard are applicable to immediate inspections performed in hospitals, clinics or medical institutions that provide mobile medical services. This standard can be applied to transcutaneous measurement, breath analysis and in vivo monitoring of physiological parameters. This standard does not include patient self-tests performed at home or in the community, but elements of this standard are applicable. Note: Local, regional and national regulations need to be considered.
GB/T 29790-2020 Referenced Document
GB/T 22576.1-2018 Medical laboratories—Requirements for quality and competence—Part 1: General requirements
GB/T 29790-2020 history
2020GB/T 29790-2020 Point-of-care testing(POCT)—Requirements for quality and competence
2013GB/T 29790-2013 Point-of-care testing (POCT).Requirements for quality and competence