GB/T 29790-2020
ActivePoint-of-care testing(POCT)—Requirements for quality and competence
即时检验 质量和能力的要求
Application Summary AI generated
This standard specifies quality management and competence requirements for point-of-care testing (POCT), covering the entire testing process from pre-examination to post-examination. It is applied in clinical settings such as hospital wards, emergency rooms, and outpatient clinics where rapid diagnostic tests are performed near the patient, rather than in a central laboratory. The standard ensures reliable test results by defining personnel training, equipment maintenance, and quality control procedures for POCT devices used in medical diagnostics.
Related Standards
GB/T 2828.1-2012
Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
GB/T 19000-2008/ISO 9000:2005
Quality management systems - Fundamentals and vocabulary
GB/T 19004-2011
Managing for the sustained success of an organization — Quality management approach
GB/T 19011-2013
Guidelines for auditing management systems
GB/T 2828.1-2003
Sampling procedures for inspection by attributes--Part 1: Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection
GB/T 19022-2003
Measurement management systems--Requirements for measurement processes and measuring equipment
GB/T 6379.1-2004
Accuracy(trueness and precision)of measurement methods and results--Part 1:General principles and definitions
GB/T 6379.2-2004
Accuracy(trueness and precision)of measurement methods and results--Part 2:Basic method for the determination of repeatability and reproducibility of a standard measurement method
Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.