Group Standards of the People's Republic of China CN / TUANTI
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T/CAS 819-2024
Scope
1 Scope
This document specifies technical requirements for the design and selection, installation and commissioning, calibration, operation and maintenance, and troubleshooting of clinical laboratory automation systems.
This document applies to management departments in healthcare, various levels and types of medical institutions' laboratories, as well as manufacturers of medical laboratory automation systems for the construction and application of such systems.
Note: In practice, a clinical laboratory is also referred to as a medical laboratory. Hereinafter it will be referred to as "laboratory".
2 Normative references
The contents of the documents listed below are integral parts of this document through normative references in the text. For dated references, only the edition applicable at the relevant date applies. For undated references, the latest edition (including any amendments) applies.
GB4793.1 Safety requirements for electrical equipment used for measurement, control and laboratories - Part 1: General requirements
GB19489 General biological safety requirements for laboratories
GB/T22576.1 Requirements for quality and competence of medical laboratories - Part 1: General requirements
GB/T42060 Requirements for sample collection, transport, receipt and processing in medical laboratories
WS434 Operation management of power systems in hospitals
WS/T616 Automatic review of quantitative test results in clinical laboratories
WS/T654 Safety management of medical devices
T/CAS 819-2024 history
2024T/CAS 819-2024 General technical requirements for clinical laboratory automation system