T/CAS 819-2024 Active Group standards

T/CAS 819-2024 General technical requirements for clinical laboratory automation systems

Publish Date: 2024-02-01 Implement Date: 2024-02-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CAS 819-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medicine, health, and labor protection

ICS Name: Laboratory medicine

Publish Date: 2024-02-01

Implement Date: 2024-02-01

Scope

Scope: This document specifies the technical requirements for the design and selection, installation and commissioning, calibration, operation, and maintenance, as well as fault handling of clinical laboratory automation systems. This document is applicable to the management of medical administration departments, laboratories of all levels and types of medical institutions, and manufacturers of automation systems for the construction and application of medical laboratory automation systems. Note: In practice, clinical laboratories are also referred to as medical laboratories, hereinafter referred to as laboratories. Main technical content: 1. Scope: This document specifies the technical requirements for the design and selection, installation and commissioning, calibration, operation, and maintenance, as well as fault handling of clinical laboratory automation systems. This document is applicable to the management of medical administration departments, laboratories of all levels and types of medical institutions, and manufacturers of automation systems for the construction and application of medical laboratory automation systems. Note: In practice, clinical laboratories are also referred to as medical laboratories, hereinafter referred to as laboratories. 2. Normative reference documents: The contents of the following documents are essential provisions of this document through normative references in the text. Among them, the reference documents with a date are applicable to this document only for the version corresponding to that date; the reference documents without a date are applicable to this document for the latest version (including all amendment sheets). GB 4793.1 Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements GB 19489 General requirements for biosafety in laboratories GB/T 22576.1 Requirements for quality and competence of medical laboratories – Part 1: General requirem