T/CAS 678-2023 Active Group standards

T/CAS 678-2023 Liquid chromatography-mass spectrometry for clinical drug monitoring general technical requirements

Publish Date: 2023-01-06 Implement Date: 2023-01-06 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 678-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medicine, health, and labor protection

ICS Name: Laboratory medicine

Publish Date: 2023-01-06

Implement Date: 2023-01-06

Scope

Scope: This document specifies the basic requirements for experiments, pre-analysis preparation, method establishment and validation, quality management, and result reporting for clinical therapeutic drug monitoring using liquid chromatography-mass spectrometry (LC-MS) technology. This document is applicable to the quality management of establishing, validating, and operating clinical therapeutic drug monitoring methods using LC-MS technology, as well as the development of related kits. Main technical content: 1. Scope: This document specifies the basic requirements for experiments, pre-analysis preparation, method establishment and validation, quality management, and result reporting for clinical therapeutic drug monitoring using LC-MS technology. This document is applicable to the quality management of establishing, validating, and operating clinical therapeutic drug monitoring methods using LC-MS technology, as well as the development of related kits. 2. Normative reference documents: This document does not have any normative reference documents.