T/ZJATA 0012-2022 Active Group standards

T/ZJATA 0012-2022 Thrombelastograph (TEG) machine

Publish Date: 2022-11-01 Implement Date: 2022-11-30 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/ZJATA 0012-2022

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Diagnostic equipment

Publish Date: 2022-11-01

Implement Date: 2022-11-30

Scope

Scope: This standard specifies the models and codes of thromboelastography instruments (hereinafter referred to as the instruments), raw material requirements, technical requirements, test principles, test methods, inspection rules, marking, packaging, transportation, storage, and quality commitments. This standard applies to the quality control of thromboelastography instruments during procurement, production, and sales. Main technical content: This standard includes technical requirements, test principles, test methods, inspection rules, marking, packaging, transportation, and storage. It provides a more comprehensive and systematic evaluation of product safety and effectiveness, and unifies technical parameters. The standard uses simulated blood samples for testing as quality control materials to determine the reaction time (R) required for the blood sample to start functioning and the first detectable blood clot formation, the clot formation time (K), the dynamic characteristics of clot formation (ANG), and the maximum amplitude (MA). The accuracy range is superior to or equivalent to that of similar foreign products.