T/CI 310-2024 Active Group standards

T/CI 310-2024 Evaluating the blocking agent performance in raw materials for in vitro diagnostic products

Publish Date: 2024-03-25 Implement Date: 2024-03-25 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/CI 310-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Laboratory medicine

Publish Date: 2024-03-25

Implement Date: 2024-03-25

Scope

Main technical content: This document specifies the general requirements for the evaluation of the performance of blockers in the raw materials of in vitro diagnostic products, evaluation methods, basic requirements for blockers, detection procedures, precautions for testing, performance reports, and changes and reassessments in performance evaluation studies. This document is applicable to the performance evaluation of blockers in in vitro diagnostic products, based on qualitative or quantitative measurements and the evaluation of the impact of eliminating interference on in vitro diagnostic detection systems through threshold judgment results.