YY/T 2001-2026 In vitro diagnostic test systems—Requirements for preparing manufacturer's reference materials for qualitative detection reagents

Scope

This document specifies the general requirements for reference materials of qualitative detection in vitro diagnostic reagents (hereinafter referred to as "enterprise reference materials") and the specific settings of positive reference materials, negative reference materials, detection limit reference materials, and precision reference materials.
This document applies to the setting of enterprise reference materials used for quality control of qualitative detection in vitro diagnostic reagents.
This document does not apply to reagents for microbial identification or drug sensitivity testing, or cell culture media used for cell selection, induction, and differentiation.

Development Information

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