YY/T 0688.2-2024 Active
YY/T 0688.2-2024 Clinical laboratory testing and in vitro diagnostic test systems—Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices—Part 2:Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution
Abstract
This document establishes acceptable performance standards for antimicrobial susceptibility testing (AST) equipment. These devices are used in medical laboratories to determine the minimum inhibitory concentration (MIC) of bacteria to antimicrobial drugs.
This document specifies the requirements for AST equipment and the procedures for evaluating the performance of these devices. It provides guidance on how to conduct performance evaluations of AST equipment.
This document is applicable to guiding manufacturers in conducting performance evaluation studies.
General Product Information
| Document Type | Industry standards-Medicine |
|---|---|
| Standard Status | Active |
| Standard Code | YY/T 0688.2-2024 |
| CCS | Medical laboratory equipment |
| ICS | Laboratory medicine |
| Implement Date | 2025-10-15 |