This document establishes acceptable performance criteria for antimicrobial susceptibility test (AST) devices that are used to determine minimum inhibitory concentrations (MIC) of bacteria to antimicrobial agents in medical laboratories.
This document specifies requirements for AST devices and procedures for assessing performance of such devices. It defines how a performance evaluation of an AST device is to be conducted.
This document has been developed to guide manufacturers in the conduct of performance evaluation studies.
Status: PublishedPublication date: 2021-12
Edition: 2Number of pages: 16
Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
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