<p>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.</p>
<p>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.</p>
<p>This document has been developed to guide manufacturers in the conduct of performance evaluation studies.</p>
Registration number (WIID)
79377
Scope
<p>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.</p>
<p>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.</p>
<p>This document has been developed to guide manufacturers in the conduct of performance evaluation studies.</p>
