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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

ISO 20776-2:2021

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

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.

This document is available in electronic format only.

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Details

Date of Publication: December 1, 2021

Order Code PDF: ISO207762E

Order Code Print: print not available

Edition: Second

Pages: 16

ISO 20776-2:2021 Additional Details

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Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems.