SS-EN-ISO-20776-2 › 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 (ISO 20776-2:2021)
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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.
To find similar documents by classification:
11.100.10 (In vitro diagnostic test systems)
11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)
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Designation Name
SS-EN ISO 20776-2:2022
Revision Level
2022 EDITION
Status
Current
Publication Date
Jan. 24, 2022
Language(s)
English
Page Count
28
International Equivalent
EN ISO 20776-2:2022(IDT); ISO 20776-2:2021(IDT)