BSI 21/30425530 DC:2021 Edition
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BS 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 – Part 2. Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution
Published By | Publication Date | Number of Pages |
BSI | 2021 | 25 |
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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.
Status | Definitive |
---|---|
Pages | 25 |
Publication Date | 2021-04-30 |
Standard Number | 21/30425530 DC |
Title | BS 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 – Part 2. Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution |
Identical National Standard Of | ISO/DIS 20776-2 |
Descriptors | Testing conditions, Performance testing, Clinical medicine, Diagnosis (medical), Microorganisms, Clinical testing, Laboratory testing, Biological analysis and testing, Bacteria, Pathogens, Biological hazards, Drugs, Antibiotics |
Publisher | BSI |
Committee | CH/212 |
ICS Codes | 11.100.20 - Biological evaluation of medical devices |
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