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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: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution
분야 | ISO/TC 212 : Clinical laboratory testing and in vitro diagnostic test systems |
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적용범위 | 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. |
국제분류(ICS)코드 | 11.100.20 : 의료 장비의 생물학적 평가 |
페이지수 | 16 |
Edition | 2 |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
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1 | 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: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution | 2021-12-23 | 표준 |
2 | ISO 20776-2:2007 | 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 | 2007-06-14 | 구판 |
ISO 20776-1:2019 - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases 상세보기
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