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ISO 20776-2:2007

Withdrawn

Withdrawn

View Superseded by

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

Available format(s)

Hardcopy , PDF

Language(s)

English, French, Russian

Published date

06-14-2007

Withdrawn date

04-09-2025

Superseded by

ISO 20776-2:2021

US$96.00
Excluding Tax where applicable

ISO 20776-2:2007 establishes acceptable performance criteria for antimicrobial susceptibility test (AST) devices that are used to determine minimum inhibitory concentrations (MIC) and/or interpretive category determinations of susceptible, intermediate and resistant (SIR) strains of bacteria to antimicrobial agents in medical laboratories. ISO 20776-2:2007 specifies requirements for AST devices (including diffusion test systems) and procedures for assessing performance of such devices. It defines how a performance evaluation of an AST device is to be conducted. ISO 20776-2:2007 has been developed to guide manufacturers in the conduct of performance evaluation studies.

Committee
ISO/TC 212
DevelopmentNote
Supersedes ISO/DIS 20776-2. (06/2007)
DocumentType
Standard
Pages
9
PublisherName
International Organization for Standardization
Status
Withdrawn
SupersededBy

S.R. CEN ISO/TR 24971:2020 Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
CLSI M52:2010(R2020) Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems

ISO 20776-1:2006 Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases

US$96.00
Excluding Tax where applicable