DIN EN 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 t

Standard No.
DIN EN ISO 20776-2:2007
Release Date
2007
Published By
German Institute for Standardization
Status
Replace By
DIN EN ISO 20776-2 E:2021
Latest
DIN EN ISO 20776-2:2022-04
Scope
This part of ISO 20776 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. This part of ISO 20776 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. This part of ISO 20776 has been developed to guide manufacturers in the conduct of performance evaluation studies.

DIN EN ISO 20776-2:2007 Referenced Document

  • ISO 20776-1 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: Refe*2019-06-05 Update

DIN EN ISO 20776-2:2007 history

  • 2022 DIN EN ISO 20776-2:2022-04 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 susceptibilit...
  • 2022 DIN EN ISO 20776-2:2022 Laboratory medical examinations and in vitro diagnostic systems – Susceptibility testing of infectious agents and evaluation of devices for antimicrobial susceptibility testing – Part 2: Evaluation of the performance of test systems for antimicrobial susc
  • 1970 DIN EN ISO 20776-2 E:2021-06 Laboratory medicine examination and in vitro diagnostic systems Susceptibility testing of infectious pathogens and evaluation of antimicrobial susceptibility testing devices Part 2: Evaluating the performance of test systems for antimicrobial susceptibili
  • 2021 DIN EN ISO 20776-2 E:2021 Draft Document - 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 susc...
  • 2007 DIN EN 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 t
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 t



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