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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

Standard Details

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.

General Information

Status : WITHDRAWN
Standard Type: Main
Document No: ISO 20776-2:2007
Document Year: 2007
Pages: 9
Edition: 1
  • Section Volume:
  • ISO/TC 212. Clinical laboratory testing and in vitro diagnostic test systems
  • ICS:
  • 11.100.20 Biological evaluation of medical devices

Life Cycle

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WITHDRAWN
ISO 20776-2:2007
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