ISO 20776-2:2007
Withdrawn
View Superseded by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
Hardcopy , PDF
English, French, Russian
06-14-2007
04-09-2025
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Withdrawn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 |
| Standards | Relationship |
| NF EN ISO 20776-2 : 2007 | Identical |
| GOST R ISO 20776-2 : 2010 | Identical |
| NBN EN ISO 20776-2 : 2007 | Identical |
| NEN EN ISO 20776-2 : 2007 | Identical |
| NS EN ISO 20776-2 : 1ED 2007 | Identical |
| I.S. EN ISO 20776-2:2007 | Identical |
| AS ISO 20776.2:2017 | Identical |
| SS-EN ISO 20776-2 : 2007 | Identical |
| PN-EN ISO 20776-2:2007 | Identical |
| BS EN ISO 20776-2:2007 | Identical |
| EN ISO 20776-2:2007 | Identical |
| DIN EN ISO 20776-2:2007-09 | Identical |
| UNE-EN ISO 20776-2:2008 | Identical |
| 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 |