Shopping Cart
Cart is Empty
PS 3944-2-2025
Active
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
Committee:
Medical Laboratories
Sector:
Health and Personal Care
Available Standards
Original Standard
إنجليزي (English)
26
Page
2025
International Classification for Standards (ICS)
| Code | Classification |
|---|---|
| 11.100.20 | Biological evaluation of medical devices |
Adopted Standards
| Standards / Amendment / Corrigendum | |
|---|---|
| 1 | ISO 20776-2:2021 |
Scope
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.