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Glavni meni

ISO 20776-2:2021

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
23. 12. 2021.

Опште информације

60.60     23. 12. 2021.

ISO

ISO/TC 212

Međunarodni standard

11.100.20  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 20776-2:2007

TRENUTNO

OBJAVLJEN
ISO 20776-2:2021
60.60 Standard objavljen
23. 12. 2021.

Nacionalna preuzimanja

Kliničko laboratorijsko ispitivanje i in vitro dijagnostički sistemi ispitivanja – Ispitivanje osetljivosti infektivnih agensa i vrednovanje performansi uređaja za ispitivanje antimikrobne osetljivosti – Deo 2: Vrednovanje performansi uređaja za ispitivanje antimikrobne osetljivosti u odnosu na referentnu metodu mikrorazblaživanja bujona

60.60   Standard objavljen