ISO 20776-2:2021

недоступно на русском языке

Тезис

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.

Общая информация

Текущий статус
: Опубликовано

Дата публикации
: 2021-12
Версия
: 2
Технический комитет
: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
ICS
:
11.100.20 Biological evaluation of medical devices

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	Формат	Язык
std 1 92	PDF + ePub
std 2 92	Бумажный

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