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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

General information
Valid from 23.12.2021
ICS Groups
11.100.20 Biological evaluation of medical devices
Directives or regulations
None

Standard history

Status
Date
Type
Name
23.12.2021
Main
ISO 20776-2:2021
14.06.2007
Main
ISO 20776-2:2007
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.
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PDF
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Paper
125.87 € incl tax
Standard monitoring
English

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English

Contact

standard@evs.ee
+372 605 5060
Akadeemia tee 21/6, Tallinn, 12618, Estonia
Reg. code 80120020
Eesti Standardimis- ja Akrediteerimiskeskus MTÜ
E-N 8:30-17:00 R 8:30-16:00

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