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EN ISO 20776-2:2022

(Main)

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 (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 (ISO 20776-2:2021)

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.

Labormedizinische Untersuchungen und In vitro-Diagnostika-Systeme - Empfindlichkeitsprüfung von Infektionserregern und Evaluation von Geräten zur antimikrobiellen Empfindlichkeitsprüfung - Teil 2: Evaluation der Leistung von Testsystemen zur antimikrobiellen Empfindlichkeitsprüfung im Vergleich zur Referenzmethode der Bouillon-Mikrodilution (ISO 20776 2:2021)

Dieses Dokument legt annehmbare Leistungskriterien für Testsysteme zur Prüfung der mikrobiellen Empfind¬lichkeit (AST, en: antimicrobial susceptibility test) fest, die zur Bestimmung der minimalen Hemmkonzen¬trationen (MHK) von Bakterien auf antimikrobielle Substanzen in medizinischen Laboren verwendet werden.
Dieses Dokument legt Anforderungen an Testsysteme zur Prüfung der mikrobiellen Empfindlichkeit sowie Verfahren zur Leistungsbewertung dieser Testsysteme fest. Es legt fest, wie eine Leistungsbewertung eines Testsystems zur Prüfung der mikrobiellen Empfindlichkeit durchzuführen ist.
Dieses Dokument wurde mit dem Ziel erarbeitet, Hersteller bei der Durchführung von Leistungsbewertungs¬studien anzuleiten.

Systèmes d'essais en laboratoire et de diagnostic in vitro - Sensibilité in vitro des agents infectieux et évaluation des performances des dispositifs pour antibiogrammes - Partie 2: Évaluation des performances des dispositifs pour antibiogrammes par rapport à une méthode de référence de microdilution en bouillon (ISO 20776-2:2021)

Le présent document établit des critères de performances acceptables pour les dispositifs de mesure de sensibilité antimicrobienne (DMSA), qui sont utilisés pour déterminer les concentrations minimales inhibitrices (CMI) de bactéries des agents antimicrobiens dans des laboratoires médicaux.
Le présent document indique les exigences pour les dispositifs DMSA, ainsi que les modes opératoires permettant d’estimer la performance de ces dispositifs. Il définit comment une évaluation des performances d’un dispositif DMSA doit être effectuée.
Le présent document a été développé afin de guider les fabricants dans la réalisation des études d’évaluation des performances.

Klinični laboratorijski preskusi ter diagnostični preskusni sistemi in-vitro - Preskus občutljivosti povzročiteljev infekcij in vrednotenje delovanja antimikrobno občutljivih preskusnih naprav - 2. del: Vrednotenje delovanja antimikrobno občutljivih naprav (ISO 20776-2:2021)

Ta dokument določa kriterije sprejemljivega delovanja antimikrobno občutljivih naprav (AST), ki se uporabljajo za določevanje minimalnih inhibicijskih koncentracij (MIC) antimikrobnih sredstev za bakterije v zdravstvenih laboratorijih.
Ta dokument določa zahteve za antimikrobno občutljive naprave in postopke za ocenjevanje njihovega
delovanja. Opredeljuje način vrednotenja delovanja antimikrobno občutljive naprave.
Ta dokument je bil pripravljen za usmerjanje proizvajalcev pri izvajanju študij vrednotenja
delovanja.

General Information

Status
Published
Publication Date
18-Jan-2022
ICS
11.100.20 - Biological evaluation of medical devices
Technical Committee
CEN/TC 140 - In vitro diagnostic systems
Drafting Committee
CEN/TC 140 - In vitro diagnostic systems
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
19-Jan-2022
Completion Date
19-Jan-2022
Ref Project
SIST EN ISO 20776-2:2022 - 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 (ISO 20776-2:2021)

Relations

Replaces
EN ISO 20776-2:2007 - 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 (ISO 20776-2:2007)
Effective Date
26-Jan-2022

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 20776-2:2022
01-marec-2022
Nadomešča:
SIST EN ISO 20776-2:2008
Klinični laboratorijski preskusi ter diagnostični preskusni sistemi in-vitro -
Preskus občutljivosti povzročiteljev infekcij in vrednotenje delovanja antimikrobno
občutljivih preskusnih naprav - 2. del: Vrednotenje delovanja antimikrobno
občutljivih naprav (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 (ISO 20776-2:2021)
Labormedizinische Untersuchungen und In-vitro-Diagnostika-Systeme -
Empfindlichkeitsprüfung von Infektionserregern und Evaluation von Geräten zur
antimikrobiellen Empfindlichkeitsprüfung - Teil 2: Evaluation der Leistung einer
Vorrichtung zur antimikrobiellen Empfindlichkeitsprüfung (ISO 20776-2:2021)
Systèmes d'essais en laboratoire et de diagnostic in vitro - Sensibilité in vitro des agents
infectieux et évaluation des performances des dispositifs pour antibiogrammes - Partie 2:
Évaluation des performances des dispositifs pour antibiogrammes par rapport à une
méthode de référence de microdilution en bouillon (ISO 20776-2:2021)
Ta slovenski standard je istoveten z: EN ISO 20776-2:2022
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
SIST EN ISO 20776-2:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 20776-2:2022

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SIST EN ISO 20776-2:2022


EN ISO 20776-2
EUROPEAN STANDARD

NORME EUROPÉENNE

January 2022
EUROPÄISCHE NORM
ICS 11.100.20 Supersedes EN ISO 20776-2:2007
English Version

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 (ISO 20776-2:2021)
Systèmes d'essais en laboratoire et de diagnostic in Labormedizinische Untersuchungen und In-vitro-
vitro - Sensibilité in vitro des agents infectieux et Diagnostika-Systeme - Empfindlichkeitsprüfung von
évaluation des performances des dispositifs pour Infektionserregern und Evaluation von Geräten zur
antibiogrammes - Partie 2: Évaluation des antimikrobiellen Empfindlichkeitsprüfung - Teil 2:
performances des dispositifs pour antibiogrammes par Evaluation der Leistung einer Vorrichtung zur
rapport à une méthode de référence de microdilution antimikrobiellen Empfindlichkeitsprüfung (ISO 20776-
en bouillon (ISO 20776-2:2021) 2:2021)
This European Standard was approved by CEN on 16 December 2021.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20776-2:2022 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
SIST EN ISO 20776-2:2022
EN ISO 20776-2:2022 (E)
Contents Page
European foreword . 3

2

---------------------- Page: 4 ----------------------
SIST EN ISO 20776-2:2022
EN ISO 20776-2:2022 (E)
European foreword
This document (EN ISO 20776-2:2022) has been prepared by Technical Committee ISO/TC 212 "Clinical
laboratory testing and in vitro diagnostic test syst
...

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