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)

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

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
European foreword . 3

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 systems" in collaboration with Technical Committee
CEN/TC 140 “In vitro diagnostic medical devices” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by July 2022, and conflicting national standards shall be
withdrawn at the latest by January 2025.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 20776-2:2007.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard : 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 the
United Kingdom.
Endorsement notice
The text of ISO 20776-2:2021 has been approved by CEN as EN ISO 20776-2:2022 without any
modification.
INTERNATIONAL ISO
STANDARD 20776-2
Second edition
2021-12
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
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
Reference number
ISO 20776-2:2021(E)
ISO 20776-2:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 20776-2:2021(E)
Contents Page
Foreword .iv
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Test methods . 5
4.1 General . 5
4.2 Methods . 5
4.2.1 Reference method . . 5
4.2.2 Strain selection . 5
4.2.3 Quality control (QC) . 6
4.2.4 Quality control (QC) of the reference method . 6
4.2.5 Reproducibility testing of test device . 6
4.2.6 Isolate testing protocol . 7
4.2.7 Inoculum preparation . 7
4.2.8 Discrepancy resolution testing . 7
4.2.9 System under evaluation . 7
5 Data analysis and acceptance criteria . 8
5.1 Accuracy of test device . 8
5.1.1 General . 8
5.1.2 MIC devices . 8
5.1.3 Qualitative AST devices . 8
5.2 Quality control (QC) of test device . 8
5.3 Reproducibility of test device . 8
5.4 Documents related to study . 8
Annex A (informative) Evaluating the performance of MIC tests . 9
Annex B (informative) Rationale for bias analysis .12
Annex C (informative) Sensitivity and specificity analyses for qualitative tests .14
Bibliography .16
iii
ISO 20776-2:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/direc
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