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)

ISO 20776-2:2007 establishes acceptable performance criteria for antimicrobial susceptibility test (AST) devices that are used to determine minimum inhibitory concentrations (MIC) and/or interpretive category determinations of susceptible, intermediate and resistant (SIR) strains of bacteria to antimicrobial agents in medical laboratories. ISO 20776-2:2007 specifies requirements for AST devices (including diffusion test systems) and procedures for assessing performance of such devices. It defines how a performance evaluation of an AST device is to be conducted. ISO 20776-2:2007 has been developed to guide manufacturers in the conduct of performance evaluation studies.

Labormedizinische Untersuchungen und In-vitro-Diagnostika-Systeme - Empfindlickeitsprüfung von Infektionserregern und Evalution von Geräten zur antimikrobiellen Empfindlichkeitsprüfung - Teil 2: Evalution der Leistung einer Vorrichtung zur antimikrobiellen Empfindlichkeitsprüfung (ISO 20776-2:2007)

Dieser Teil der ISO 20776 legt annehmbare Leistungskriterien für Testsysteme zur Prüfung der mikrobiellen Empfindlichkeit fest, die zur Bestimmung der minimalen Hemmkonzentrationen (MHK) und/oder interpretierender Kategoriebestimmungen (Sensibel, Intermediär, Resistent, SIR) von Bakterien auf antimikrobielle Substanzen in medizinischen Laboren verwendet werden. Dieser Teil der ISO 20776 legt Anforderungen an Testsysteme zur Prüfung der mikrobiellen Empfindlichkeit (einschließlich Diffusionstestsysteme) sowie Verfahren zur Leistungsbewertung dieser Testsysteme fest. Es wird definiert, wie eine Leistungsbewertung eines Testsystems zur Prüfung der mikrobiellen Empfindlichkeit durchzuführen ist. Dieser Teil der ISO 20776 wurde mit dem Ziel erarbeitet, Hersteller bei der Durchführung von Leistungs¬bewertungsstudien 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 (ISO 20776-2:2007)

L'ISO 20776-2:2007 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) et/ou déterminer des catégories de bactéries sensibles, intermédiaires ou résistantes (SIR) dans des laboratoires médicaux. L'ISO 20776-2:2007 indique les exigences pour les dispositifs DMSA (incluant les systèmes de diffusion), ainsi que les modes opératoires permettant d'estimer la performance de ces dispositifs. Elle définit comment une évaluation des performances d'un dispositif DMSA doit être effectuée. L'ISO 20776-2:2007 a été développée 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 20776-2:2007)

General Information

• Status: Withdrawn
• Publication Date: 30-Jun-2007
• Withdrawal 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/WG 10 - Antimicrobial susceptibility testing
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 19-Jan-2022
• Ref Project: SIST EN ISO 20776-2:2008 - 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)

Relations

• Replaced By: 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)
• Effective Date: 26-Jan-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 20776-2:2008
01-julij-2008
.OLQLþQLODERUDWRULMVNLSUHVNXVLWHUGLDJQRVWLþQLSUHVNXVQLVLVWHPLLQYLWUR
3UHVNXVREþXWOMLYRVWLSRY]URþLWHOMHYLQIHNFLMLQYUHGQRWHQMHGHORYDQMDDQWLPLNUREQR
REþXWOMLYLKSUHVNXVQLKQDSUDYGHO9UHGQRWHQMHGHORYDQMDDQWLPLNUREQR
REþXWOMLYLKQDSUDY,62
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)
Empfindlickeitsprüfung von Infektionserregern und Evalution von Geräten zur
antimikrobiellen Empfindlichkeitsprüfung - Teil 2: Evalution von Geräten zur
antimikrobiellen (ISO 20776-2:2007)
Systemes d'essais en laboratoire et de diagnostic in vitro - Essais de susceptibilité
d'agents infectieux et évaluation des performances des dispositifs de susceptibilité
antimicrobienne - Partie 2: Évaluation des performances du dispositif de susceptibilité
antimicrobienne (ISO 20776-2:2007)
Ta slovenski standard je istoveten z: EN ISO 20776-2:2007
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
SIST EN ISO 20776-2:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 20776-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2007
ICS 11.100.20

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 (ISO 20776-2:2007)
Systèmes d'essais en laboratoire et de diagnostic in vitro - Labormedizinische Untersuchungen und In-vitro-
Sensibilité in vitro des agents infectieux et évaluation des Diagnostika-Systeme - Empfindlickeitsprüfung von
performances des dispositifs pour antibiogrammes - Partie Infektionserregern und Evalution von Geräten zur
2: Évaluation des performances des dispositifs pour antimikrobiellen Empfindlichkeitsprüfung - Teil 2: Evalution
antibiogrammes (ISO 20776-2:2007) der Leistung einer Vorrichtung zur antimikrobiellen
Empfindlichkeitsprüfung (ISO 20776-2:2007)
This European Standard was approved by CEN on 24 June 2007.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20776-2:2007: E
worldwide for CEN national Members.

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EN ISO 20776-2:2007 (E)





Foreword


This document (EN ISO 20776-2:2007) has been prepared by Technical Committee CEN/TC
140 "In vitro diagnostic medical devices", the secretariat of which is held by DIN, in collaboration
with Technical Committee ISO/TC 212 "Clinical laboratory testing and in vitro diagnostic test
systems".

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 January 2008, and conflicting national
standards shall be withdrawn at the latest by January 2008.

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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United
Kingdom.


2

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INTERNATIONAL ISO
STANDARD 20776-2
First e
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