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)
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)
This standard establishes acceptable performance criteria for antimicrobial susceptibility test (AST) devices that are used for determining minimal inhibitory concentrations (MIC) and/or interpretive category determinations (Susceptible, Intermediate, Resistant, SIR) of bacteria to antimicrobial agents in medical laboratories. This standard 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 should be conducted. This standard has been developed to guide manufacturers in the conduct of performance evaluation studies.
Empfindlickeitsprüfung von Infektionserregern und Evalution von Geräten zur antimikrobiellen Empfindlichkeitsprüfung - Teil 2: Evalution von Geräten zur antimikrobiellen (ISO 20776-2:2007)
Die vorliegende Norm legt annehmbare Leistungskriterien für Einrichtungen zur Prüfung der mikrobiellen
Empfindlichkeit (AST) fest, die zur Bestimmung der minimalen Hemmkonzentrationen (MHK) und/oder
interpretierender Kategoriebestimmungen (Sensibel, Intermediär, Resistent, SIR) von Bakterien auf
mikrobielle Wirkstoffe in medizinischen Laboren verwendet werden. Diese Norm legt Anforderungen an
Einrichtungen zur Prüfung der mikrobiellen Empfindlichkeit (AST) (einschließlich Diffusionstestsysteme) sowie
Verfahren zur Leistungsbewertung dieser Einrichtungen fest. Es wird definiert, wie eine Leistungsbewertung
einer Einrichtung zur Prüfung der mikrobiellen Empfindlichkeit (AST) durchgeführt werden sollte. Die
vorliegende Norm wurde mit dem Ziel erarbeitet, Hersteller bei der Durchführung von Leistungsbewertungsstudien
anzuleiten.
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)
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
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 20776-2:2008
01-julij-2008
.OLQLþQLODERUDWRULMVNLSUHVNXVLWHUGLDJQRVWLþQLSUHVNXVQLVLVWHPLLQYLWUR
3UHVNXVREþXWOMLYRVWLSRY]URþLWHOMHYLQIHNFLMLQYUHGQRWHQMHGHORYDQMDDQWLPLNUREQR
REþXWOMLYLKSUHVNXVQLKQDSUDYGHO 9UHGQRWHQMHGHORYDQMDDQWLPLNUREQR
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 edition
2007-07-01
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
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
Reference number
ISO 20776-2:2007(E)
©
ISO 2007
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ISO 20776-2:2007(E)
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ii © ISO 2007 – All rights reserved
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ISO 20776-2:2007(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 20776-2 was prepared by the European Committee for Standardization (CEN) Technical Committee
CEN/TC 140, In vitro diagnostic medical devices, in collaboration with Technical Committee ISO/TC 212,
Clinical laboratory testing and in vitro diagnostic test systems, in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement).
ISO 20776 consists of the following parts, under the general title Clinical laboratory testing and in vitro
diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of
antimicrobial susceptibility test devices:
⎯ Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing
aerobic bacteria involved in infectious diseases
⎯ Part 2: Evaluation of performance of antimicrobial susceptibility test devices
© ISO 2007 – All rights reserved iii
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INTERNATIONAL STANDARD ISO 20776-2:2007(E)
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
1 Scope
This part of ISO 20776 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. This part of ISO 20776 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. This part of ISO 20776 has been developed to guide manufacturers in
the conduct of performance evaluation studies.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 20776-1, Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of
infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 1:
Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic
bacteria involved in infectious diseases
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 Agreement of test results
3.1.1
category agreement
CA
agreement of SIR results between a breakpoint test or an MIC test and the reference method (ISO 20776-1)
Another representation of the concept:
N ×100
CA
N
© ISO 2007 – All rights reserved 1
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ISO 20776-2:2007(E)
where
N is the number of bacterial isolates with the same SIR category as the reference method category
CA
result;
N is the total number of bacterial isolates tested
NOTE The overall CA is expressed as a percentage.
3.1.2
essential agreement
EA
MIC result obtained with the AST device that is within plus or minus one doubling dilution step from the MIC
value established with the reference method (ISO 20776-1)
Another representation of the concept:
N ×100
EA
N
where
N is the number of bacterial isolates with an EA;
EA
N is the total number of bacterial isolates tested
NOTE The overall EA is expressed as a percentage.
3.2
antimicrobial susceptibility test device
AST device
device including all specified components used to obtain test results that allow SIR categorization of bacteria
with specific antimicrobial agents
NOTE Specific components include inoculators, disposables and reagents, media, disks and readers. Non-specific
components, such as swabs, pipettes and tubes, are not part of the device.
3.3
breakpoint
BP
specific values of parameters, such as MICs, on the basis of which bacteria can be assigned to the clinical
categories “susceptible”, “intermediate” and “resistant”
NOTE For current interpretive breakpoints, reference can be made to the latest publications of organizations
employing this reference method (e.g. CLSI and EUCAST).
3.3.1
susceptible
S
bacterial strain inhibited in vitro by a concentration of an antimicrobial agent that is associated with a high
likelihood of therapeutic success
NOTE 1 Bacterial strains are categorized as susceptible by applying the appropriate breakpoints in a defined
phenotypic test system.
NOTE 2 This breakpoint can be altered due to changes in circumstances (e.g. changes in commonly used drug
dosages, emergence of new resistance mechanisms).
2 © ISO 2007 – All rights reserved
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ISO 20776-2:2007(E)
3.3.2
intermediate
I
bacterial strain inhibited in vitro by a concentration of an antimicrobial agent that is associated with uncertain
therapeutic effect
NOTE 1 Bacterial strains are categorized as intermediate by applying the appropriate breakpoints in a defined
phenotypic test system.
NOTE 2 This class of susceptibility implies that an infection due to the isolate can be appropriately treated in body sites
where the drugs are physiologically concentrated or when a high dosage of drug can be used.
NOTE 3 This class also indicates a “buffer zone”, to prevent small, uncontrolled, technical factors from causing major
discrepancies in interpretations.
NOTE 4 These breakpoints can be altered due to changes in circumstances (e.g. changes in commonly used drug
dosages, emergence of new resistance mechanisms).
3.3.3
resistant
R
bacterial strain inhibited in vitro by a concentration of an antimicrobial agent that is associated with a high
likelihood of therapeutic failure
NOTE 1 Bacterial strains are categorized as resistant by applying the appropriate breakpoints in a defined phenotypic
test system.
NOTE 2 This breakpoint can be altered due to changes in circumstances (e.g. changes in commonly used drug
dosages, emergence of new resistance mechanisms).
3.3.4
non-susceptible
NS
bacterial strain for which the test result exceeds the suscep
...
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