EN ISO 16256:2012
(Main)Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases (ISO 16256:2012)
Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases (ISO 16256:2012)
ISO 16256:2012 describes a method for testing the susceptibility to antifungal agents of yeasts, including Candida spp. and Cryptococcus neoformans, that cause infections. The reference method described here has not been used in studies of the yeast forms of dimorphic fungi, such as B. dermatitidis and/or H. capsulatum variety capsulatum.
ISO 16256:2012 describes the broth microdilution reference method which can be implemented by either of two pathways. One pathway involves visual determination of MICs (CLSI method); the second pathway involves spectrophotometric determination of MICs (EUCAST method).
Labormedizinische Untersuchungen und In-vitro-Diagnostika-Systeme - Referenzmethode zur Testung der In-vitro-Aktivität von antimikrobiellen Substanzen gegen Pilze, die Infektionskrankheiten verursachen (ISO 16256:2012)
Diese Internationale Norm beschreibt eine Methode zur Empfindlichkeitsprüfung von Sprosspilzen gegen Antimykotika, einschließlich Candida spp. und Cryptococcus neoformans, die Infektionen verursachen. Das hier beschriebene Referenzverfahren wurde nicht bei Untersuchungen der Hefeformen dimorpher Pilze, wie z. B. B. dermatitidis und/oder H. capsulatum Varietät capsulatum angewendet. Außerdem führt die Prüfung von fadenförmigen Pilzen (Schimmelpilzen) zu verschiedenen zusätzlichen Problemen hinsichtlich der Standardisierung, die in dem vorliegenden Verfahren nicht behandelt werden. Referenzmethoden für die antimykotische Empfindlichkeitsprüfung von fadenförmigen Pilzen mit Bouillondilution wurden entwickelt und stehen derzeit als CLSI Dokument M38 und EUCAST Dokument E.DEF 9.1 zur Verfügung [4][5][6][7][8].
Diese Internationale Norm beschreibt die Referenzmethode der Bouillonmikrodilution, die auf eine von zwei Weisen umgesetzt werden kann. Eine Weise umfasst die visuelle Bestimmung von MHK (CLSI Methode) [1]; die Zweite die spektrophotometrische Bestimmung von MHK (EUCAST Methode) [2]. Die MHK widerspiegelt die Aktivität des Wirkstoffs unter den beschriebenen Prüfbedingungen und kann unter Berücksichtigung anderer Faktoren, wie z. B. der Pharmakologie des Wirkstoffs oder antimykotischer Resistenzmechanismen, zur Interpretation für klinische Zwecke angewendet werden. MHK können als sensibel (S), dosisabhängig sensibel (S DD), intermediär (I), nicht sensibel (NS) oder resistent (R) eingestuft werden. Die Verteilung der MHK Werte kann zudem dazu dienen, Wildtyp Pilzpopulationen von Nicht Wildtyp Pilzpopulationen zu unterscheiden. Die klinische Interpretation der MHK Werte fällt nicht in den Anwendungsbereich dieser Internationalen Norm; erläuternde Grenzwerte für die Kategorien, die für die von CLSI und EUCAST abgeleiteten Methoden spezifisch sind, können durch Hinzuziehen der von den Organisationen bereitgestellten aktuellen erläuternden Tabellen [2][9] ermittelt werden. Es ist ratsam, die Routinemethoden oder Diagnosegeräte zur Empfindlichkeitsprüfung mit dieser Referenzmethode zu vergleichen, um vergleichbare und zuverlässige Ergebnisse für Validierungs oder Registrierungszwecke sicherzustellen.
WARNUNG Die Anwendung dieser Internationalen Norm kann mit der Anwendung gefährlicher Stoffe, Verfahrensschritte und Ausrüstungsgegenstände verbunden sein. Diese Internationale Norm erhebt nicht den Anspruch, dass alle mit ihrer Anwendung verbundenen Sicherheitsprobleme angesprochen werden. Es liegt in der Verantwortung des Anwenders von ISO 16256, geeignete Vorkehrungen für den Arbeits und Gesundheitsschutz zu treffen und vor der Anwendung die Anwendbarkeit einschränkender Vorschriften zu bestimmen.
Essais de laboratoire clinique et systèmes de diagnostic in vitro - Méthode de référence pour soumettre à essai l'activité in vitro des agents antimicrobiens par rapport aux levures impliquées dans les maladies infectieuses (ISO 16256:2012)
L'ISO 16256:2012 décrit une méthode d'essai de la sensibilité aux agents antifongiques des levures pathogènes, dont Candida spp. et Cryptococcus neoformans. La méthode de référence ici décrite n'a pas été utilisée dans des études sur les phases levures de champignons dimorphes tels que B. dermatitidis et ou H. capsulatum variété capsulatum.
L'ISO 16256:2012 décrit la méthode de référence pour la microdilution en milieu liquide qui peut être réalisée de deux façons. La première implique une détermination visuelle de la CMI (méthode CLSI); la seconde implique une détermination spectrophotométrique de la CMI (méthode EUCAST).
Klinično laboratorijsko preskušanje ter dignostični preskusni sistemi in vitro - Referenčna metoda za preskušanje aktivnosti in vitro antimikrobnih snovi proti gobam kvasovkam, ki povzročajo infekcijske bolezni (ISO 16256:2012)
Ta mednarodni standard opisuje metodo za preskušanje dovzetnosti kvasovk, vključno s Candida spp. in Cryptococcus neoformans, ki povzročajo infekcije, za antimikotične snovi. Tukaj opisana referenčna metoda se ne uporablja pri študijah oblik kvasovk dimorfnih gliv, npr. B. dermatitidis in/ali H. capsulatum. Poleg tega preskušanje filamentoznih gliv (plesni) predstavlja številne dodatne težave za standardizacijo, ki jih trenutni postopek ne zajema. Razvite so bile referenčne metode za preskušanje antimikotične dovzetnosti filamentoznih gliv z dilucijsko metodo v bujonu, ki so zdaj na voljo kot CLSI dokument M38 in EUCAST dokument E.DEF 9.1. Ta del standarda ISO 16256 opisuje mikrodilucijsko referenčno metodo v bujonu, ki se lahko izvede z dvema postopkoma. En postopek zajema vizualno določanje vrednosti MIK (metoda CLSI), drug postopek pa zajema spektrofotometrijsko določanje vrednosti MIK (metoda EUCAST). Vrednost MIK kaže aktivnost zdravila v predpisanih preskusnih pogojih in se lahko razlaga za namene kliničnega upravljanja z upoštevanjem drugih dejavnikov, na primer farmakologije zdravila ali mehanizmov antimikotične odpornosti. Vrednosti MIK se lahko kategorizirajo kot »dovzetno« (S), »dovzetno odvisno od odmerka« (S-DD), »srednje« (I), »nedovzetno« (NS) ali »odporno« (R). Poleg tega se lahko razporeditve MIK uporabljajo za določanje divjega tipa ali nedivjega tipa glivične populacije. Klinična razlaga vrednosti MIK ne spada na področje uporabe tega dela standarda ISO 16256; interpretativne kategorične mejne vrednosti, značilne za metode, izpeljane iz CLSI in EUCAST, so navedene v najnovejših interpretativnih tabelah, ki jih predložijo organizacije. Priporočljivo je, da se rutinske metode za preskušanje dovzetnosti ali diagnostične preskusne naprave primerjajo s to referenčno metodo, da se zagotovijo primerljivi in zanesljivi rezultati za validacijo ali registracijo.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2013
.OLQLþQRODERUDWRULMVNRSUHVNXãDQMHWHUGLJQRVWLþQLSUHVNXVQLVLVWHPLLQYLWUR
5HIHUHQþQDPHWRGD]DSUHVNXãDQMHDNWLYQRVWLLQYLWURDQWLPLNUREQLKVQRYLSURWL
JREDPNYDVRYNDPNLSRY]URþDMRLQIHNFLMVNHEROH]QL ,62
Clinical laboratory testing and in vitro diagnostic test systems - Reference method for
testing the in vitro activity of antimicrobial agents against yeast of fungi involved in
infectious diseases (ISO 16256:2012)
Labormedizinische Untersuchungen und In-vitro-Diagnostika-Systeme -
Referenzmethode zur Testung der In-vitro-Aktivität von antimikrobiellen Substanzen
gegen Pilze, die Infektionskrankheiten verursachen (ISO 16256:2012)
Essais de laboratoire clinique et systèmes de diagnostic in vitro - Méthode de référence
pour soumettre à essai l'activité in vitro des agents antimicrobiens par rapport aux
levures impliquées dans les maladies infectieuses (ISO 16256:2012)
Ta slovenski standard je istoveten z: EN ISO 16256:2012
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 16256
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2012
ICS 11.100.10
English Version
Clinical laboratory testing and in vitro diagnostic test systems -
Reference method for testing the in vitro activity of antimicrobial
agents against yeast of fungi involved in infectious diseases
(ISO 16256:2012)
Essais de laboratoire clinique et systèmes de diagnostic in Labormedizinische Untersuchungen und In-vitro-
vitro - Méthode de référence pour soumettre à essai Diagnostika-Systeme - Referenzmethode zur Testung der
l'activité in vitro des agents antimicrobiens par rapport aux In-vitro-Aktivität von antimikrobiellen Substanzen gegen
levures impliquées dans les maladies infectieuses (ISO Pilze, die Infektionskrankheiten verursachen (ISO
16256:2012) 16256:2012)
This European Standard was approved by CEN on 30 November 2012.
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
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© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16256:2012: E
worldwide for CEN national Members.
Contents Page
Foreword . 3
Foreword
This document (EN ISO 16256:2012) 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 June 2013, and conflicting national standards shall be withdrawn at
the latest by December 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 16256:2012 has been approved by CEN as a EN ISO 16256:2012 without any modification.
INTERNATIONAL ISO
STANDARD 16256
First edition
2012-12-01
Clinical laboratory testing and in vitro
diagnostic test systems — Reference
method for testing the in vitro activity
of antimicrobial agents against yeast
fungi involved in infectious diseases
Essais de laboratoire clinique et systèmes de diagnostic in vitro —
Méthode de référence pour soumettre à essai l’activité in vitro des
agents antimicrobiens par rapport aux levures impliquées dans les
maladies infectieuses
Reference number
ISO 16256:2012(E)
©
ISO 2012
ISO 16256:2012(E)
© ISO 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any
means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the
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ii © ISO 2012 – All rights reserved
ISO 16256:2012(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Terms and definitions . 1
3 Test procedures . 4
3.1 General . 4
3.2 Medium . 4
3.3 Antifungal agents . 5
3.4 Storage of microdilution trays . 7
3.5 Preparation of inoculum — General . 8
3.6 Inoculation of microdilution trays . 8
3.7 Incubation of microdilution trays . 9
3.8 Reading MIC results . 9
3.9 Interpretation of MICs .10
4 Quality control (QC) .10
Annex A (informative) RPMI-1640 medium .13
Annex B (informative) McFarland 0,5 barium sulfate turbidity standard .15
Annex C (informative) Acceptable reading times for MIC interpretations using the visual MIC
reading procedure .16
Bibliography .17
ISO 16256:2012(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 16256 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro
diagnostic test systems.
iv © ISO 2012 – All rights reserved
ISO 16256:2012(E)
Introduction
In vitro susceptibility tests are performed on microorganisms suspected of causing disease, particularly
if the organism is thought to belong to a species that may exhibit acquired resistance to frequently used
antimicrobial agents. The tests are also important in resistance surveillance, epidemiological studies of
susceptibility and in comparisons of new and existing agents.
Dilution procedures are used to determine the minimum inhibitory concentrations (MICs) of antimicrobial
agents and represent the reference method for antifungal susceptibility testing. MIC methods are used
in resistance surveillance, comparative testing of new agents for research or registration purposes,
to establish the susceptibility of organisms that give equivocal results in routine tests, for tests with
organisms where routine tests may be unreliable and when a quantitative result is needed for clinical
management. In dilution tests, microorganisms are tested for their ability to produce discernible growth
on a series of agar plates (agar dilution) or in broth (broth dilution) containing serial dilutions of the
antimicrobial agent.
The lowest concentration of an antimicrobial agent (in mg/l) that, under defined in vitro test conditions,
reduces visible or optically measurable growth of a microorganism within a defined period of time
is known as the MIC. The MIC is a guide for the clinician to the susceptibility of the organism to the
antimicrobial agent and aids treatment decisions. Careful control and standardization is required
for intra- and inter-laboratory reproducibility, as results may be influenced by the method used. It is
generally accepted that broth MIC tests are reproducible to within one doubling dilution of the true end
point (i.e. ±1 well or tube in a doubling dilution series).
Broth dilution is a technique in which containers holding identical volumes of broth with antimicrobial
agent solutions in incrementally (usually twofold) increasing concentrations are inoculated with a
known number of microorganisms.
Broth microdilution denotes the performance of the broth dilution test in microdilution trays.
The reference methods described in this International Standard are intended for the testing of pure
cultures of yeast fungi. The broth microdilution methods described in this part of this International
Standard are essentially
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