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Norm
ÖNORM EN ISO 16256
Issue date: 2013 04 01
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)
This International Standard describes a method for testing the susceptibility to antifungal agents of
yeasts, including Candida spp. and Cryptococcus neoformans, that ca...
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Withdrawn
: 2022 02 15
Publisher:
Austrian Standards International
Format:
Digital | 24 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
This International Standard 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. Moreover, testing filamentous fungi (moulds) introduces
several additional problems in standardization not addressed by the current procedure. Reference
methods for broth dilution antifungal susceptibility testing of filamentous fungi have been developed
and are now available as CLSI document M38 and EUCAST document E.DEF 9.1[4][5][6][7][8].
This International Standard describes the broth microdilution reference method which can be
implemented by either of two pathways. One pathway involves visual determination of MICs (CLSI method)
[1]; the second pathway involves spectrophotometric determination of MICs (EUCAST method)[2]. The
MIC reflects the activity of the drug under the described test conditions and can be interpreted for clinical
management purposes by taking into account other factors, such as drug pharmacology or antifungal
resistance mechanisms. MICs can be categorized as ´´susceptible´´ (S), ´´susceptible dose-dependent´´ (SDD),
´´intermediate´´ (I), ´´non-susceptible´´ (NS) or ´´resistant´´ (R). In addition, MIC distributions can be
used to define wild type or non-wild type fungal populations. Clinical interpretation of the MIC value is
beyond the scope of this International Standard; interpretive category breakpoints specific to the CLSIand
EUCAST-derived methods can be found by consulting the latest interpretive tables provided by the
organizations[2][9]. It is advisable to compare routine susceptibility testing methods or diagnostic test
devices with this reference method in order to ensure comparable and reliable results for validation or
registration purposes.
ÖNORM EN ISO 16256
2022 02 15
Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference me...
Norm
ÖNORM EN ISO 16256
2013 04 01
Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the ...
Norm
↖
Norm
ÖNORM EN ISO 16256
Issue date :
2022 02 15
Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases (ISO 16256:2021)
Norm
ISO 16256:2012
Issue date :
2012 12 06
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