DIN EN ISO 20776-2:2007-09
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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)
Hardcopy , PDF
03-28-2022
English, German
09-01-2007
Vorwort
1 Anwendungsbereich
2 Normative Verweisungen
3 Begriffe
4 Allgemeine Anforderungen für eine Leistungsbewertung
5 Prüfverfahren
5.1 Überblick
5.2 Verfahren
5.2.1 Stammauswahl
5.2.2 Prüfprotokoll
5.2.3 Herstellen des Inokulums
5.2.4 Überprüfung der Reproduzierbarkeit mit dem Testsystem
5.2.5 Qualitätskontrolle (en: quality control, QC) der
Referenzmethode
5.2.6 Ergebnisse
5.2.7 Überprüfung der Abweichungen
5.2.8 Zu prüfendes System
5.3 Datenauswertung
5.4 Annahmekriterien
5.4.1 Genauigkeit des Testsystems
5.4.2 Qualitätskontrolle des Testsystems
5.4.3 Reproduzierbarkeit des Testsystems
5.5 Studiendokumentation
Literaturhinweise
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