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DIN EN ISO 20776-2:2007-09

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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)

Available format(s)

Hardcopy , PDF

Superseded date

03-28-2022

Language(s)

English, German

Published date

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

This standard is included in DIN Handbook 222. 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.

DocumentType
Standard
Pages
13
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded
SupersededBy

DIN HDBK 222 : 3ED 2015 MEDIZINISCHE MIKROBIOLOGIE UND IMMUNOLOGIE - DIAGNOSTISCHE VERFAHREN

EN 13612:2002/AC:2002 PERFORMANCE EVALUATION OF IN VITRO DIAGNOSTIC MEDICAL DEVICES
ISO 20776-1:2006 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

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