ISO 20776-2:2021 臨床検査およびinvitro診断試験システム—感染性薬剤の感受性試験および抗菌薬感受性試験装置の性能の評価—パート2：参照ブロス微量希釈に対する抗菌薬感受性試験装置の性能の評価 | ページ 2

Foreword

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The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives ).

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This document was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 140, In vitro diagnostic medical devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This second edition cancels and replaces the first edition (ISO 20776-2:2007), which has been technically revised.

The main changes are as follows:

• Revision in the title of this document to better align with the intended information.
• Addition of an Introduction (not present in the first edition).
• Revised Clause 3 as follows:
  • Removed definitions for category agreement, susceptible, intermediate, resistant, non-susceptible, major discrepancy, minor discrepancy, very major discrepancy, breakpoint test and zone diameter;
  • Added definition for contemporary isolate (3.11.1), and removed definitions for fresh isolate, recent isolate;
  • Added definitions for reproducibility (3.9), bias of the test method (3.10.3), sensitivity analysis (3.10.4.1), specificity analysis (3.10.4.2), bacterial organism group (3.16);
  • Added definition for qualitative test (3.7) and removed definition for breakpoint test;
  • Revised definitions for minimum inhibitory concentration test (3.4), breakpoint (3.6), quality control (3.8), discrepancy (3.10.1).

• Reordered Clause 4 (Test methods);

• Moved general requirements for a performance evaluation as a separate section, to the overview (now renamed general section, subclause 4.1) under test methods);

• Revised quality control section, subclause 4.2, and referenced EUCAST and CLSI documents for quality control ranges;

• Revised subclause 4.2.1 (Reference method) to add variability;

• Revised subclause 4.2.2 (Strain selection) and incorporated new definition of contemporary isolates (3.11.1);

• Revised subclause 4.2.5 (Reproducibility testing);

• Updated subclause 4.2.8 (Discrepancy resolution testing);

• Combined data analysis and acceptance criteria subclauses (Clause 5);

• Revised subclause 5.1 (Accuracy of test device) to remove category agreement;

• Revised data analysis for MIC devices to remove category agreement. Added bias requirement;

• Removed acceptance for breakpoint AST devices;

• Added provisions on acceptance criteria for qualitative AST devices (5.1.3) and included sensitivity and specificity requirements;

• Revised subclauses on quality control of test device and reproducibility of test device (5.2 and 5.3);

• Revised Bibliography;

• Added Annex A — Evaluation the Performance of MIC Tests, Annex B — Rationale for Bias Analysis, and Annex C — Sensitivity and Specificity Analyses for Qualitative Tests.