BS EN ISO 20776-2:2021:2022 Edition

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Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices – Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution

Published By	Publication Date	Number of Pages
BSI	2022	26

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Categories: 11.100.20 - Biological evaluation of medical devices, BSI

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Description

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PDF Pages	PDF Title
2	National foreword
4	European foreword
6	Foreword
8	Introduction
9	1 Scope 2 Normative references 3 Terms and definitions
11	3.10 Terms relating to the evaluation of test results 3.10.4 Terms relating to sensitivity analysis
12	3.11 Terms relating to bacterial isolates
13	4 Test methods 4.1 General 4.2 Methods 4.2.1 Reference method 4.2.2 Strain selection
14	4.2.3 Quality control (QC) 4.2.4 Quality control (QC) of the reference method 4.2.5 Reproducibility testing of test device
15	4.2.6 Isolate testing protocol 4.2.7 Inoculum preparation 4.2.8 Discrepancy resolution testing 4.2.9 System under evaluation
16	5 Data analysis and acceptance criteria 5.1 Accuracy of test device 5.1.1 General 5.1.2 MIC devices 5.1.3 Qualitative AST devices 5.2 Quality control (QC) of test device 5.3 Reproducibility of test device 5.4 Documents related to study
17	Annex A (informative) Evaluating the performance of MIC tests
20	Annex B (informative) Rationale for bias analysis
22	Annex C (informative) Sensitivity and specificity analyses for qualitative tests
24	Bibliography

Additional information

Status	Definitive
Pages	26
Publication Date	2022-01-21
ISBN	978 0 539 15112 1
Standard Number	BS EN ISO 20776-2:2021
Title	Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices – Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution
Identical National Standard Of	EN ISO 20776-2, ISO 20776-2
Replaces	BS EN ISO 20776-2:2007
Descriptors	Testing conditions, Performance testing, Clinical medicine, Diagnosis (medical), Microorganisms, Clinical testing, Laboratory testing, Biological analysis and testing, Bacteria, Pathogens, Biological hazards, Drugs, Antibiotics
Publisher	BSI
Committee	CH/212
ICS Codes	11.100.20 - Biological evaluation of medical devices

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BS EN ISO 20776-2:2021:2022 Edition

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