AS ISO 20776.2-2024 临床实验室检测和体外诊断检测系统 传染性病原体敏感性检测和抗菌药物敏感性检测设备性能评估 第2部分：抗菌药物敏感性检测设备性能评估

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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
Part 2: Evaluation of performance of antimicrobial susceptibility test
devices against reference broth micro-dilution
AS ISO 20776.2:2024
ISO 20776-2:2021
ISBN 978 1 76139 811 7
AS ISO 20776.2:2024
This Australian Standard® was prepared by HE-029, Clinical Laboratory Testing and
In Vitro Diagnostic Test Systems. It was approved on behalf of Standards Australia’s
Standards Development and Accreditation Committee on 03 August 2024.
This Standard was published on 13 September 2024.
The following are represented on Committee HE-029:
Australasian Association for Clinical Biochemistry and Laboratory Medicine
Australian Institute of Medical and Clinical Scientists
Australian Society for Microbiology
Human Genetics Society of Australasia
IVD Australia
Medical Technology Association of Australia
National Association of Testing Authorities Australia
National Pathology Accreditation Advisory Council
Pathology Australia
Public Pathology Australia
Royal College of Pathologists of Australasia
Therapeutic Goods Administration
This Standard was issued in draft form for comment as DR AS ISO 20776.2:2024.
Keeping Standards up-to-date
Ensure you have the latest versions of our publications and keep up-to-date about
Amendments, Rulings, Withdrawals, and new projects by visiting:
www.standards.org.au
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 against
reference broth micro-dilution
AS ISO 20776.2:2024
ISO 20776-2:2021
COPYRIGHT
© ISO 2024 — All rights reserved
© Standards Australia Limited 2024
All rights are reserved. No part of this work may be reproduced or copied in any
form or by any means, electronic or mechanical, including photocopying, without the
written permission of the publisher, unless otherwise permitted under the Copyright
Act 1968 (Cth).
Originated as AS ISO 20776.2:2017.
Second edition 2024.

标签： #ISO #敏感性 #实验室

摘要：

本页面提供AS ISO 20776.2-2024标准的完整解读与说明。该标准全称为《临床实验室检测和体外诊断检测系统 传染性病原体敏感性检测和抗菌药物敏感性检测设备性能评估 第2部分：抗菌药物敏感性检测设备性能评估》，是国际标准化组织（ISO）针对临床实验室及体外诊断领域的重要技术规范。标准主要规定了抗菌药物敏感性检测设备（如自动化药敏系统、MIC测定仪器等）的性能评估方法，覆盖准确性、重复性、再现性及与参考方法的符合性等关键指标。适用于医疗机构、检验实验室、体外诊断设备制造商及质量监管机构参考

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AS ISO 20776.2-2024 临床实验室检测和体外诊断检测系统 传染性病原体敏感性检测和抗菌药物敏感性检测设备性能评估 第2部分：抗菌药物敏感性检测设备性能评估.pdf

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作者：标准小能手 分类：国际标准 价格：16星币 属性：26 页 大小：1.74MB 格式：PDF 时间：2025-08-05

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