GB/T 40672-2021 English PDF

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GB/T 40672-2021: Clinical laboratory testing - Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 40672-2021	434	Add to Cart	4 days	Clinical laboratory testing - Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing	Valid

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Basic data

Standard ID: GB/T 40672-2021 (GB/T40672-2021)
Description (Translated English): Clinical laboratory testing - Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C44
Word Count Estimation: 25,263
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB/T 40672-2021: Clinical laboratory testing - Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Clinical laboratory testing - Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing ICS 11.100 CCSC44 National Standards of People's Republic of China Clinical laboratory test Antimicrobial sensitivity test dehydrated MH agar and broth Acceptable batch standard (ISO /T S16782.2016, IDT) Released on 2021-10-11 2023-05-01 implementation State Administration for Market Regulation Issued by the National Standardization Management Committee

Table of contents

Foreword Ⅲ Introduction Ⅳ 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Requirements for MH broth 3 4.1 Ingredients of MH broth 3 4.2 Physical and chemical properties 3 4.3 Manufacturer's test plan for dehydrated MH broth production batch 4 4.4 Interpretation of results 5 4.5 Evaluation of results 5 5 Requirements for MH agar 6 5.1 Composition of MH agar 6 5.2 Physical and chemical properties 6 5.3 Manufacturer's test plan for dehydrated MH agar production batch 7 5.4 Interpretation of results 7 5.5 Evaluation of results 9 6 Test the new antibacterial agent with dehydrated MH broth or agar production batch 9 Appendix A (informative) MH medium 10 Appendix B (Informative) Preparation of Quality Control Strains 12 Appendix C (informative) Recommended production batch test data sheet 14 Appendix D (Informative) Label Statement 18 Reference 19

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents" Drafting. This document is equivalent to using ISO /T S16782.2016 "Clinical laboratory test antimicrobial agent sensitivity test dehydrated MH agar and broth can be Acceptance of batch standards. Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying patents. This document was proposed by the State Drug Administration. This document is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136). Drafting organizations of this document. Beijing Medical Device Inspection Institute, Chongqing Medical Device Quality Inspection Center, Shandong Medical Device Product Quality Inspection center. The main drafters of this document. Bi Chunlei, He Lechun, Wang Wenqing, Dai Leiying, Li Chengzhi.

Introduction

Historically, although various media have been recommended for antimicrobial sensitivity tests, MH broth (MHB) was selected as the broth micro-dilution The minimum inhibitory concentration (MIC) reference method (ISO 20776-1) is the medium, and MH agar (MHA) is widely used for rapid growth of cells. The paper disc diffusion test of bacteria. MH medium can provide satisfactory growth conditions for most non-fastidious pathogens, with acceptable batch-to-batch reproducibility and low content Inhibitors of sulfa, trimethoprim and tetracycline, and a large number of antimicrobial agent sensitivity tests have accumulated from this medium for decades data. This document aims to establish a standard description and protocol, based on which dehydrated MH agar (dMHA) and dehydrated MH broth (dMHB) are prepared The manufacturer can determine its acceptable performance characteristics. The test results must meet the quality control limit range specified for each combination of antimicrobial agents and quality control strains. Each production batch should at least deal with this Combinations of these antibacterial agents and quality control strains were tested. This document is based in part on the previous two documents of the Clinical and Laboratory Standards Institute (CLSI) under license. CLSI M6-A2[1] (Dehydrated MH agar evaluation program) and CLSIM32-P[2] (Batch evaluation of dehydrated MH broth for antimicrobial susceptibility test). manufacture Traders can use this document to evaluate the performance characteristics of their dehydrated MH agar (dMHA) and dehydrated MH broth (dMHB) production batches. Clinical laboratory test Antimicrobial sensitivity test dehydrated MH agar and broth Acceptable batch standard

1 Scope

This document gives the standard description and performance standards of the physical properties of dehydrated MH broth (dMHB) and dehydrated MH agar (dMHA). In this way, manufacturers can evaluate the performance characteristics of their dMHB and dMHA production batches. Batches of broth or agar can then be used by all users (Including the manufacturer of in vitro susceptibility testing equipment) as a medium for conducting antimicrobial susceptibility testing. This document does not describe additives (such as blood or blood products) that are added to the culture medium to support the growth of fastidious bacteria (CLSI method Method)[3][4][5][6]. These additives are added as a final product when the dehydrated medium is prepared as a liquid, which is beyond the scope of this document. Although dMHA can be used for the agar dilution method[4][6] or gradient diffusion method to determine MIC. This document only contains in accordance with the American Association for Clinical and Laboratory Standards (CLSI) [5] and European Committee for Antimicrobial Susceptibility Testing (EUCAST) [3] performance test using the paper diffusion method.

2 Normative references

The content of the following documents constitutes an indispensable clause of this document through normative references in the text. Among them, dated quotations Only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to This document. YY/T 0688.1-2008 Clinical laboratory testing and in vitro diagnostic system infection pathogen susceptibility test and antimicrobial susceptibility Performance evaluation of test equipment. Part 1.Reference for the in vitro activity detection of antibacterial agents for rapid-growing aerobic bacteria related to infectious diseases Method (ISO 20776-1.2006, MOD) Note. There is no technical difference between the quoted content of YY/T 0688.1-2008 and the quoted content of ISO 20776-1.2006. ISO 20776-1 Infectious pathogen susceptibility test and performance evaluation of antibacterial agent susceptibility test equipment Part 1.Antibacterial agent pair The broth microdilution reference method for the in vitro activity detection of rapidly growing aerobic bacteria related to infectious diseases (Susceptibility testing of infectiousagentsandevaluationofperformanceofantimicrobialsusceptibilitytestdevices-Part 1. Brothmicro-dilutionreferencemethodfortestingtheinvitroactivityofantimicrobialagentsagainst rapidlygrowingaerobicbacteriainvolvedininfectiousdiseases) CLSIM100 Antimicrobial Agent Sensitivity Test Implementation Standard; Informational Supplement (Performance Standards for Antimicrobial SusceptibilityTesting;InformationalSupplement)

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Antimicrobial agent A general term for biologically derived, synthetic or semi-synthetic substances that can inhibit or kill microorganisms and may be used for anti-infective treatment. Note. Disinfectants, sterilants and preservatives are not within the scope of this definition. [Source. YY/T 0688.1-2008,2.1] ......

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