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YY/T 0688.2-2024: 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 te
Status: Valid YY/T 0688.2: Evolution and historical versions
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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 te
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YY/T 0688.2-2024
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| YY/T 0688.2-2010 | English | 214 |
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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 devices. Part 2: Evaluation of performance of antimicrobial susceptibility test dev
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YY/T 0688.2-2010
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Basic data | Standard ID | YY/T 0688.2-2024 (YY/T0688.2-2024) | | Description (Translated English) | 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 te | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 22,228 | | Date of Issue | 2024-09-29 | | Date of Implementation | 2025-10-15 | | Older Standard (superseded by this standard) | YY/T 0688.2-2010 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the acceptable performance standards for antimicrobial susceptibility testing (AST) equipment. These equipment are used in medical laboratories to determine the minimum inhibitory concentration (MIC) of bacteria to antimicrobial drugs. This standard specifies the requirements for AST equipment and the procedures for evaluating the performance of these equipment. This standard provides how to conduct AST equipment performance evaluation. This standard is used to guide manufacturers in performance evaluation studies. | YY/T 0688.2-2024: 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 te
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ICS 11.100
CCSC44
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY/T 0688.2-2010
Clinical laboratory testing and in vitro diagnostics for systemic infectious diseases
Pathogen susceptibility testing and antimicrobial susceptibility
Performance evaluation of test equipment Part 2.Broth
Antimicrobial drugs compared with microdilution reference methods
Sensitivity test equipment performance evaluation
(ISO 20776-2.2021,IDT)
Published on September 29, 2024, implemented on October 15, 2025
The State Drug Administration issued
Table of Contents
Preface III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Test methods 4
4.1 Overview 4
4.2 Method 5
4.2.1 Reference method 5
4.2.2 Strain selection 5
4.2.3 Quality Control 5
4.2.4 Quality control of reference method 6
4.2.5 Reproducibility test of the equipment under test 6
4.2.6 Isolate test protocol 6
4.2.7 Inoculum preparation 6
4.2.8 Bias discrimination test 6
4.2.9 Evaluated system 7
5 Data Analysis and Acceptance Criteria 7
5.1 Accuracy of the equipment under test 7
5.1.1 General 7
5.1.2 MIC equipment 7
5.1.3 Qualitative AST equipment 7
5.2 Quality Control of Equipment Under Test 7
5.3 Reproducibility of the equipment under test 8
5.4 Research related documents 8
Appendix A (Informative) Evaluation of the performance of the MIC test 9
Appendix B (Informative) Basic Principles of Bias Analysis 11
Appendix C (Informative) Sensitivity and specificity analysis of qualitative tests 13
Reference 15
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 for standardization documents"
Drafting.
This document replaces YY/T 0688.2-2010 "Clinical laboratory testing and in vitro diagnostic systems for infectious pathogens sensitivity testing and antimicrobial resistance"
Performance evaluation of antimicrobial susceptibility test equipment Part 2.Performance evaluation of antimicrobial susceptibility test equipment"
Compared with.2010, in addition to structural adjustments and editorial changes, the main technical changes are as follows.
---Deleted "Classification compliance", "Sensitive", "Intermediate", "Resistant", "Non-sensitive", "Breakpoint test", "Major deviation", "Minor deviation", "Major deviation"
The terms and definitions of “breakpoint test”, “fresh isolate”, “recent isolate” and “inhibition zone diameter” (see the.2010 edition of
3.1.1, 3.3.1, 3.3.2, 3.3.3, 3.3.4, 3.4, 3.6.1, 3.6.2, 3.6.3, 3.4, 3.9.1, 3.9.2, 3.15);
--- Added "qualitative test", "reproducibility", "bias of the test method", "sensitivity analysis", "sensitivity analysis", "current isolates", "bacteria
The term and definition of "microbial biota" (see 3.7, 3.9, 3.10.3, 3.10.4.1, 3.10.4.2, 3.11.1, 3.16);
--- Changed the definitions of the terms "minimum inhibitory concentration test", "breakpoint", "quality control" and "bias" (see 3.4, 3.6, 3.8, 3.10.1,
2010 version 3.12, 3.3, 3.6);
--- Changed the order of the clauses of the test methods in Chapter 4 (see Chapter 4);
--- Changed the general requirements for performance evaluation (see 4.1, Chapter 4 of the.2010 edition);
--- Changed the quality control section and referred to the quality control scope of EUCAST and CLSI documents (see 4.2);
--- Changed the reference method part (see 4.2.1, 5.2.5 of the.2010 edition);
--- Changed the strain selection to include the new definition of current isolates (3.11.1) (see 4.2.2, 5.2.1 of the.2010 edition);
--- Changed the reproducibility test (see 4.2.5, 5.2.4 of the.2010 edition);
--- Changed the deviation discrimination test (see 4.2.8, 5.2.7 of the.2010 edition);
--- Changed the data analysis and acceptance criteria clauses (see Chapter 5, 5.3, 5.4 of the.2010 edition);
--- Changed the accuracy of the equipment under test and deleted the classification compliance (see 5.1, 5.4.1 of the.2010 edition);
--- Changed the data analysis of MIC equipment, deleted the classification compliance, and added bias requirements (see 5.1.1, 5.1.2,.2010 edition
5.2.7);
--- Deleted the acceptance of breakpoint AST equipment (see 5.2.4 of the.2010 edition);
--- Added acceptance criteria for qualitative AST equipment, including sensitivity and specificity requirements (see 5.1.3);
--- Changed the quality control of the test equipment and the reproducibility of the test equipment (see 5.2, 5.3, 5.4.2, 5.4.3 of the.2010 edition).
This document is equivalent to ISO 20776-2.2021 "Clinical laboratory test and in vitro diagnostic system for infectious pathogens susceptibility testing and
Performance evaluation of equipment for antimicrobial susceptibility testing - Part 2.Antimicrobial agents compared with a broth microdilution reference method
Performance Evaluation of Sensitivity Test Equipment.
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Technical Committee for Standardization of Medical Clinical Testing Laboratories and In Vitro Diagnostic Systems (SAC/TC136).
This document was drafted by. Beijing Institute of Medical Device Inspection (Beijing Medical Biological Protection Equipment Inspection and Research Center), China Medical
Peking Union Medical College Hospital, Huashan Hospital Affiliated to Fudan University, BioMérieux Diagnostics (Shanghai) Co., Ltd., Becton Dickinson Medical Devices (Shanghai)
Co., Ltd., Shanghai Clinical Laboratory Center, and Shandong Medical Device and Drug Packaging Inspection Institute.
The main drafters of this document are. Bi Chunlei, Xu Yingchun, Hu Fupin, Wang Shaoying, Cheng Lili, Wang Jinghua and Li Chengzhi.
The previous versions of this document and the documents it replaces are as follows.
---First published in.2010 as YY/T 0688.2-2010;
--- This is the first revision.
Introduction
In vitro antimicrobial susceptibility testing is usually performed on microorganisms that may cause disease, especially those that are considered to be resistant to commonly used antibiotics.
In addition, the test is also used in bacterial resistance monitoring, epidemiological studies of sensitivity, and new
Aspects such as comparisons between antimicrobial agents and existing antimicrobial agents are also important.
Antimicrobial susceptibility testing is a method for determining the minimum inhibitory concentration (MIC) of antimicrobial drugs using a dilution method.
Monitoring of bacterial resistance, defining and identifying wild-type phenotypes, comparative testing of new antimicrobial agents, and clinical
Microbiological tests that require quantitative results are used to determine the sensitivity of microorganisms that give equivocal results in conventional testing.
The test involves testing the microorganisms in a series of dilutions of the antimicrobial agent in broth (broth dilution method) or on agar plates (agar dilution method).
The ability of an organism to grow visibly.
The minimum inhibitory concentration of an antimicrobial drug refers to the concentration that can inhibit the growth of a specific microorganism under specified in vitro conditions and within a specified time.
The lowest concentration of an antimicrobial drug (in mg/L) that produces visible growth is known as the MIC.
The reproducibility of the soup MIC test requires strict quality control and standardized operation. The MIC distribution range of quality control (QC) strains is generally
There is a 3-fold dilution range with a main central value, but there can also be a 4-fold dilution range.
The broth microdilution method is a broth dilution test performed in a microdilution plate.
One of the microbial sensitivity test methods.
This document is equivalent to ISO 20776-2.2021 and is intended to evaluate the efficacy of antibiotics based on the standard broth microdilution reference method (ISO 20776-1).
Microbiological test equipment. Use pure cultures of readily grown aerobic bacteria grown overnight on agar in a solution containing standardized Mueler-
Grows well in standardized microdilution plates in Hinton broth (volume ≤.200 μL).
Make adjustments.
The quantitative MIC and qualitative assessments detailed in this document are measured using a standard broth microdilution reference method.
The accuracy, reproducibility and quality control of tests performed by equipment testing antimicrobial drugs with MIC values. This document does not cover antimicrobial
Agar disc diffusion test.
This document has been revised on the premise that the MIC test is an in vitro test that is subject to intra- and inter-laboratory variability.
In comparing any derived test to a reference method, it is appropriate to use only indicators of analytical performance and not the interpretation of the results.
For this reason, and because the interpretive categories have been removed from ISO 20776-1.2019, the classification is consistent with (CA) and its related terms.
The term is no longer applicable, as described in the Clinical and Laboratory Standards Institute (CLSI) M23 document and other international documents.
Avoiding the need to evaluate the CA when changes (outside of the test itself) occur also helps reduce the need to automatically re-evaluate test performance.
This document is applicable to new performance evaluations initiated after the publication of the standard; studies conducted before the acceptance date of this document should not use these
Standard redesign and/or reanalysis. Studies conducted prior to these standards or acceptance of this document were conducted in accordance with standard practice at the time of the study or
guide.
For derivatization experiments with more than 3 dilution series, analytical performance was measured using a protocol designed to measure both essential agreement (EA) and bias.
The accuracy of the assay was evaluated using the EA alone as a tool to measure precision.
Performance was assessed using standard sensitivity and specificity metrics.
Clinical laboratory testing and in vitro diagnostics for systemic infectious diseases
Pathogen susceptibility testing and antimicrobial susceptibility
Performance evaluation of test equipment Part 2.Broth
Antimicrobial drugs compared with microdilution reference methods
Sensitivity test equipment performance evaluation
1 Scope
This document establishes acceptable performance criteria for antimicrobial susceptibility testing (AST) equipment.
Used to determine the minimum inhibitory concentration (MIC) of antimicrobial drugs against bacteria.
This document specifies the requirements for AST equipment and the procedures for evaluating the performance of these equipment.
Can be evaluated.
This document is intended to guide manufacturers in conducting performance evaluation studies.
2 Normative references
The contents of the following documents constitute the essential clauses of this document through normative references in this text.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
ISO 20776-1 Performance evaluation of equipment for susceptibility testing of infectious pathogens and antimicrobial susceptibility testing Part 1.
Broth microdilution reference method for in vitro activity testing of microbial agents against rapidly growing aerobic bacteria associated with infectious diseases (Suscepti-
Note. YY/T 0688.1-2023 Performance evaluation of infectious pathogen sensitivity test and antimicrobial drug sensitivity test equipment Part 1.Antimicrobial
Broth microdilution reference method for in vitro activity testing of biopharmaceuticals against rapidly growing aerobic bacteria associated with infectious diseases (ISO 20776-1.
2019, IDT)
3 Terms and definitions
The following terms and definitions apply to this document.
The terminology databases maintained by ISO and IEC for use in standardization work are listed below.
3.1
ASTdevice
Equipment, including all specific components used to obtain test results that allow the use of specific antimicrobial agents to treat bacteria
MIC determination was performed.
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