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YY/T 0688.1-2023Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (English PDF)

感染病原体敏感性试验与抗微生物药物敏感性试验设备的性能评价第1部分：抗微生物药物对感染性疾病快速生长需氧菌的体外活性检测的参考方法

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

March 14, 2023

Implementation date

November 1, 2023

Scope

YY/T 0688.1-2023 is the English-translated version of 感染病原体敏感性试验与抗微生物药物敏感性试验设备的性能评价第1部分：抗微生物药物对感染性疾病快速生长需氧菌的体外活性检测的参考方法.

YY/T 0688.1-2023 is the Chinese standard "Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases".

Its scope clause reads: This document describes a reference method for the determination of MIC values for antimicrobial drugs - the broth microdilution method: MIC value can give doctors As a guide, which reflects the antimicrobial activity of an antimicrobial under defined in vitro test conditions, considerations such as drug pharmacology, Other factors such as pharmacokinetics or mechanisms of bacterial resistance: This allows bacteria to be classified as "susceptible (S)", "intermediate (I)" or "resistant (R)": Other In addition, the distribution of MIC values can be used to determine wild-type or non-wild-type bacterial communities: Although the clinical interpretation of MIC values is beyond the scope of this document range, but adjustments to the basic approach for some antimicrobial-bacteria combinations are necessary for clinical interpretation: These tweak packs Included in a separate appendix to this document: In order to ensure the comparability and reliability of test results, other drug susceptibility test methods (such as disk diffusion method or Diagnostic test equipment) It is necessary to compare with this reference method for confirmation: This document applies to the determination of MIC values using the broth microdilution method:. Its clauses include terms and definitions.

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Document preview — YY/T 0688.1-2023

National Standard of the People's Republic of China

ICS: 11.100/10
Classification: C30
Replacing: YY/T 0688.1-2008

Issued by: National Medical Products Administration

Preface
Introduction
1 Scope
2 Normative references
3 Terms and Definitions
4 Test procedure
5 Quality Control
Appendix A (Informative) Mueler-Hinton Broth Medium
Appendix B (informative) Solvents and diluents for the preparation of stock solutions of specific antimicrobial drugs
Appendix D (informative) Special test conditions

1 Scope

This document describes a reference method for the determination of MIC values for antimicrobial drugs - the broth microdilution method: MIC value can give doctors

As a guide, which reflects the antimicrobial activity of an antimicrobial under defined in vitro test conditions, considerations such as drug pharmacology,

Other factors such as pharmacokinetics or mechanisms of bacterial resistance: This allows bacteria to be classified as "susceptible (S)", "intermediate (I)" or "resistant (R)": Other

In addition, the distribution of MIC values can be used to determine wild-type or non-wild-type bacterial communities: Although the clinical interpretation of MIC values is beyond the scope of this document range, but adjustments to the basic approach for some antimicrobial-bacteria combinations are necessary for clinical interpretation: These tweak packs

Included in a separate appendix to this document: In order to ensure the comparability and reliability of test results, other drug susceptibility test methods (such as disk diffusion method or

Diagnostic test equipment) It is necessary to compare with this reference method for confirmation:

This document applies to the determination of MIC values using the broth microdilution method:

2 Normative references

This document has no normative references:

3 Terms and Definitions

The following terms and definitions apply to this document:

3:1 antimicrobial agent

A class of biologically derived, semi-synthetic or synthetic substances that inhibit or kill microorganisms and may be used in anti-infective therapy:

Note: Disinfectants, sterilants and antiseptics are not within the scope of this definition:

3:2 potency

A measure of the activity of a drug, expressed in terms of the amount required to produce a drug effect of a given strength:

Note: Potency can be expressed as the mass fraction of the components in the test substance in milligrams per gram (mg/g), or the active content in international units per gram (IU/g), or in terms of volume

The percentage content of fraction or mass fraction or the concentration of a substance in moles per liter (mol fraction):

3:3

Concentration concentration

The amount of antimicrobial drug in a defined volume of solution:

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.

Referenced standards

Cited by

Editions of YY/T 0688.1

Edition	Title	Revision	Status
YY/T 0688.1-2023	Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases	current edition	Current
YY/T 0688.1-2008	Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases	previous edition	In force until 2023-11-01

This page sells the current edition, YY/T 0688.1-2023. Earlier editions are listed for reference only.

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