GB/T 40672-2021 (English Version) PDF

Scope: This document provides standard descriptions and performance criteria for the physical properties of dehydrated MH broth (dMHB) and dehydrated MH agar (dMHA) so that manufacturers can evaluate the performance characteristics of their dMHB and dMHA production batches. Production batches of broth or agar can then be used by all users, including manufacturers of in vitro susceptibility testing devices, as media for antimicrobial susceptibility testing. This document does not describe additives (such as blood or blood products) added to the medium to support the growth of fastidious bacteria (CLSI side. These additives are added as a final product when the dehydrated medium is prepared as a liquid, and are outside the scope of this document. Although [ 3][4][5][6] method)[][]dMHA can be used for agar dilution method4 6 or gradient diffusion method to determine MIC, this document only contains information according to American Clinical and Laboratory Standards Association[][]( CLSI)5 and the European Committee for Antimicrobial Susceptibility Testing (EUCAST)3 performance tests using the disk diffusion method.

GB/T 40672-2021 Referenced Document

ISO 20776-1 Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 1: Refe
YY/T 0688.1-2008 Clinical laboratory testing and in vitro diagnostic test systems -Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility devices -Part 1: Reference method for testing the in vitro activity of antimicrobia

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