PD ISO/TS 16782:2016

This standard PD ISO/TS 16782:2016 Clinical laboratory testing. Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing is classified in these ICS categories:

• 11.100.20 Biological evaluation of medical devices

This Technical Specification provides a standard description of the physical properties of dehydrated Mueller-Hinton broth (dMHB) and Mueller-Hinton agar (dMHA) and performance criteria by which manufacturers can assess the performance characteristics of their production lots of dMHA and dMHB. Production lots of broth or agar can then be utilized by all users, including in vitro susceptibility testing device manufacturers, as the test medium for performance of antimicrobial susceptibility testing.

This Technical Specification does not address supplements (e.g. blood or blood products) that are added to the medium to support growth of fastidious bacteria^[3][4][5][6]. Those additives are provided after the dehydrated medium is prepared in its liquid state as a final product and fall outside of the scope of this Technical Specification. Although dMHA can be used for determination of MICs using the agar dilution method^[4][6] or the gradient diffusion method, this Technical Specification only includes performance testing of dMHA using disc diffusion methodology as described by the Clinical and Laboratory Standards Institute (CLSI)^[5] and European Committee on Antimicrobial Susceptibility Testing (EUCAST)^[3].