90.60 Close of review Sep 3, 2024
ISO
ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
Technical Specification
11.100.20 Biological evaluation of medical devices
ISO/TS 16782:2016 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.
ISO/TS 16782:2016 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, ISO/TS 16782:2016 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].
ABANDON
ISO/PRF 16782
PUBLISHED
ISO/TS 16782:2016
90.60
Close of review
Sep 3, 2024