ISO/TS 16782:2016

Clinical laboratory testing — Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing ISO/TS 16782:2016

Publication date:   Oct 20, 2016

General information

90.20 Standard under periodical review   Apr 15, 2024

ISO

ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems

Technical Specification

11.100.20   Biological evaluation of medical devices

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Scope

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].

Life cycle

PREVIOUSLY

ABANDON
ISO/PRF 16782

NOW

PUBLISHED
ISO/TS 16782:2016
90.20 Standard under periodical review
Apr 15, 2024