ISO/TS 16782:2016

Clinical laboratory testing — Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing

Standard Details

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 StandardDetails Institute (CLSI)[5] and European Committee on Antimicrobial Susceptibility Testing (EUCAST)[3].

General Information

Status : Published

Standard Type: Main

Document No: ISO/TS 16782:2016

Document Year: 2016

Pages: 21

Edition: 1

Section Volume:
ISO/TC 212. Clinical laboratory testing and in vitro diagnostic test systems

ICS:
11.100.20 Biological evaluation of medical devices

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ISO/TS 16782:2016

ISO/TS 16782:2016

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