ISO/TS 16782:2016
Clinical laboratory testing — Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
Clinical laboratory testing — Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 21
- Дата публикации:
- 20 октября 2016 г.
- Издание:
- ISO TS 16782 edition 1 version 1
- ICS:
- 11.100.20
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].
Abstract
Overview
ISO/TS 16782:2016 - Clinical laboratory testing - Criteria for acceptable lots of dehydrated Mueller‑Hinton agar and broth for antimicrobial susceptibility testing - specifies how manufacturers and users assess production lots of dehydrated Mueller‑Hinton broth (dMHB) and dehydrated Mueller‑Hinton agar (dMHA) for use in antimicrobial susceptibility testing (AST). The Technical Specification defines physical and chemical characteristics, performance criteria, and lot‑testing protocols so that dMHB/dMHA lots can be reliably used for AST methods (notably disk diffusion and broth microdilution).
Key phrases: ISO/TS 16782:2016, dehydrated Mueller‑Hinton agar, dehydrated Mueller‑Hinton broth, antimicrobial susceptibility testing, dMHA, dMHB.
Key Topics
- Scope and exclusions
- Covers physical properties and performance criteria for dehydrated MH media lots.
- Excludes supplements (e.g., blood or blood products) added later to support fastidious organisms.
- For dMHA, performance testing in this TS is limited to disk diffusion as described by CLSI and EUCAST.
- Physical and chemical specifications
- Prepared MHB: pH 7.2–7.4 (25 °C); light straw coloured, clear, no precipitate.
- Dehydrated powder: uniform, free‑flowing, beige to light beige.
- Cation content and supplementation
- Cation concentrations influence MICs and disk diffusion-critical for agents such as aminoglycosides and quinolones.
- Typical final prepared MHB targets: 20–25 mg/L Ca and 10–12.5 mg/L Mg (production lots ≤25 mg/L Ca and ≤12.5 mg/L Mg; manufacturers may label actual levels if
Технические детали
- Технический комитет
- ISO/TC 212 - Clinical laboratory testing and in vitro diagnostic test systems
- SKU
- ISO/TS 16782:2016
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