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PD ISO/TS 16782:2016

Current

Current

The latest, up-to-date edition.

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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

30-11-2016

€231.38
Excluding VAT

Foreword
Introduction
1 Scope
2 Normative reference
3 Terms and definitions
4 Requirements for Mueller-Hinton broth
5 Requirements for Muller-Hinton agar
6 Testing new antimicrobial agents with production lots
  of dehydrated Mueller-Hinton broth or agar
Annex A (informative) - Mueller-Hinton medium
Annex B (informative) - Preparing control cultures
Annex C (informative) - Suggested data sheet for testing
        of production lots
Annex D (informative) - Label statement
Bibliography

Gives 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.

Committee
CH/212
DocumentType
Standard
Pages
30
PublisherName
British Standards Institution
Status
Current

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

Standards Relationship
ISO/TS 16782:2016 Identical

CLSI M32 P : 1ED 2001 EVALUATION OF LOTS OF DEHYDRATED MUELLER-HINTON BROTH FOR ANTIMICROBIAL SUSCEPTIBILITY TESTING
CLSI M6 A2 : 2ED 2006 PROTOCOLS FOR EVALUATING DEHYDRATED MUELLER-HINTON AGAR
ISO 20776-1:2006 Clinical laboratory testing and in vitro diagnostic test systems Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases
CLSI M2 A12 : 12ED 2015 PERFORMANCE STANDARDS FOR ANTIMICROBIAL DISK SUSCEPTIBILITY TESTS
CLSI M7 A10 : 10ED 2015 METHODS FOR DILUTION ANTIMICROBIAL SUSCEPTIBILITY TESTS FOR BACTERIA THAT GROW AEROBICALLY

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