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ISO/TS 16782:2016

(Main)

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

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].

Détermination de la sensibilité aux antibiotiques — Critères d'acceptabilité pour les lots d'agar déshydraté et de bouillon Mueller-Hinton pour déterminer la sensibilité aux antibiotiques

General Information

Status
Published
Publication Date
19-Oct-2016
ICS
11.100.20 - Biological evaluation of medical devices
Technical Committee
ISO/TC 212 - Clinical laboratory testing and in vitro diagnostic test systems
Drafting Committee
ISO/TC 212 - Clinical laboratory testing and in vitro diagnostic test systems
Current Stage
9020 - International Standard under periodical review
Start Date
15-Apr-2024
Completion Date
15-Apr-2024
Ref Project

Relations

Replaces
ISO/PRF 16782 - Clinical laboratory testing — Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
Effective Date
13-Aug-2016

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ISO/TS 16782:2016 - Clinical laboratory testing -- Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testingISO/TS 16782:2016 - Clinical laboratory testing -- Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
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Technical specification
ISO/TS 16782:2016 - Clinical laboratory testing -- Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
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Standards Content (Sample)

TECHNICAL ISO/TS
SPECIFICATION 16782
First edition
2016-10-15
Clinical laboratory testing — Criteria
for acceptable lots of dehydrated
Mueller-Hinton agar and broth for
antimicrobial susceptibility testing
Détermination de la sensibilité aux antibiotiques — Critères
d’acceptabilité pour les lots d’agar déshydraté et de bouillon Mueller-
Hinton pour déterminer la sensibilité aux antibiotiques
Reference number
ISO/TS 16782:2016(E)
©
ISO 2016

---------------------- Page: 1 ----------------------
ISO/TS 16782:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/TS 16782:2016(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative reference . 1
3 Terms and definitions . 1
4 Requirements for Mueller-Hinton broth . 3
4.1 Components of Mueller-Hinton broth . 3
4.2 Physical and chemical characteristics . 3
4.2.1 Dehydrated powder or granules . 3
4.2.2 Prepared broth medium . 4
4.2.3 Cation supplementation and content for MHB . 4
4.2.4 Other medium components . . 4
4.2.5 Specific adjustments required by the manufacturer . 4
4.3 Manufacturers protocol for testing production lots of dehydrated Mueller-Hinton broth . 5
4.4 Interpreting the results . 5
4.5 Evaluating the results . 6
5 Requirements for Muller-Hinton agar . 6
5.1 Components of Mueller-Hinton agar . 6
5.2 Physical and chemical characteristics . 6
5.2.1 Dehydrated powder or granules . 6
5.2.2 Prepared agar medium .
...

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