ISO/PRF 16782

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

General Information

• Status: Withdrawn
• 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: 5098 - Project deleted
• Completion Date: 04-Aug-2016

Relations

• Replaced By: ISO/TS 16782:2016 - Clinical laboratory testing — Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
• Effective Date: 13-Aug-2016

Standards Content (Sample)

DRAFT INTERNATIONAL STANDARD
ISO/DIS 16782
ISO/TC 212 Secretariat: ANSI
Voting begins on: Voting terminates on:
2014-06-26 2014-11-26
Clinical laboratory testing - Criteria for acceptable
lots of dehydrated Mueller-Hinton agar and broth for
antimicrobial susceptibility testing
Critères pour des lots acceptables d’Agar déshydraté Mueller-Hinton et de bouillon pour essai de
susceptibilité antimicrobienne
ICS: 11.100.20
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments
received, will be submitted to a parallel two-month approval vote in ISO and
THIS DOCUMENT IS A DRAFT CIRCULATED
formal vote in CEN.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
To expedite distribution, this document is circulated as received from the
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
composition will be undertaken at publication stage.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 16782:2014(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2014

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ISO/DIS 16782:2014(E)

Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as
permitted under the applicable laws of the user’s country, neither this ISO draft nor any extract
from it may be reproduced, stored in a retrieval system or transmitted in any form or by any means,
electronic, photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO’s
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Tel. + 41 22 749 01 11
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Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2014 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/DIS 16782
Contents Page
Foreword . iv
Introduction . iv
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 . 3
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 .
...

© ISO 2014 – All rights reserved
ISO TC 212
Date: 2014‐05‐6
ISO 16782:2014(E)
ISO TC 212/WG 4
Secretariat: ANSI
Antimicrobial susceptibility testing — Criteria for acceptable lots of
dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility
testing
Élément introductif — Élément central — Élément complémentaire
Document type: International Standard
Document subtype:
Document stage: (60) Publication
Document language: E

D:\ISO\isomacroserver‐prod\temp\DOC2PDFRGB2010\DOC2PDFRGB2010.innodata‐
ds@VMWIN7_337\C057706e_trackchanges.doc STD Version 2.1c2

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ISO 16782:2014(E)
Copyright notice
This ISO document is a Draft International Standard and is copyright‐protected by ISO. Except as
permitted under the applicable laws of the user's country, neither this ISO draft nor any extract
from it may be reproduced, stored in a retrieval system or transmitted in any form or by any
means, electronic, photocopying, recording or otherwise, without prior written permission being
secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH‐1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E‐mail [e-mail]
Web www.iso.org www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2014 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 16782:2014(E)
ontents Page
Foreword iv
Introduction iv
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 . 3
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 . 6
5.2.3 Cation supplementation and content for MHA . 7
5.2.4 Other medium components . 7
5.2.5 Specific adjustments
...

INTERNATIONAL ISO
STANDARD 16782
First edition
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
PROOF/ÉPREUVE
Reference number
ISO 16782:2015(E)
©
ISO 2015

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ISO 16782:2015(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, 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. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2015 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 16782:2015(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 . 3
4.2.3 Cation supplementation and content for MHB . 3
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 .
...