BS PD ISO TS 16782-2016 Clinical laboratory testing Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing《临床实验室试验 药敏试验用脱.pdf

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1、Clinical laboratory testing Criteria for acceptable lots of dehydrated Mueller-Hintonagar and broth for antimicrobialsusceptibility testingPD ISO/TS 16782:2016BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis Published Document is the UK implement

2、ation of ISO/TS 16782:2016. The UK participation in its preparation was entrusted to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions ofa contract

3、. Users are responsible for its correct application. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 95546 4ICS 11.100.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This Published Document was published under the author

4、ity of theStandards Policy and Strategy Committee on 30 November 2016.Amendments/corrigenda issued since publicationDate Text affectedPUBLISHED DOCUMENTPD ISO/TS 16782:2016 ISO 2016Clinical laboratory testing Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial

5、susceptibility testingDtermination de la sensibilit aux antibiotiques Critres dacceptabilit pour les lots dagar dshydrat et de bouillon Mueller-Hinton pour dterminer la sensibilit aux antibiotiquesTECHNICAL SPECIFICATIONISO/TS16782Reference numberISO/TS 16782:2016(E)First edition2016-10-15PD ISO/TS

6、16782:2016ISO/TS 16782:2016(E)ii ISO 2016 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in SwitzerlandAll 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, incl

7、uding 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 ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel.

8、 +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgPD ISO/TS 16782:2016ISO/TS 16782:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative reference . 13 Terms and definitions . 14 Requirements for Mueller-Hinton broth . 34.1 Components of Mueller-Hinton broth 34.2 Physical and chemical

9、 characteristics . 34.2.1 Dehydrated powder or granules 34.2.2 Prepared broth medium 44.2.3 Cation supplementation and content for MHB 44.2.4 Other medium components 44.2.5 Specific adjustments required by the manufacturer 44.3 Manufacturers protocol for testing production lots of dehydrated Mueller

10、-Hinton broth . 54.4 Interpreting the results . 54.5 Evaluating the results 65 Requirements for Muller-Hinton agar . 65.1 Components of Mueller-Hinton agar . 65.2 Physical and chemical characteristics . 65.2.1 Dehydrated powder or granules 65.2.2 Prepared agar medium . 75.2.3 Cation supplementation

11、and content for MHA 75.2.4 Other medium components 75.2.5 Specific adjustments required by the manufacturer 75.3 Manufacturers protocol for testing production lots of dehydrated Mueller-Hinton agar 85.4 Interpreting the results . 85.5 Evaluating the results . 106 Testing new antimicrobial agents wit

12、h production lots of dehydrated Mueller-Hinton broth or agar 11Annex A (informative) Mueller-Hinton medium .12Annex B (informative) Preparing control cultures .14Annex C (informative) Suggested data sheet for testing of production lots .16Annex D (informative) Label statement .19Bibliography .20 ISO

13、 2016 All rights reserved iiiContents PagePD ISO/TS 16782:2016ISO/TS 16782:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing Technical Specifications is normally carried out throug

14、h ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborat

15、es closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval cri

16、teria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject o

17、f patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name

18、 used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical

19、 Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems.iv ISO 2016 All rights reservedPD ISO/TS 16782:2016ISO/TS 16782:2016(E)IntroductionHistorica

20、lly, although various media have been recommended for susceptibility testing, Mueller-Hinton broth (MHB) has been selected as the medium for the reference broth microdilution minimum inhibitory concentration (MIC) method (ISO 20776-1) and Mueller-Hinton agar (MHA) is most widely used for disc diffus

21、ion testing of rapidly growing bacteria.Mueller-Hinton medium provides satisfactory growth of most non-fastidious pathogens, acceptable batch-to-batch reproducibility, low sulfonamide, trimethoprim, and tetracycline inhibitors and a large amount of data has been collected from antimicrobial suscepti

22、bility tests with this medium over several decades.This International Standard is the result of an effort to establish a standard description and protocol by which manufacturers of dehydrated Mueller-Hinton agar (dMHA) and broth (dMHB) may determine its acceptable performance characteristics.The res

23、ults of testing conform to defined quality control limit ranges for each combination of antimicrobial agent and quality control strains. Each production lot is tested at least against these combinations of antimicrobial agents and quality control strains.This Technical Specification has been develop

24、ed in part based upon two Clinical and Laboratory Standards Institute (CLSI) documents, CLSI M6-A21(protocols for evaluating dehydrated Mueller-Hinton agar) and CLSI M32-P2(evaluation of lots of dehydrated Mueller-Hinton broth for antimicrobial susceptibility testing) with permission. Upon publicati

25、on of ISO 16782, CLSI documents M6-A21and M32-P2will no longer be available. Manufacturers can follow ISO 16782 to assess the performance characteristics of their production lots of dMHA and dMHB. ISO 2016 All rights reserved vPD ISO/TS 16782:2016Clinical laboratory testing Criteria for acceptable l

26、ots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing1 ScopeThis 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 manufactur

27、ers 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.Thi

28、s Technical Specification does not address supplements (e.g. blood or blood products) that are added to the medium to support growth of fastidious bacteria3456. Those additives are provided after the dehydrated medium is prepared in its liquid state as a final product and fall outside of the scope o

29、f this Technical Specification. Although dMHA can be used for determination of MICs using the agar dilution method46or the gradient diffusion method, this Technical Specification only includes performance testing of dMHA using disc diffusion methodology as described by the Clinical and Laboratory St

30、andards Institute (CLSI)5and European Committee on Antimicrobial Susceptibility Test ing (EUC AST )3.2 Normative referenceThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited

31、applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 20776-1:2006, Clinical laboratory testing and in vitro diagnostic test systems Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibili

32、ty test devices Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseasesCLSI M100, Performance Standards for Antimicrobial Susceptibility Testing; Informational Supplement3 Terms and definitionsFor the

33、 purposes of this document, the following terms and definitions apply.3.1antimicrobial agentsubstance of biological, semi-synthetic or synthetic origin that inhibits the growth of or kills bacteria and is thus of potential use in the treatment of infectionsNote 1 to entry: Disinfectants, antiseptics

34、 and preservatives are not included in this definition.SOURCE: ISO 20776-1:2006, 2.13.2antimicrobial discsmall paper disc containing known amounts of antimicrobial agents used for in vitro susceptibility testingTECHNICAL SPECIFICATION ISO/TS 16782:2016(E) ISO 2016 All rights reserved 1PD ISO/TS 1678

35、2:2016ISO/TS 16782:2016(E)3.3concentrationamount of an antimicrobial agent in a defined volume of liquidNote 1 to entry: The concentration is expressed as mg/l.Note 2 to entry: mg/l = g/ml but it is not recommended to use the unit g/ml.SOURCE: ISO 20776-1:2006, 2.2.23.4stock solutioninitial solution

36、 used for further dilutionsSOURCE: ISO 20776-1:2006, 2.33.5minimum inhibitory concentrationMIClowest concentration of antimicrobial agent that, under defined in vitro conditions, prevents visible growth of bacteria within a defined period of timeNote 1 to entry: The MIC is expressed in mg/l.SOURCE:

37、ISO 20776-1:2006, 2.4, modified “lowest concentration that” has been modified to “lowest concentration of antimicrobial agent that”3.6reference straincatalogued, characterized microorganism with stable, defined antimicrobial susceptibility phenotype and/or genotypeNote 1 to entry: Reference strains

38、are kept as stock cultures, from which working cultures are derived. They are obtained from recognized national culture collections and used for quality control.SOURCE: ISO 20776-1:2006, 2.7, modified “characterized bacteria” has been modified to “characterized microorganism” and “culture collection

39、s” in Note 1 to entry has been modified to “recognized national culture collections”3.7 Susceptibility testing method3.7.1broth dilutiontechnique in which containers are filled with appropriate volumes of broth containing an antimicrobial agent in incrementally (usually two-fold) increasing concentr

40、ations and a defined inoculumNote 1 to entry: The aim of this method is the determination of the MIC.SOURCE: ISO 20776-1:2006, 2.8.1, modified “an antimicrobial solution, employing incrementally (usually two-fold) increasing concentrations of the antimicrobial agent and appropriate volumes of broth

41、with” has been modified to “broth containing an antimicrobial agent in incrementally (usually two-fold) increasing concentrations and”3.7.2microdilutionperformance of broth dilution in microdilution trays with a capacity of 200 l per wellSOURCE: ISO 20776-1:2006, 2.8.2, modified “a capacity of 200 l

42、 per well” has been modified to “a capacity of 200 l per well”2 ISO 2016 All rights reservedPD ISO/TS 16782:2016ISO/TS 16782:2016(E)3.7.3disc diffusiontechnique in which antimicrobial discs are applied to the surface of an agar medium that has been evenly inoculated with a defined inoculum and, foll

43、owing incubation under defined conditions, the resulting size of zones of growth inhibition of the microorganism corresponds to the susceptibility/resistance of the microorganism to the antimicrobial agent3.7.4zone diameterdiameter (in mm) of the zone of growth inhibition around a paper disc contain

44、ing an antimicrobial agent of specified amount used in a disc diffusion test3.8brothliquid medium used for the in vitro growth of bacteriaSOURCE: ISO 20776-1:2006, 2.9, modified “fluid medium” has been modified to “liquid medium”3.9inoculumnumber of viable bacteria in a suspension, calculated with r

45、espect to the final volumeNote 1 to entry: The inoculum is expressed as colony-forming units per millilitre (CFU/ml).SOURCE: ISO 20776-1:2006, 2.10, modified “number of bacteria” has been modified to “number of viable bacteria”3.10dehydrated Mueller-Hinton brothdMHBdried bacteriological medium which

46、 is used to prepare liquid medium for broth dilution antimicrobial susceptibility tests3.11dehydrated Mueller-Hinton agardMHAdried bacteriological medium which is used to prepare antimicrobial susceptibility testing agar plates for disc diffusion, gradient diffusion MIC and agar dilution MIC methods

47、4 Requirements for Mueller-Hinton broth4.1 Components of Mueller-Hinton brothHistorically, Mueller-Hinton broth medium for antimicrobial susceptibility testing contains approximately the following components per litre of purified water (adjustments may be needed to meet performance criteria)7: dehyd

48、rated infusion from 300 g beef (i.e. 2 g of beef extract powder); acid digest of casein 17,5 g; starch 1,5 g.4.2 Physical and chemical characteristics4.2.1 Dehydrated powder or granulesColour: beige to light beige.Uniform, free-flowing, homogeneous and free of extraneous material. ISO 2016 All right

49、s reserved 3PD ISO/TS 16782:2016ISO/TS 16782:2016(E)4.2.2 Prepared broth mediumOnce hydrated, the final pH measured after autoclaving shall be 7,2 to 7,4 at 25 C.The liquid is light straw coloured and clear with no visible precipitate.4.2.3 Cation supplementation and content for MHBThe broth shall contain sufficient concentrations of cations to provide adequate growth and to permit the user to determine MIC values (e.g. aminoglycosides and quinolones) for quality