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 药敏试验用脱水MH琼脂和肉汤的可接受批量标.pdf

1、Clinical laboratory testing Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing PD ISO/TS 16782:2016 BSI Standards Publication WB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National foreword This Published Document is the UK imp

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

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

4、 under the authority of the Standards Policy and Strategy Committee on 30 November 2016. Amendments/corrigenda issued since publication Date Text affected PUBLISHED DOCUMENT PD ISO/TS 16782:2016 ISO 2016 Clinical laboratory testing Criteria for acceptable lots of dehydrated Mueller-Hinton agar and b

5、roth for antimicrobial susceptibility testing Dtermination de la sensibilit aux antibiotiques Critres dacceptabilit pour les lots dagar dshydrat et de bouillon Mueller- Hinton pour dterminer la sensibilit aux antibiotiques TECHNICAL SPECIFICATION ISO/TS 16782 Reference number ISO/TS 16782:2016(E) Fi

6、rst edition 2016-10-15 PD ISO/TS 16782:2016 ISO/TS 16782:2016(E)ii ISO 2016 All rights reserved 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 m

7、eans, 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 ISOs member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 CP 401 C

8、H-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyrightiso.org www.iso.org PD ISO/TS 16782:2016 ISO/TS 16782:2016(E)Foreword iv Introduction v 1 Scope . 1 2 Normative reference . 1 3 T erms and definitions . 1 4 Requirements for Mueller-Hinton broth . 3 4.1 Component

9、s 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

10、 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 gran

11、ules 6 5.2.2 Prepared agar medium . 7 5.2.3 Cation supplementation and content for MHA 7 5.2.4 Other medium components 7 5.2.5 Specific adjustments required by the manufacturer 7 5.3 Manufacturers protocol for testing production lots of dehydrated Mueller-Hinton agar 8 5.4 Interpreting the results .

12、 8 5.5 Evaluating the results .10 6 Testing new antimicrobial agents with production lots of dehydrated Mueller- Hinton broth or agar 11 Annex A (informative) Mueller-Hinton medium .12 Annex B (informative) Preparing control cultures .14 Annex C (informative) Suggested data sheet for testing of prod

13、uction lots .16 Annex D (informative) Label statement .19 Bibliography .20 ISO 2016 All rights reserved iii Contents Page PD ISO/TS 16782:2016 ISO/TS 16782:2016(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bod

14、ies). The work of preparing Technical Specifications is normally carried out through 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 an

15、d non-governmental, in liaison with ISO, also take part in the work. ISO collaborates 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 d

16、escribed in the ISO/IEC Directives, Part 1. In particular the different approval criteria 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 dra

17、wn to the possibility that some of the elements of this document may be the subject of 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

18、the ISO list of patent declarations received (see www.iso.org/patents). Any trade name 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 assessm

19、ent, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information The committee responsible for this document is ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems.iv I

20、SO 2016 All rights reserved PD ISO/TS 16782:2016 ISO/TS 16782:2016(E) Introduction Historically, 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

21、 (MIC) method (ISO 20776-1) and Mueller-Hinton agar (MHA) is most widely used for disc diffusion 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 tet

22、racycline inhibitors and a large amount of data has been collected from antimicrobial susceptibility 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-Hinto

23、n agar (dMHA) and broth (dMHB) may determine its acceptable performance characteristics. The results 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 o

24、f antimicrobial agents and quality control strains. This Technical Specification has been developed in part based upon two Clinical and Laboratory Standards Institute (CLSI) documents, CLSI M6-A2 1(protocols for evaluating dehydrated Mueller- Hinton agar) and CLSI M32-P 2(evaluation of lots of dehyd

25、rated Mueller-Hinton broth for antimicrobial susceptibility testing) with permission. Upon publication of ISO 16782, CLSI documents M6-A2 1and M32-P 2will no longer be available. Manufacturers can follow ISO 16782 to assess the performance characteristics of their production lots of dMHA and dMHB. I

26、SO 2016 All rights reserved v PD ISO/TS 16782:2016 Clinical laboratory testing Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing 1 Scope This Technical Specification provides a standard description of the physical properties of dehydrat

27、ed 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 te

28、sting 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 3456 . Those additives are provided a

29、fter 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 46or the gradient diffusion method, this Technical Specification only includ

30、es performance testing of dMHA using disc diffusion methodology as described by the Clinical and Laboratory Standards Institute (CLSI) 5and European Committee on Antimicrobial Susceptibility Test ing (EUC AST ) 3 . 2 Normative reference The following documents, in whole or in part, are normatively r

31、eferenced in this document and are indispensable for its application. For dated references, only the edition cited 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

32、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 M100, P

33、erformance Standards for Antimicrobial Susceptibility Testing; Informational Supplement 3 T erms a nd definiti ons For the purposes of this document, the following terms and definitions apply. 3.1 antimicrobial agent substance of biological, semi-synthetic or synthetic origin that inhibits the growt

34、h of or kills bacteria and is thus of potential use in the treatment of infections Note 1 to entry: Disinfectants, antiseptics and preservatives are not included in this definition. SOURCE: ISO 20776-1:2006, 2.1 3.2 antimicrobial disc small paper disc containing known amounts of antimicrobial agents

35、 used for in vitro susceptibility testing TECHNICAL SPECIFICATION ISO/TS 16782:2016(E) ISO 2016 All rights reserved 1 PD ISO/TS 16782:2016 ISO/TS 16782:2016(E) 3.3 concentration amount of an antimicrobial agent in a defined volume of liquid Note 1 to entry: The concentration is expressed as mg/l. No

36、te 2 to entry: mg/l = g/ml but it is not recommended to use the unit g/ml. SOURCE: ISO 20776-1:2006, 2.2.2 3.4 stock solution initial solution used for further dilutions SOURCE: ISO 20776-1:2006, 2.3 3.5 minimum inhibitory concentration MIC lowest concentration of antimicrobial agent that, under def

37、ined in vitro conditions, prevents visible growth of bacteria within a defined period of time Note 1 to entry: The MIC is expressed in mg/l. SOURCE: ISO 20776-1:2006, 2.4, modified “lowest concentration that” has been modified to “lowest concentration of antimicrobial agent that” 3.6 reference strai

38、n catalogued, characterized microorganism with stable, defined antimicrobial susceptibility phenotype and/or genotype Note 1 to entry: Reference strains are kept as stock cultures, from which working cultures are derived. They are obtained from recognized national culture collections and used for qu

39、ality control. SOURCE: ISO 20776-1:2006, 2.7, modified “characterized bacteria” has been modified to “characterized microorganism” and “culture collections” in Note 1 to entry has been modified to “recognized national culture collections” 3.7 Susceptibility testing method 3.7.1 broth dilution techni

40、que in which containers are filled with appropriate volumes of broth containing an antimicrobial agent in incrementally (usually two-fold) increasing concentrations and a defined inoculum Note 1 to entry: The aim of this method is the determination of the MIC. SOURCE: ISO 20776-1:2006, 2.8.1, modifi

41、ed “an antimicrobial solution, employing incrementally (usually two-fold) increasing concentrations of the antimicrobial agent and appropriate volumes of broth with” has been modified to “broth containing an antimicrobial agent in incrementally (usually two-fold) increasing concentrations and” 3.7.2

42、 microdilution performance of broth dilution in microdilution trays with a capacity of 200 l per well SOURCE: ISO 20776-1:2006, 2.8.2, modified “a capacity of 200 l per well” has been modified to “a capacity of 200 l per well”2 ISO 2016 All rights reserved PD ISO/TS 16782:2016 ISO/TS 16782:2016(E) 3

43、.7.3 disc diffusion technique in which antimicrobial discs are applied to the surface of an agar medium that has been evenly inoculated with a defined inoculum and, following incubation under defined conditions, the resulting size of zones of growth inhibition of the microorganism corresponds to the

44、 susceptibility/resistance of the microorganism to the antimicrobial agent 3.7.4 zone diameter diameter (in mm) of the zone of growth inhibition around a paper disc containing an antimicrobial agent of specified amount used in a disc diffusion test 3.8 broth liquid medium used for the in vitro growt

45、h of bacteria SOURCE: ISO 20776-1:2006, 2.9, modified “fluid medium” has been modified to “liquid medium” 3.9 inoculum number of viable bacteria in a suspension, calculated with respect to the final volume Note 1 to entry: The inoculum is expressed as colony-forming units per millilitre (CFU/ml). SO

46、URCE: ISO 20776-1:2006, 2.10, modified “number of bacteria” has been modified to “number of viable bacteria” 3.10 dehydrated Mueller-Hinton broth dMHB dried bacteriological medium which is used to prepare liquid medium for broth dilution antimicrobial susceptibility tests 3.11 dehydrated Mueller-Hin

47、ton agar dMHA dried bacteriological medium which is used to prepare antimicrobial susceptibility testing agar plates for disc diffusion, gradient diffusion MIC and agar dilution MIC methods 4 Requirements for Mueller-Hinton broth 4.1 Components of Mueller-Hinton broth Historically, Mueller-Hinton br

48、oth medium for antimicrobial susceptibility testing contains approximately the following components per litre of purified water (adjustments may be needed to meet performance criteria) 7 : dehydrated infusion from 300 g beef (i.e. 2 g of beef extract powder); acid digest of casein 17,5 g; starch 1,5

49、 g. 4.2 Physical and chemical characteristics 4.2.1 Dehydrated powder or granules Colour: beige to light beige. Uniform, free-flowing, homogeneous and free of extraneous material. ISO 2016 All rights reserved 3 PD ISO/TS 16782:2016 ISO/TS 16782:2016(E) 4.2.2 Prepared broth medium Once 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