BS EN 12322-1999 In vitro diagnostic medical devices Culture media for microbiology Performance criteria for culture media《体外诊断医疗装置 微生物培养基 培养基性能标准》.pdf

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1、BRITISH STANDARD BS EN 12322:1999 Incorporating Amendment No. 1 In vitro diagnostic medical devices Culture media for microbiology Performance criteria for culture media The European Standard EN 12322:1999, with the incorporation of amendment A1, has the status of a British Standard ICS 07.100.10 NO

2、 COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN 12322:1999 This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 August 1999 BS

3、I 24 December 2001 ISBN 0 580 32698 5 National foreword This British Standard is the English language version of EN 12322:1999, including amendment A1:2001. The UK participation in its preparation was entrusted to Technical Committee CH/69, In vitro diagnostic systems, which has the responsibility t

4、o: aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations repr

5、esented on this committee can be obtained on request to its secretary. The UK submitted a negative vote to prEN 12322 but the standard received an overall positive vote from CEN Member Bodies and the UK comments were not accepted. The reasons for UK disapproval were as follows. Clause 4, Performance

6、 evaluation. It is not clear how the requirements are to be verified, contrary to the ISO/IEC Directives Part 3:1997. Clause 4.1, General quality criteria. It is expected that manufacturers will use appropriate European and international quality systems standards in conjunction with EN 12322, so inc

7、lusion by cross reference is unnecessary. The verbal form “shall”, used to describe the requirements of a quality assurance scheme, cannot be taken as normative as the standard relates to culture media and not to quality systems, which are outside its scope. Cross-references The British Standards wh

8、ich implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does

9、not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside

10、 front cover, the EN title page, pages 2 to 10, an inside back cover and a back cover. The BSI copyright notice displayed throughout this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date Comments 13482 24 December 2001 Addition of Annex ZAEUROPE

11、AN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 12322 April 1999 +A1 October 2001 ICS 07.100.10 English version In vitro diagnostic medical devices Culture media for microbiology Performance criteria for culture media (includes amendment A1:2001) Dispositifs mdicaux de diagnostic in vitro Milleux de

12、culture de microbiologie Critres de performance des milieux de culture (inclut lamendement A1:2001) In-vitro-Diagnostika Kulturmedien fr die Mikrobiologie Leistungskriterien fr Kulturmedien (enthlt nderung A1:2001) This European Standard was approved by CEN on 16 March 1999. Amendment A1:2001 was ap

13、proved by CEN on 30 September 2001. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and biographical references concerning such nation

14、al standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and noti

15、fied to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland a

16、nd United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1999 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No.

17、EN 12322:1999 + A1:2001 EEN 12322:1999 BSI 24 December 2001 2 Foreword This European Standard has been prepared by Technical Committee CEN/TC 140, In vitro diagnostic medical devices, the Secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, ei

18、ther by publication of an identical text or by endorsement, at the latest by October 1999, and conflicting national standards shall be withdrawn at the latest by October 1999. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade

19、 Association, and supports essential requirements of EU Directive(s). Annex A and Annex B are for information only. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czec

20、h Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Foreword to amendment A1 This amendment EN 12322:1999/A1:2001 to the EN 12322:1999 has been prepared by Technical Committee CE

21、N/TC 140, In vitro diagnostic medical devices, the Secretariat of which is held by DIN. This amendment to the European Standard EN 12322:1999 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2002, and conflicting n

22、ational standards shall be withdrawn at the latest by April 2002. This amendment to the European Standard EN 12322:1999 has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relat

23、ionship with EU Directive(s), see informative Annex ZA, which is an integral part of this standard. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denm

24、ark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword 2 Introduction 3 1S c o p e 3 2 Normative references 3 3 Definitions 3 4 Performance evaluation 4 4.1 General quality c

25、riteria 4 4.2 Control strains 4 4.3 Microbiological quality criteria 5 4.4 Performance evaluation and interpretation of results 6 5 Information to be supplied by the manufacturer 6 6 Documentation 6 Annex A (informative) Guidance on preservation and maintenance of control strains 7 Annex B (informat

26、ive) Bibliography 8 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives 10EN 12322:1999 BSI 24 December 2001 3 Introduction In the microbiology laboratory many tests and procedures depend on culture media being consistent an

27、d providing reproducible results. Several hundreds of formulae of dehydrated culture media are commercially available, and many more designed for specific growth responses or purposes are described in the literature. In addition, in clinical and industrial laboratories, the main objectives are growt

28、h and rapid and sensitive detection of micro-organisms. The requirements for media are specific to both the sample and the organism(s) to be detected. Standardized culture media are therefore a prerequisite for any reliable microbiological work (see Annex B 1), and it is of primary importance to def

29、ine the major objectives and criteria related to how a culture medium is supposed to perform. Determining the performance characteristics of culture media is necessary for commercially prepared culture media. For in-house prepared culture media the internal quality control is carried out by the user

30、. Performance criteria for culture media are necessary for obtaining comparable products of the same medium type, regardless of source. In addition these criteria may be used by all microbiology laboratories for the evaluation of nutritive and/or selective properties of (new) culture media. Uniform

31、performance criteria should therefore result in the manufacture of “standardized” products, and limit the amount of testing of commercial culture media in microbiology laboratories. 1 Scope This European Standard specifies requirements for the performance of culture media. It is concerned with the t

32、raceability, comparability, reproducibility and suitability of culture media used in microbiological laboratories. These characteristics are achieved by applying the quality criteria outlined in this standard. This European Standard is applicable to: a) commercial organizations distributing media to

33、 microbiology laboratories in ready-to-use form, as dehydrated media or as semi-finished media (see 2.5 in EN 1659:1996); b) non-commercial organizations that distribute media to satellite locations; c) laboratories that prepare culture media for their own use. Cell culture media are not covered by

34、this standard. 2 Normative references This European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendmen

35、ts to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. EN 1659:1996, In vitro diagnostic systems Culture media for microbiology Terms and

36、definitions. EN ISO 8402:1995, Quality management and quality assurance Vocabulary. (ISO 8402:1994) 3 Definitions For the purposes of this standard, the definitions given in EN 1659:1996 and in EN ISO 8402:1995 apply, together with the following. 3.1 batch of culture media; lot of culture media full

37、y traceable unit referring to a defined amount of bulk, semi-finished product or end product, which is consistent in type and quality and which has passed the requirements of production (in-process control) and quality assurance testing, and which has been produced within one defined production peri

38、od having been assigned the same lot number 3.2 control strain micro-organism used for microbial performance evaluation of culture mediaEN 12322:1999 4 BSI 24 December 2001 3.3 reference strain micro-organism defined to at least the genus and species level, catalogued and described according to its

39、characteristics 3.4 reference stock lot of containers obtained in the laboratory by a single propagation from a reference strain or multiple containers from the same lot of a reference strain from a supplier 3.5 stock culture subculture(s) of a reference stock 3.6 working culture subculture of a sto

40、ck culture 4 Performance evaluation 4.1 General quality criteria NOTE This standard is not intended to give a detailed description of quality management practices for manufacturing of culture media, which are described elsewhere (see Annex B, l to 7, 11 and 13). It should be noted that, according to

41、 some quality systems in use by manufacturers (e.g. according to EN ISO 9001 and EN 46001 or EN ISO 9002 and EN 46002), besides microbiological performance evaluation of culture media, performance testing shall also include testing of physical and chemical properties (see Annex B, 13), such as: a) q

42、uantity filled; b) layer thickness and filling format; c) colour; d) clarity and/or optical artifacts; e) homogeneity; f) gel stability and consistency; g) moisture content or homogeneity of dehydrated media; h) appearance of specific media (e.g. blood agar); i) pH value. The quality of culture medi

43、a depends on the quality of the basic ingredients, correct formulation and accuracy in preparation, adequate removal of microbial contaminants, proper packaging and storage. Raw materials, nutritive or inhibitory supplements or miniaturized test systems for identification of micro-organisms should b

44、e supplied according to the same appropriate quality procedures. 4.2 Control strains The set of control strains shall include reference strains. NOTE 1 Reference strains can be obtained from service or reference collections affiliated to ECCO or WFCC (see Annex B, 9 and 15). The set of control strai

45、ns can include well characterized positive (sensitive, resp. well-growing), weakly positive (weakly sensitive, resp. poor-growing), and negative (insensitive, resp. suppressed or inhibited) control strains (see Annex B, 5, as well as DIN 58959-6 and DIN 58959-7). Control strains for commonly used cu

46、lture media are referenced by a number of sources (see Annex B 2 to 6, 9, 11 and 12, and DIN 58959-6, DIN 58959-6 suppl. 1, DIN 58959-7 and DIN 59959-9) and may be selected as appropriate. For traceability, all control strains should be available from a reference collection. Working cultures shall b

47、e used once only. Subcultures from working cultures shall not be used for performance testing purposes or production of stock cultures. NOTE 2 For information on preservation, maintenance techniques and service culture collections, see Annex A and Annex B, 8.EN 12322:1999 BSI 24 December 2001 5 4.3

48、Microbiological quality criteria 4.3.1 Routine quality control 4.3.1.1 Growth 4.3.1.1.1 General For the lot-control of culture media and nutritive ingredients for culture media, as appropriate, growth shall be assessed: either semi-quantitatively; or quantitatively. Quantitative and semi-quantitativ

49、e evaluations shall be performed by a validated technique (see Annex B, 16). NOTE Semi-quantitative evaluations can be performed by assigned growth-scores, e.g. 0 to 3+. When reading solid media, 0 corresponds to no growth, 1+ to very poor growth ( 10 colonies), 2+ to heavy growth (single colonies) and 3+ to very heavy growth (confluent colonies). When reading fluid or semi-solid media visually, 0 represents no turbidity, 1+ faint turbidity and 2+ heavy turbidity. 4.3.1.1.2 Growth-promoting