EN 12322-1999 en In Vitro Diagnostic Medical Devices - Culture Media for Microbiology - Performance Criteria for Culture Media (Incorporates Amendment A1 2001)《试管诊断医疗装置 微生物用培养基 培养基.pdf

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1、BRITISH STANDARD In vitro diagnostic medical devices Culture media for i- i micro biology Performance criteria for culture media The European Standard EN 12322:1999, with the incorporation of amendment Al, has the status of a British Standard ICs 07.100.10 BS EN 12322: 1999 Incorporating Amendment N

2、o. I Wk -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 represented on this committee can b

3、e obtained on request to its secretary. The UK submitted a negative vote toprEN 12322 but the standard received an overall positive vote from CEN Member Bodies and the UKcomments were not accepted. The reasons for UK disapproval were as follows. Clause 4, Peisownance evaluation. It is not clear how

4、the requirements are to be verified, contrary to the ISO/IEC Directives Part 3:1997. Clause 4. I, General quality criteria. It is expected that manufacturers will use appropriate European and international quality systems standards in conjunction with EN 12322, so inclusion by cross reference is unn

5、ecessary. 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. Cr oss-r e fer enc e s The British Standards which implement internationa

6、l 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 not purport to include all

7、 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 front cover, the EN title

8、 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. IDate I Comments 13482 124 December 200 1 I Addition of Annex ZA O BSI 24 December 2001 IS

9、BN O 580 32698 5 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 12322 +Al April 1999 October 2001 ICs 07.100.10 English version In vitro diagnostic medical devices -Culture media for microbiology - Performance criteria for culture media (includes amendment A1:200 1) Dispositifs mdicaux de diag

10、nostic in vitro - Milleux de culture de microbiologie -Critres de performance des milieux de culture (inclut lamendement Al :200 1) In-vitro-Diagnostika - Kulturmedien fUr die Mikrobiologie - Leistungskriterien fr Kult ur medien (enthlt nderung A1:2001) This European Standard was approved by CEN on

11、16 March 1999. Amendment A1:2001 was approved by CEN on 30 September 2001. CEN members are bound to comply with the CENKENELEC 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 biograph

12、ical references concerning such national 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

13、 member into its own language and notified 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,

14、Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels O 1999 CEN -Ail rights of exploitation in any form and by any means reserved worl

15、dwide for CEN national Members. Ref No. EN 12322:1999 + A1:2001 E EN 12322:1999 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 nat

16、ional standard, either 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 E

17、uropean Free Trade Association, and supports essential requirements of EU Directive(s). Annex A and Annex B are for information only. According to the CENKENELEC Internal Regulations, the national standards organizations ofthe following countries are bound to implement this European Standard: Austri

18、a, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Foreword to amendment Al This amendment EN 12322: 1999/A1:2001 to the EN 12322:1999 has been prepared by Techn

19、ical Committee CEN/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,

20、and conflicting national 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 Direc

21、tive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this standard. According to the CENKENELEC Internal Regulations, the national standards organizations ofthe following countries are bound to implement this European Standard: Austria, Belgium, Czec

22、h Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword 2 Introduction 3 1 Scope 3 2 Normative references 3 3 Definitions 3 4 Performance evaluation 4 4.2 Cont

23、rol strains 4 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 (informative) Bibliography 8 Annex ZA (informative) Clauses of thi

24、s European Standard addressing essential requirements or 4.1 General quality criteria 4 4.3 Microbiological quality criteria 5 other provisions of EU Directives 10 2 O BSI 24 December 200 1 EN 12322: 1999 I nt r o du c t i o n In the microbiology laboratory many tests and procedures depend on cultur

25、e media being consistent and 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, th

26、e main objectives are growth and rapid and sensitive detection ofmicro-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 l), and it is of

27、 primary importance to define 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

28、is carried out by the user. 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 andor selective properties of (new

29、) culture media. Uniform 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 ofculture media. It

30、 is concerned with the traceability, 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 organizatio

31、ns distributing media to 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 m

32、edia are not covered by 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 referen

33、ces, subsequent amendments to or revisions ofany ofthese publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition ofthe publication referred to applies. EN 1659: 1996, In vitro diagnostic systems - Culture media for

34、 microbiology - Tem and de$nitions. EN IS0 8402: 1995, Quality management and quality assurance - Viabulary. (ISO8402:1994) 3 Definitions For the purposes of this standard, the definitions given in EN 1659: 1996 and in EN IS0 8402: 1995 apply, together with the following. 3.1 batch of culture media;

35、 lot of culture media fully traceable unit referring to a defined amount ofbulk, 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 on

36、e defined production period having been assigned the same lot number 3.2 control strain micro-organism used for microbial performance evaluation of culture media 3 O BSI 24 December 2001 EN 12322:1999 3.3 reference strain micro-organism defined to at least the genus and species level, catalogued and

37、 described according to its characteris tics 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 workin

38、g culture subculture of a stock culture 4 Performance evaluation 4.1 General quality criteria NOTE media, which are described elsewhere (see Annex B, i to 7, i i and 13). This standard is not intended to give a detailed description of quality management practices for manufacturing of culture It shou

39、ld be noted that, according to some quality systems in use by manufacturers (e.g. according to EN IS0 900 1 and EN 4600 1 or EN IS0 9002 and EN 46002), besides microbiological performance evaluation of culture media, performance testing shall also include testing of physical and chemical properties

40、(see Annex B, 13), such as: a) quantity filled; b) layer thickness and filling format; c) colour; d) clarity andor 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 val

41、ue. The quality of culture media 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 identificat

42、ion of micro-organisms should be supplied according to the same appropriate quality procedures. 4.2 Control strains The set of control strains shall include reference strains. NOTE 1 and i 51). The set of control strains can include well characterized positive (sensitive, resp. well-growing), weakly

43、 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 culture media are referenced by a number of sources (see AnnexB 2 to 6, 9, i i and 1

44、2, 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. Reference strains can be obtained from service or reference collections affiliated to ECCO or WFCC (see An

45、nex B, 9 Working cultures shall be 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, SI. 4 O BS

46、I 24 December 200 1 EN 12322: 1999 4.3 Microbiological quality criteria 4.3.1 Routine quality control 4.3.1.1 Growth 4.3.1.1.1 General For the lot-control ofculture media and nutritive ingredients for culture media, as appropriate, growth shall be assessed: -either semi-quantitatively; or - quantita

47、tively. Quantitative and semi-quantitative evaluations shall be performed by a validated technique (see Annex B, 16). NOTE corresponds to no growth, It to very poor growth ( 10 colonies), 2t to heavy growth (single colonies) and 3t to very heavy growth (confluent colonies). When reading fluid or sem

48、i-solid media visually, O represents no turbidity, It faint turbidity and 2t heavy turbidity. Semi-quantitative evaluations can be performed by assigned growth-scores, e.g. O to 3t. When reading solid media, O 4.3.1.1.2 Growth-promotingpropenes With an appropriate device and a defined volume of appr

49、opriate control strains, solid, semi-solid or liquid culture media shall be inoculated with an appropriate inoculum of the control strains. NOTE isolated colonies by an appropriate streaking plate technique can be appropriate. For light inocula, 100 to 1 O00 CFU (colony forming unit) for each control strain or a sufficient amount of CFU to provide 4.3.1.1.3 Growth-inhibitingpropwties For the assessment of growth-inhibiting properties of selective culture media, with an appropriate device and a defined volume, solid, semi-solid or liquid media shal