EN 12738-1999 en Biotechnology - Laboratories for Research Development and Analysis - Guidance for Containment of Animals inoculated with Microorganisms in Experiments《生物技术 研究 开发和分.pdf

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1、STD.BSI BS EN L2738-ENGL 1999 Lb24bb OBL3000 973 BRITISH STANDARD Biotechnology - Laboratories for research, development and analysis - Guidance for containment of animals inoculated with microorganisms in experiments The European Standard EN 127381999 has the status of a British Standard ICs 07.080

2、 07.100.01 3s EN 12738: 1999 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW - - STDmBSI BS EN L2738-ENGL 3999 9 bb24bb9 08L300L 83T BS EN 127381999 been prepared under the direction of the Sector Amd.No. Date Committee for Materiais and Chemicals, was published under the auth

3、ority of the Standards Committee and comes into effect on 15 November 1999 O BSI 11-1999 ISBN O 580 32817 1 National foreword Comments This British Standard is the English language version of EN 12738: 1999. The UK participation in its preparation was entrusted to Technical Committee CIV58, Biotechn

4、ology, which has the responsibility to: - aid enquire= to understand the text, - present to the responsible European committee any enquiries on the - monitor related international and European developments and promulgate interpretation, or proposals for change, and keep the UK interests informed; th

5、em in the UK. A list of orgamizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standasds Catalogue under the section en

6、tited “Intedonal Standards Correspondence Index”, or by using the “Find” faciiity of the BSI Standards Electronic Cataogue. A British Standard does not purport to include ai the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance w

7、ith 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 page, pages 2 to 8, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when

8、the document was last issued. STD-BSI BS EN 32738-ENGL 1999 Lb24bb9 0833002 77b EUROPEAN STANDARD EN 12738 NORME EUR0pEE“E EUROP- NORM July 1999 ICs 07.080 07.100.01 Ehghsh version Biotechnology- Laboratories for research, development and analysis- Guidance for contaanment of animals in- with rnicro

9、org- in experiments E3iotchnologie - Laboratoires de recherche, dveloppement et analyse - Guide pour le connement des animam inoculs avec des micmrganisms utiliss des fhs exprimentales Biotechnik - Laboratorien fur Forschung, Entwicklung und Analyse - Leithden fr die EinscNieBung von Tieren, die im

10、Rahmen von Expenmenten mit Mikroorganismen beimpt werden This European Standard was approved by CEN on 19 June 1999. CEN members are bound to comply with the CENICENELEC internai Regulations which stipulate the conditions for giving this European Standard the status of a national standard without an

11、y aitenition. Upto-date lists and bibliographical references conceming such national standards may be obtained on application to the Centrai Secretariat or to any CEN member. This European Standard exists in three offcial versions (Enghsh, French, German). A version in any other language made by tra

12、nslation under the responsibility of a CEN member into its own language and notified to the Centrai Secretariat has the same stanis as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, Rance, Germany, Greece, Iceland, Ireland,

13、 Italy, Luxembourg, Netherlands, Norway, 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-1060 Brussels O 1999 CEN Ail rights of exploitation in

14、 any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 12738:1!3!39 E Page 2 EN 127381999 Foreword STD-BSI BS EN L2736-ENGL 1999 1b24bb9 0813003 b02 = This European standard has been prepared by kchnical Committee CEN/rC 233, Biotechnology, the Secretariat of which is he

15、ld by AFNOR. This European Standard shall be given the status of a nationai standard, either by publication of an identical text or by endorsement, at the latest by January 2000, and conflicting national standards shall be withdrawn at the latest by January 2000. According to the CENKENELEC Internal

16、 Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, Frcuice, Gems Greece, Iceland, Ireland, Ita& Luxembourg, Netherlands, Norwas Portugal, Spain, Sweden, Switzerland and the U

17、nited Kingdom. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association. Contents Foreword Introduction 1 Scope 2 Normative references 3 Definitions 4 Classification, animal containment levels (ACL) 5 Animal containment

18、level 1 (ACLl) 6 Animal containment level 2 (ACL2) 7 Animal containment level 3 (ACL3) 8 Animal containment level 4 (ACL4) Annex A (informative) Bibliography page 2 3 3 3 3 O BSI 11-1999 STD-BSI BS EN 12738-ENGL 1997 1b24bb9 0813004 549 6 Page 3 EN 12738:1999 Introduction The physical containment of

19、 inoculated animals for reasons of biological safety is based on the principles of the prevention and control of microbiological hazards to humans, animals, plants and the environment which may be caused by housing and experimenting with animals. These principles are a prerequisite for the setting u

20、p and continued operation of an animal containment faciity. Those who use animais for experimental purposes have a moral obligation to avoid causing unnecessary pain or suffering. NOTE Attention is drawn to existing European (see annexAl, 2) and national regulations and codes of practice relating to

21、 the protection of animals used for experimental and other scientific purposes and to the management of infected animals. 1 scope This European Standard, in order to protect the worker andor the environment, gives guidance on minimum physical biosafety measures for the containment of animals deliber

22、ately inoculated with microorganisms, including genetically modified microorganisms, which can present a risk to human or animai health or the environment. This European Standard does not apply to the containment of animals which have not been deliberately inoculated with microorganisms. The contain

23、ment level required is determined by assessment of the risk to humans and the environment (see annex A 3, 4). The European standard does not adres procedures or practices which are necessary for safe working with animals unless of particular relevance to the containment of animals, nor does it adres

24、s requirements which are not primariiy concerned with biological safety 2 Normative references This European Standard incorporates by dated or undated reference, provisions from other publications. These nonnative references are cited at the appropriate places in the text and the publications are li

25、sted hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For unakd references the latest edition of the publication referred to applies. EN 12128, Biotechnology - La

26、bomtoriRs for research, deveEopment and analysis - Containmmt levels of microbiology laboratories, areas of risk, localities and physical safety requirements. EN 12347, Biotechnology - PNomnce criera for steam sterilizers and autoclaves. prEN 12469, Biotechnology - Pmrxe Cmteria for microbiological

27、safety cabinets. CR 12739, Biotechnology - LaOomtOrieS for mmmh, dmelopnent and analysis - Report on the selection of equipnent needed for botechnology iubomtories accoding to he egree of hazald. EN 12740, Biotechnology - Laborato+s for research, development and analysis - Guidance for handling, ina

28、ctivating and testing of waste. EN 12741, Biotechnology - LabomtOrieS for mmmh, development and analysis - Gu&n.ce for biotechnology labomtorg operations. CR 12894, Biotechnology - Microorganisms - Examination of he various existing lists of animal pathogens and productwn of a report. EN 61010-2-041

29、, Safety requirernents for electrical equipment for measurement, conml and laboratory use - Part 2-41: Particular requirements for autoclaves using steam for the treatment of medicai materials and for labomtov procases. IEC 61010-2-041:1!396 EN 61010-2-042, Safety requirements for electrical equipna

30、ent for measurement, control and laoratorg use- Part 2-042: Part-r requirements for autoclaves and steriE.izers using to& gas for the treatment of medical muterials and for laboratmy proCesSes. iEC 61012-O42: 19971 EN 61010-2-043, Safety requirements for electrical equipment for memmt, control and l

31、abmtorg use - Part 2-043: Particular requirements for dry heat steru.izers using either hot air or hot inert gas for the treatment of medicd mum and for laboratory processes. IEC 61010-2-043:19!97 IS0 3864, Safety colours and safety signs. IS0 7000, Graphical symbols for use on equipment - Index and

32、 synopsis. 3 Delinitions For the purposes of this standard, the following definitions apply 3.1 animal non-human vertebrate or invertebrate, including free-living larval forms 3.2 animal containment level standard of accommodation suitable for the Containment of animals deliberately inoculated with

33、microorganisms 3.3 animal unit building, or separate area within a buildmg, for the housing of animals, which may contain facilities and other areas such as changing rooms, showers, autoclaves, food storage areas O BSI 11-1999 Page 4 EN 127381999 STDmBSI BS EN L2738-ENGL L999 3.4 The recommendations

34、 for each animal containment autoclave apparatus designed to make mate- and/or equipment sterile by exposure to steam at a pressure above the atmospheric pressure EN 123471 3.6 genetically modified microorganism microorganism in which the genetic material has been altered in a way that does not occu

35、r naturally by mating and/or natural recombination NOTE Within the terms of this definition, genetic modification occurs at least through the use of the techniques listed in the Directive 90/219/EEC or its appropriate annexes (see annex A 3). 3.6 microorganism any microbiological entity, cellular or

36、 non-cellular, capable of replication or of transferring genetic material EN 16191 NOTE For the purpose of this standard, the term microorganism covers the term biological agent, according to the Directive 901679EEC microorganisms, including those which have been genetically modified, celi cultures

37、and human endoparasites which may be able to provoke any infection, allergy or toxicity 3.7 physical containment system for confining a microorganism and/or organism or other entity within a defned space EN 16201 3.8 risk probabiiiQ of occurrence of a hazard causing harm and the degree of severity o

38、f the harm 4 Classification, animal containment levels (ACL) Four levels of animal containment, namely ACL1,2,3 and 4, are based primarily on the risk group assigned to the microorganisms being used ACLl is the lowest level and ACL4 the highest level of containment. It is recognized that other facto

39、rs also influence the selection of an appropriate level of animal containment. With respect to microorganisms these factors include volume and concentrations to be used, the route of inoculation, infectiviQ and dence, path of transmission (see CR 12894) and whether and by what route they may be excr

40、eted. With respect to animais they include the size and nature of the animals (aggressiveness, tendency to bite or scratch), their natural ectu and endoparasites, the zoonotic diseases to which they are susceptible, or whether they are geneticaly modified. Methods of inoculation, sample taking, anae

41、sthesia and post-mortems need to be considered. level are as given in clause 6 to clause 8 and are summarized in Table 1. The containment measures of a higher level include those of the lower levei(s). NOTE 1 Assignment of a particular containment level depends on the objectives of protection (i.e.

42、against hazards to humanq, plants, animals or the environment). The foot and mouth vim may, for example, require handling in ACLA if animal protection is the objective, or in ACL2 if human health protection is the objective. A case by case approach is thus often appropriate. It should be possible to

43、 select and combine animal containment recommendations on the basis of risk assessment. The physical containment measures should be applied accordmg to the nature of the work, assessment of risk to workers, nature of the microorganism and species of animal involved. NOTE 2 Most of the recommendation

44、s for containment of microorganisms in laboratories (see EN 12128) are applicable and/or can be combined with the guidance given in this European Standard to obtain the most appropriate protection of workers and environment. NOTE 3 In certain cases, the nature of the work might make it necessary to

45、take additional containment measures not mentioned in this standard. This could for example be the case when canying out autopsies on infected animals requiring the higher containment levels. An emergency plan to be used when existing containment fails should be developed and be available at all tim

46、es. 5 Animal containment level 1 (ACL1) 6.1 General In general, ACLl provides conditions which are suitable for the maintenance of animals according to European reguhiions concerning health and welfare of animals (annex A i, 2) and few additional features are required for reasons of biosafety. 6.2 A

47、nimal unit design and construction Drains and any other services that enter through the walls or floor should prevent the ingress of rodents and insects. Floor to wall, wall to ceiling and wall to wall junctions should permit easy cleaning. There should be adequate floor area for work to be carried

48、out safely In determining the anount of space required consideration should be given to hie nature of the work, species and maturity of animal to be housed and include space for bench and free standing equipment (e.g. cages, isolators, etc.). Hand washing facilities should be provided in the animal

49、unit 6.3 Specific containment measures 6.3.1 General Animal species should be housed in appropriate cages, runs or pens suitable to their requirements within an animal unit, which should conform to relevant European or international standards. When appropriate, separate rooms should be provided for inoculated and non-inoculated animals. After use, cages should, where appli-Ale, be cleaned in a manner that substantially reduces contamination. O BSI 11-1999 c STDmBSI BS EN 12738-ENGL 1999 1624667 O81300b 311 W Page 6 EN 127381