1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12738:1999 The Euro
2、pean Standard EN 12738:1999 has the status of a British Standard ICS 07.080; 07.100.01 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Biotechnology Laboratories for research, development and analysis Guidance for containment of animals inoculated with microorganisms in experi
3、mentsThis British Standard, having been prepared under the direction of the Sector Committee for Materials and Chemicals, was published under the authority of the Standards Committee and comes into effect on 15 November 1999 BSI 11-1999 ISBN 0 580 32817 1 BS EN 12738:1999 Amendments issued since pub
4、lication Amd. No. Date Comments National foreword This British Standard is the English language version of EN 12738:1999. The UK participation in its preparation was entrusted to Technical Committee CII/58, Biotechnology, which has the responsibility to: aid enquirers to understand the text; present
5、 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 be obtained on req
6、uest 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 Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of
7、the BSI Standards Electronic Catalogue. A British Standard does 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. S
8、ummary 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 the document was last issued.CEN European Committee for Standardization Comite Euro
9、pe en de Normalisation Europa isches Komitee fu r 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. EN 12738:1999 E EUROPEAN STANDARD EN 12738 NORME EUROPE ENNE EUROP
10、A ISCHE NORM July 1999 ICS 07.080; 07.100.01 English version Biotechnology Laboratories for research, development and analysis Guidance for containment of animals inoculated with microorganisms in experiments Biotechnologie Laboratoires de recherche, de veloppement et analyse Guide pour le confineme
11、nt des animaux inocule s avec des microorganismes utilise sa des fins expe rimentales Biotechnik Laboratorien fu r Forschung, Entwicklung und Analyse Leitfaden fu r die Einschlieung von Tieren, die im Rahmen von Experimenten mit Mikroorganismen beimpft werden This European Standard was approved by C
12、EN on 19 June 1999. 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 bibliographical references concerning such national standards
13、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 notified to the C
14、entral 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 and United Kin
15、gdom.Page 2 EN 12738:1999 BSI 11-1999 Foreword This European Standard has been prepared by Technical Committee CEN/TC 233, Biotechnology, the Secretariat of which is held by AFNOR. This European Standard shall be given the status of a national standard, either by publication of an identical text or
16、by endorsement, at the latest by January 2000, and conflicting national standards shall be withdrawn at the latest by January 2000. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austri
17、a, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. This European Standard has been prepared under a mandate given to CEN by the European Commission and the Europ
18、ean Free Trade Association. Contents Page Foreword 2 Introduction 3 1 Scope 3 2 Normative references 3 3 Definitions 3 4 Classification, animal containment levels (ACL) 4 5 Animal containment level 1 (ACL1) 4 6 Animal containment level 2 (ACL2) 5 7 Animal containment level 3 (ACL3) 6 8 Animal contai
19、nment level 4 (ACL4) 6 Annex A (informative) Bibliography 8Page 3 EN 12738:1999 BSI 11-1999 Introduction The physical containment of 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
20、the environment which may be caused by housing and experimenting with animals. These principles are a pre-requisite for the setting up and continued operation of an animal containment facility. Those who use animals for experimental purposes have a moral obligation to avoid causing unnecessary pain
21、or suffering. NOTE Attention is drawn to existing European (see annexA1, 2) and national regulations and codes of practice relating to 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
22、protect the worker and/or the environment, gives guidance on minimum physical biosafety measures for the containment of animals deliberately inoculated with microorganisms, including genetically modified microorganisms, which can present a risk to human or animal health or the environment. This Euro
23、pean Standard does not apply to the containment of animals which have not been deliberately inoculated with microorganisms. The containment level required is determined by assessment of the risk to humans and the environment (see annex A 3, 4). The European Standard does not address procedures or pr
24、actices which are necessary for safe working with animals unless of particular relevance to the containment of animals, nor does it address requirements which are not primarily concerned with biological safety. 2 Normative references This European Standard incorporates by dated or undated reference,
25、 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 amendments to or revisions of any of these publications apply to this European Standard only when incorporated i
26、n it by amendment or revision. For undated references the latest edition of the publication referred to applies. EN 12128, Biotechnology Laboratories for research, development and analysis Containment levels of microbiology laboratories, areas of risk, localities and physical safety requirements. EN
27、 12347, Biotechnology Performance criteria for steam sterilizers and autoclaves. prEN 12469, Biotechnology Performance criteria for microbiological safety cabinets. CR 12739, Biotechnology Laboratories for research, development and analysis Report on the selection of equipment needed for biotechnolo
28、gy laboratories according to the degree of hazard. EN 12740, Biotechnology Laboratories for research, development and analysis Guidance for handling, inactivating and testing of waste. EN 12741, Biotechnology Laboratories for research, development and analysis Guidance for biotechnology laboratory o
29、perations. CR 12894, Biotechnology Microorganisms Examination of the various existing lists of animal pathogens and production of a report. EN 61010-2-041, Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-041: Particular requirements for autoclaves usin
30、g steam for the treatment of medical materials and for laboratory processes. IEC 61010-2-041:1996 EN 61010-2-042, Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-042: Particular requirements for autoclaves and sterilizers using toxic gas for the treatm
31、ent of medical materials and for laboratory processes. IEC 61010-2-042:1997 EN 61010-2-043, Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-043: Particular requirements for dry heat sterilizers using either hot air or hot inert gas for the treatment of
32、 medical materials and for laboratory processes. IEC 61010-2-043:1997 ISO 3864, Safety colours and safety signs. ISO 7000, Graphical symbols for use on equipment Index and synopsis. 3 Definitions For the purposes of this standard, the following definitions apply. 3.1 animal non-human vertebrate or i
33、nvertebrate, including free-living larval forms 3.2 animal containment level standard of accommodation suitable for the containment of animals deliberately inoculated with microorganisms 3.3 animal unit building, or separate area within a building, for the housing of animals, which may contain facil
34、ities and other areas such as changing rooms, showers, autoclaves, food storage areasPage 4 EN 12738:1999 BSI 11-1999 3.4 autoclave apparatus designed to make materials and/or equipment sterile by exposure to steam at a pressure above the atmospheric pressure EN 12347 3.5 genetically modified microo
35、rganism microorganism in which the genetic material has been altered in a way that does not occur 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 it
36、s appropriate annexes (see annex A 3). 3.6 microorganism any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material EN 1619 NOTE For the purpose of this standard, the term microorganism covers the term biological agent, according to the Directive
37、 901679/EEC: microorganisms, including those which have been genetically modified, cell cultures 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 defined spa
38、ce EN 1620 3.8 risk probability of occurrence of a hazard causing harm and the degree of severity of 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.
39、 ACL1 is the lowest level and ACL4 the highest level of containment. It is recognized that other factors 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, in
40、fectivity and virulence, path of transmission (see CR 12894) and whether and by what route they may be excreted. With respect to animals they include the size and nature of the animals (aggressiveness, tendency to bite or scratch), their natural ecto- and endoparasites, the zoonotic diseases to whic
41、h they are susceptible, or whether they are genetically modified. Methods of inoculation, sample taking, anaesthesia and post-mortems need to be considered. The recommendations for each animal containment level are as given in clause 5 to clause 8 and are summarized in Table 1. The containment measu
42、res of a higher level include those of the lower level(s). NOTE 1 Assignment of a particular containment level depends on the objectives of protection (i.e. against hazards to humans, plants, animals or the environment). The foot and mouth virus may, for example, require handling in ACL4 if animal p
43、rotection 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 select and combine animal containment recommendations on the basis of risk assessment. The physical containment measures should be applied a
44、ccording 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 recommendations for containment of microorganisms in laboratories (see EN 12128) are applicable and/or can be combined with the guidance given in this Eur
45、opean 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 take additional containment measures not mentioned in this standard. This could for example be the case when carrying out autopsies on infec
46、ted animals requiring the higher containment levels. An emergency plan to be used when existing containment fails should be developed and be available at all times. 5 Animal containment level 1 (ACL1) 5.1 General In general, ACL1 provides conditions which are suitable for the maintenance of animals
47、according to European regulations concerning health and welfare of animals (annex A 1, 2) and few additional features are required for reasons of biosafety. 5.2 Animal unit design and construction Drains and any other services that enter through the walls or floor should prevent the ingress of roden
48、ts 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 out safely. In determining the amount of space required consideration should be given to the nature of the work, species and maturity of a
49、nimal 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 unit. 5.3 Specific containment measures 5.3.1 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-ino
