1、DEUTSCHE NORM Ocotber 1999 I DIN development and analysis - I Biotechnology - Laboratories for research, I EN 12741 Guidance for biotechnology laboratory operations English version of DIN EN 12741 ICs 07.080; 07.1 00.01 Biotechnik - Laboratorien fr Forschung, Entwicklung und Analyse - Leitfaden fr b
2、iotechnologische Laborpraxis European Standard EN 12741 : 1999 has the status of a DIN Standard. National foreword This standard has been prepared by CEN/TC 233. The responsible German body involved in its preparation was the Normenausschu Medizin (Medical Stand- ards Committee). EN comprises 15 pag
3、es. No pari of this standard may be reproduced without the prior permission of Ref. No. DIN EN 12741 : 1999-1 Y Deutsches Institut fr Normung e. V., Berlin. wth Verlag GmbH, D-10772 Berlin, has the exclusive right of sale for German Standards (DIN-Normen). English price group O9 . Sales No. 1109 03.
4、00 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 12741 July 1999 ICs 07.080; 07.1 00.01 English version Biotechnology - Laboratories for research, development and analysis Guidance for biotechnology laboratory operations Biotechnologie - Laboratoires de recherche, dveloppement et ana- lyse -
5、Guide pour les oprations de laboratoires biotechnologiques Laborpraxis Biotechnik - Laboratorien fr For- schung, Entwicklung und Analyse - Leitfaden fr biotechnologische This European Standard was approved by CEN on 1999-06-1 9. CEN members are bound to comply with the CENKENELEC Internal Regulation
6、s 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 stand- ards may be obtained on application to the Central Secretariat or to any CEN member. The Europe
7、an Standards exist 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 Central Secretariat has the same status as the official versions. CEN members are the nation
8、al standards bodies of Austria, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and the United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisatio
9、n Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels O 1999. CEN - All rights of exploitation in any form and by any means reserved worldwide for CEN national members. Ref. No. EN 12741 : 1999 E Page 2 EN 12741 : 1999 Contents Page Foreword 3 Introduction 4 1 Sco
10、pe . 4 2 Normative references . 4 3 Definitions . 5 4 Basic practices for biotechnology laboratories . 5 5 Practices for handling microorganisms in particular containment levels . 8 6 Waste and effluent disposal 10 7 Health and medical surveillance 10 8 Management of laboratory accidents 10 9 Cleani
11、ng and maintenance 11 1 O Decontamination . 12 Annex A (informative) Guidance on the use of isolators . 13 Annex B (informative) Bibliography 15 Page 3 EN 12741 : 1999 Foreword This European Standard has been prepared by Technical Committee CEN/TC 233 “Biotechnology“, the secretariat of which is hel
12、d by AFNOR. This European Standard shall be given the status of a national 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
13、Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and
14、the United Kingdom. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association. Users of this European Standard, prepared in the field of application of Article 1 18A of the EC Treaty, should be aware that standards have n
15、o formal legal relationship with Directives which may have been made under Article 1 18A of the Treaty. In addition, national legislation in the Member states may contain more stringent requirements than the minimum requirements of a Directive based on Article 11 8A. Information on the relationship
16、between the national legislation implementing Directives based on Article 11 8A and this European Standard may be given in a national foreword of the national standard implementing the European Standard. Page 4 EN 12741 : 1999 Introduction Good biotechnology laboratory practice covers all aspects of
17、 the organization of biotechnology work and the conditions under which it is planned, executed, validated and supervised as well as aspects relating to education and training of personnel. It is recognized that good biotechnology laboratory practice requires suitable education and training of person
18、nel and the standard is written on the basis that staff have received appropriate training. Staff should have access to relevant sources of information, including the results of biological risk assessment which determines the safe working procedures and practices in a given situation. A non-exclusiv
19、e sample of relevant literature is given in annex B. There are many other texts relevant to specific items of biotechnology laboratory operations which are not quoted. 1 Scope This European Standard gives guidance for practice for biotechnology operations in research, development and analysis labora
20、tories of containment levels 1, 2, 3 and 4 (see EN 121 28 and EN 12738). This European Standard aims at the protection of workers from biological hazards as well as the environment including plants and animals. 2 Normative references This European Standard incorporates by dated or undated reference,
21、 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
22、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
23、EN 12347 Biotechnology - Performance criteria for steam sterilizers and autoclaves prEN 12469 Biotechnology - Performance criteria for microbiological safety cabinets EN 12738 Biotechnology - Laboratories for research, development and analysis - Guidance for containment of animals inoculated with mi
24、croorganisms in experiments EN 12740 Biotechnology - Laboratories for research, development and analysis - Guidance for handling, inactivating and testing of waste CR 12739 Biotechnology - Laboratories for research, development and analysis - Report on the selection of equipment needed for biotechno
25、logy laboratories according to the degree of hazard IS0 3864 Safety colours and safety signs Page 5 EN 12741 : 1999 IS0 7000 Graphical symbols for use on equipment - Index and synopsis 3 Definitions For the purposes of this standard, the following definitions apply : 3.1 hazard Intrinsic potential p
26、roperty or ability of something (e.g. any agent, equipment, material or process) to cause harm EN 16201. NOTE : Harm is an injury or damage to health of people and/or the environment. 3.2 laboratory suite One or more laboratories within a building, not necessarily of the same discipline or containme
27、nt level, with ancillary rooms and with shared use of facilities EN 121281. 3.3 microorganism Any microbiological entity, cellular or non cellular, capable of replication or of transferring genetic material EN 161 91. NOTE : For the purposes of this standard, the term microorganism covers the term o
28、f biological agent, according to the Directive 90/679/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. 3.4 risk Probability of occurrence of a hazard causing harm and the
29、 degree of severity of the harm. 4 4.1 General Basic practices for biotechnology laboratories All staff should be informed that good practice is fundamental to safety. Practices that could transfer hazardous material to mouth or skin should be avoided. Food and drink (other than samples submitted fo
30、r scientific investigation) should not be taken into, consumed or stored in any area where organisms are handled. Smoking, the use of personal medications or the application of cosmetics should not be permitted in these areas. Personnel should respect elementary rules of hygiene, should wash their h
31、ands when beginning work, whenever they have handled hazardous materials and on leaving the laboratory, after protective clothing has been removed. Hand drying should be carried out Page 6 EN 12741 : 1999 using disposable towels or other suitable materials. Disinfection and cleaning should be carrie
32、d out as necessary. Hazards involved in operating laboratory equipment include long hair, jewellery, certain types of footwear and loose clothing that may be a factor in laboratory accidents. Therefore proper attire including protective clothing appropriate for the hazard should be worn at all times
33、. Mouth pipetting should be expressly forbidden. Pipetting devices should always be used for pipetting. Aerosol release into the workplace should be minimized. If hazardous aerosols are likely to be generated, the work should be carried out in a microbiological safety cabinet (see prEN 1 2469). NOTE
34、 : Open-fronted cabinets (Class I and Il) allow some escape of airborne material. Inward airflow may be disturbed by, for example, people passing behind the operator, turbulence of air around equipment within the cabinet or sudden changes in air pressure within the room. Disturbances of this kind ma
35、y reduce the validity of operator protection and validation of operator safety may be required in specific cases. The laboratory should be tidy and clean and should not contain anything that is not related to the work. Working surfaces, including those of biological safety cabinets, should be decont
36、aminated using a validated procedure whenever biological material is accidentally spilled, when an item of work has been completed and at the end of the working day (see clause 10). The wearing of laboratory coats and/or appropriate special clothing should be compulsory. When personnel leave the lab
37、oratory suite the protective clothing should be removed and left in the changing area. Outdoor clothing should be kept separate from the working areas. When hazardous organisms are, or may be, present in laboratory suites, care should be taken to avoid distributing hazardous material from one unit t
38、o another. In some work areas or while certain operations are being carried out, it may be necessary to ensure that adequate measures exist for contacting workers. A suitable control policy for insects and rodents should be implemented (see EN 12128). The use of hypodermic needles and other sharps s
39、hould be minimized and where possible, avoided. Every worker handling them should develop a safe routine for their use, transport and disposal. All items of equipment within the laboratory should conform to the requirements of appropriate European Standards (for example, see EN 12347, prEN 12469 and
40、 CR 12739). Equipment should be selected on the basis of the possibility of decontamination and of prevention or minimization of internal contamination. The maintenance and repair of equipment and apparatus should only be undertaken by personnel with appropriate experience, who should be issued with
41、 a permit to work and who should be made aware of the possibility of contamination with hazardous organisms. Equipment should be positioned so that it is stable and not prone to tipping. Minor incidents, for example, spillage of small volumes of culture medium containing hazardous material, should b
42、e dealt with effectively e.g. by covering the affected area and equipment with swabs of disinfectant. Disposable gloves should be worn during this operation; contaminated clothing should be discarded and autoclaved. Broken glass should Page 7 EN 12741 : 1999 be swept carefully into a suitable contai
43、ner; all contaminated items of debris and equipment used to collect it should be decontaminated by a validated procedure. Action in the event of accidents and emergencies is considered in clause 8. All material contaminated with hazardous material should be decontaminated. If this is done away from
44、the laboratory, the material should be transferred in a durable, leakproof, closed container. The person in charge of the laboratory should be informed immediately of any accident. 4.2 Instruction and training Personnel should receive appropriate training for the work that is required of them. Infor
45、mation about safety measures should form an integral part of the induction training of new workers in laboratories. It is important to ensure that the basis of these safety measures is well understood in order to prevent human error and incorrect practices. Initial training should be supplemented by
46、 refresher or continuous training so as to keep up with developments in techniques and equipment. The role of heads of laboratories and of management in training the personnel for which they are responsible should be defined. The person or persons in charge of safety should take part in any in-house
47、 personnel teaching or training and preparation of training material. It is desirable that they should be familiar with laboratory work and the techniques for handling relevant potentially harmful organisms. A copy of safety instructions should always be available in working areas. 4.3 Hazard manage
48、ment The work practices of personnel should be designed to ensure safety in respect of general, physical, chemical and microbiological hazards. Personnel should be instructed and trained in methods to cope with general hazards and they should be informed and instructed of the terms of local and nati
49、onal requirements. NOTE 1 : Methods for controlling the hazards of handling hazardous material should, in most instances, be also sufficient to prevent the hazard of toxicity or allergy. However, such specific hazard may exist in other operations where pathogenicity is not an issue. In such situations attention to appropriate hygiene conditions should be given. Specific protective clothing and equipment to guard against allergy hazards may be appropriate in some instances. Medical screening may also be appropriate. Biotechnological work may involve the use of hazardous che
