1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12741:1999 The Euro
2、pean Standard EN 12741:1999 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 biotechnology laboratory operationsThis British Standard, havin
3、g 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 32819 8 BS EN 12741:1999 Amendments issued since publication Amd. No. Date Comments N
4、ational foreword This British Standard is the English language version of EN 12741:1999. 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 to the responsible European comm
5、ittee 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 request to its secretary. Cross-refe
6、rences 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 the BSI Standards Electronic Cata
7、logue. 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. Summary of pages This document com
8、prises a front cover, an inside front cover, the EN title page, pages 2 to 9 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 Europe en de Normalisation Europa isches Komitee fu r Normu
9、ng 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 12741:1999 E EUROPEAN STANDARD EN 12741 NORME EUROPE ENNE EUROPA ISCHE NORM July 1999 ICS 07.080; 07.100.01 English ve
10、rsion Biotechnology Laboratories for research, development and analysis Guidance for biotechnology laboratory operations Biotechnologie Laboratoires de recherche, de veloppement et analyse Guide pour les ope rations de laboratoires biotechnologiques Biotechnik Laboratorien fu r Forschung, Entwicklun
11、g und Analyse Leitfaden fu r biotechnologische Laborpraxis This European Standard was approved by CEN 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
12、any alteration. Up-to-date lists and bibliographical 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
13、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 national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, I
14、reland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.Page 2 EN 12741:1999 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 Standa
15、rd 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 CEN/CENELEC Internal Regulations, the national stand
16、ards 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 the United Kingdom. This Europe
17、an 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 118A of the EC Treaty, should be aware that standards have no formal legal relationship with
18、 Directives which may have been made under Article 118A 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 118A. Information on the relationship between the national legislation
19、implementing Directives based on Article 118A and this European Standard may be given in a national foreword of the national standard implementing the European Standard. Contents Page Foreword 2 Introduction 3 1 Scope 3 2 Normative references 3 3 Definitions 3 4 Basic practices for biotechnology lab
20、oratories 4 5 Practices for handling microorganisms, in particular containment levels 5 6 Waste and effluent disposal 6 7 Health and medical surveillance 6 8 Management of laboratory accidents 6 9 Cleaning and maintenance 7 10 Decontamination 7 Annex A (informative) Guidance on the use of isolators
21、8 Annex B (informative) Bibliography 9Page 3 EN 12741:1999 BSI 11-1999 Introduction Good biotechnology laboratory practice covers all aspects of the organization of biotechnology work and the conditions under which it is planned, executed, validated and supervised, as well as aspects relating to edu
22、cation and training of personnel. It is recognized that good biotechnology laboratory practice requires suitable education and training of personnel, and the standard is written on the basis that staff have received appropriate training. Staff should have access to relevant sources of information, i
23、ncluding the results of biological risk assessment which determines the safe working procedures and practices in a given situation. A non-exclusive sample of relevant literature is given in annex B. There are many other texts relevant to specific items of biotechnology laboratory operations which ar
24、e not quoted. 1 Scope This European Standard gives guidance for practice for biotechnology operations in research, development and analysis laboratories of containment levels 1, 2, 3 and 4 (see EN 12128 and EN 12738). This European Standard aims at the protection of workers from biological hazards a
25、s well as the environment, including plants and animals. 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.
26、 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 undated references the latest edition of the publication referred to applies. EN 12128, Biotechnology Laboratories for
27、research, development and analysis Containment levels of microbiology laboratories, areas of risk, localities and physical safety requirements. EN 12347, Biotechnology Performance criteria for steam sterilizers and autoclaves. prEN 12469, Biotechnology Performance criteria for microbiological safety
28、 cabinets. EN 12738, Biotechnology Laboratories for research, development and analysis Guidance for containment of animals inoculated with microorganisms in experiments. EN 12740, Biotechnology Laboratories for research, development and analysis Guidance for handling, inactivating and testing of was
29、te. CR 12739, Biotechnology Laboratories for research, development and analysis Report on the selection of equipment needed for biotechnology laboratories according to the degree of hazard. ISO 3864, Safety colours and safety signs. ISO 7000, Graphical symbols for use on equipment Index and synopsis
30、. 3 Definitions For the purposes of this standard, the following definitions apply. 3.1 hazard intrinsic potential property or ability of something (e.g. any agent, equipment, material or process) to cause harm EN 1620 NOTE Harm is an injury or damage to health of people and/or the environment. 3.2
31、laboratory suite one or more laboratories within a building, not necessarily of the same discipline or containment level, with ancillary rooms and with shared use of facilities EN 12128 3.3 microorganism any microbiological entity, cellular or non-cellular, capable of replication or of transferring
32、genetic material EN 1619 NOTE For the purposes of this standard, the term microorganism covers the term of 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
33、 any infection, allergy or toxicity. 3.4 risk probability of occurrence of a hazard causing harm and the degree of severity of the harmPage 4 EN 12741:1999 BSI 11-1999 4 Basic practices for biotechnology laboratories 4.1 General All staff should be informed that good practice is fundamental to safet
34、y. Practices that could transfer hazardous material to mouth or skin should be avoided. Food and drink (other than samples submitted for 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 app
35、lication of cosmetics should not be permitted in these areas. Personnel should respect elementary rules of hygiene, should wash their hands when beginning work, whenever they have handled hazardous materials and on leaving the laboratory, after protective clothing has been removed. Hand drying shoul
36、d be carried out using disposable towels or other suitable materials. Disinfection and cleaning should be carried 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 acciden
37、ts. Therefore proper attire including protective clothing appropriate for the hazard should be worn at all times. 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 li
38、kely to be generated, the work should be carried out in a microbiological safety cabinet (see prEN 12469). NOTE Open-fronted cabinets (class I and II) allow some escape of airborne material. Inward airflow may be disturbed by, for example, people passing behind the operator, turbulence of air around
39、 equipment within the cabinet or sudden changes in air pressure within the room. Disturbances of this kind may 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
40、is not related to the work. Working surfaces, including those of biological safety cabinets, should be decontaminated 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 weari
41、ng of laboratory coats and/or appropriate special clothing should be compulsory. When personnel leave the laboratory 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 b
42、e, present in laboratory suites, care should be taken to avoid distributing hazardous material from one unit to 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
43、for insects and rodents should be implemented (see EN 12128). The use of hypodermic needles and other sharp instruments should 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
44、laboratory should conform to the requirements of appropriate European Standards (for example, see EN 12347, prEN 12469 and 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 repai
45、r of equipment and apparatus should only be undertaken by personnel with appropriate experience, who should be issued with 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
46、tipping. Minor incidents, for example, spillage of small volumes of culture medium containing hazardous material, should be 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 clothi
47、ng should be discarded and autoclaved. Broken glass should be swept carefully into a suitable container; 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. Al
48、l material contaminated with hazardous material should be decontaminated. If this is done away from 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
49、 training Personnel should receive appropriate training for the work that is required of them. Information 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 refresher or continuous training so as to keep up with developments in techniques and equipment. The role of heads of lab
