1、STD=BSI BS EN 12741-ENGL 1999 m 1b24bb9 0807b27 2T2 m BRITISH STANDARD Biotechnology - Laboratories for research, development and analysis - Guidance for biotechnology laboratory operations The European Standard EN 12741:1999 has the status of a British Standard ICs 07.080; 07.100.01 NO COPYING WITH
2、OUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BS EN 12741:1999 BS EN 12741:1999 been prepared under the Committee for Matenals and (hmirals, was published under the authonty of the Standards Committee and comes into effect on 15 November 1999 dirwtion of the Sector Amd.No. Date O BSI 11-19
3、99 I ISBN O 580 32819 8 National foreword Comments This British Standard is the English language version of EN 12741: 1999. The UK participation in its preparation was entmsted to Technical Committee CII/58, Biotechnology, which has the responsibility to: - aid enquirers to understand the text; - pr
4、esent 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
5、 on request to its secretaqy. 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” facil
6、ity of 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 obligat
7、ions. Summary of pages This document comprises 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. STD-BSI BS EN 12741-ENGL 1999 m 1b24bb9 0807b29 075 m EUROPEAN flmm
8、EN 12741 NORME EWR0PEE”E EXJROP- NOM July 1999 ICs 07.080 07.100.01 Ehghsh version Biotechnology- Laboratmies for research, development and analysis - Guidance for biotechnology laboratory operations Biotechnologie - Laboratoires de recherche, dveloppement et analyse - Guide pour les oprations de la
9、boratoires biotechnologiques Biotechnik - Laboratorien fur Fomchung, Entwicklung und Analyse - Leitfaden fur biotechnologische LaborpraJos This European Standard was approved by CEN on 19 June 1999. CEN members are bound to comply with the CEN/CENELEC internal Regulations which stipuiate the conditi
10、ons for giving this European Standard the status of a national standard without any alteration. Uptedate 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 offi
11、cial versions (English, French, German). A version in any other language made by tsansation under the responsibility of a CEN member into its own language and notified to the Centrd Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Be
12、lgium, Czech Republic, Denmark, Finland, fiance, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. European Committee for Standardization Comitk Europen de Normalisation Europisches Komitee fr Normung Central Secretari
13、at: rue de Stassart 36, B-1050 Brussels O 1999 CEN AU rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 12741:1999 E STD*BSI BS EN L274L-ENGL 1999 W Lb24bb9 0807b30 897 = Page 2 EN 12741:1999 Foreword This European Standard has been prepared
14、 by Technical Committee CENEC 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 by endorsement, at the latest by January 2000, and conflicting national standards shall
15、be withdrawn at the latest by January 2000. According to the CENKENELEC Internal 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, I
16、taly, 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 European Free We Association. Users of this European Standard, prepared in the field of applica
17、tion of Article 118A of the EC contaminated clothing should be discarded and autoclaved. Broken glass should be swept carefully into a suitable container; ail contaminated items of debris and equipment used to collect it should be decontaminated by a validated procedure. Action in the event of accid
18、ents and emergencies is considered in clause 8. AU material contaminated with hazardous material should be decontaminated. If this is done away from the laboratmy, the material should be transferred in a durable, leakproof, closed container. The person in charge of the laboratory should be informed
19、immediately of any accident. 4.2 Instruction and training Personnel should receive appropriate trainhg 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 ba
20、sis of these safety measures is well understood in order to prevent human error and incorrect practices. Initial trainhg should be supplemented by 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 t
21、raining the personnel for which they are responsible should be defined. O BSI 11-1999 STDmBSI BS EN 12341-ENGL 1999 1624bb9 0807b33 5Tb Page 5 EN 12741:1999 The person or persons in charge of safety should take part in any in-house personnel Or mg and preparation of training material. It is desirabl
22、e that they should be familiar with laboratory work and the techniques for handling relevant potentidy hannfl organisms. A copy of safety instructions should always be avaiable in working areas. 6.2 Practices in containment level 1 The basic practices given in 4.1,4.2 and 4.3 should be observed. 5.3
23、 Additional practices in containment level 2 The following should be observed, in addition to 6.2, for handling microorganisms in laboratory facilities of containment level 2. 4.3 Hazard management The work practices of personnel should be designed to ensure safety in respect of general, physical, c
24、hemical 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 national requirements. NOTE 1 Methods for conwolling the hazards of handing hazardous material should, in most
25、instances, be also sufficient to prevent the hazard of toxicity or allergy. However, such specific hazards 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
26、guard against allergy hazards may be appropriate in some instances. Medical screening may also be appropriate. Biotechnological work may involve the use of hazardous chemicals, for example mutagens, carcinogens, and teratogenic, radioactive and other toxic products. Personnel should be instructed an
27、d know how to apply relevant safety techniques. AU personnel should be instructed on safety measures relating to specific classes of pathogenic microorganisms. Procedures to be applied when using microorganisms handled in specific containment levels are listed in clause 6. EN 12738 should be consult
28、ed when animal experiments are carried out. Guidance on the use of isolators is given in annex A. NOTE 2 Attention is drawn to existing European (see annex B (lo and (li) and national regulations. 5 Practices for handling microorganisms, in particular containment levels 6.1 General Microorganisms to
29、 be used should be classified with respect to the hazard they present to humans and the environment (see annex B lo and li). The identity of the microorganisms used should be verified regularly by a competent worker. Microorganisms should be handed in appropriate laboratories of containment levels 1
30、,2,3 and 4 as indicated by risk assessment. Laboratories for research, development and analysis should be designed in accordance with EN 12128. NOTE For operations using microorganisms only pathogenic for the environment lant or some animal pathogens, e.g. foot and mouth disease virus), this Europea
31、n Standard should be adapted according to the risk for the environment and taking into account the recommendations of the national competent authorities. a) Laboratories should be clearly and prominently labelled on the outside by attaching to the doors of the laboratories biohazard warning signs co
32、nforming to IS0 7000 regarchg their graphical presentation and IS0 3864 regarding the combination of geometric form and safety colour, and indicating the containment level. “he international biohazard symbol should be also afxed on closed incubation and conservation equipment such as incubators, ref
33、rigerators or freezers, in particular when this equipment is situated outside the work area b) Access should be reshicted to authorized personnel. c) When appropriate, all contact between skin and contaminated materiais should be avoided by the wearing of gloves or oversleeves. d) The iqjection and
34、aspiration of hazardous material should be carried out with needle-locking syringes or with disposable syringe-needle units. Precautions should be taken and considerable care exercised when using syringes, in order to avoid accidental self-inoculation or the formation of aerosols. Constant attention
35、 should be paid to gestures and in particular to the position of the hand not holding the syringe. Needles should never be broken or bent by hand or be replaced in their original covers. Before their removal or reuse, used needles and other pointed or sharp-edged tools should be carefully placed in
36、containers that cannot be perforated, for disposal or decontamination by a validated method. e) It is recommended that biological material be kept or stocked in a clearly indicated safe place, which is iabeiled and exclusively accessible to authorized persons. f) When laboratory animals are delibera
37、tely contaminated by one or severai pathogenic agents, they should be handled or housed on premises that correspond to the conditions and containment levels required according to the classification of the microorganism(s) used. NOTE 1 Appropriate measures for the containment, of animais in experimen
38、ts are given in EN 12738. 0 BSI 11-1999 STDaBSI BS EN L274L-ENGL 1997 lbZ4hb9 O807634 432 = Page 6 EN 12741:1999 g) Waste or materials to be decontaminated should be placed on a far-ff site in correctly labelled leakproof resistant containers. NOTE 2 Guidance relating to methods for the removal of w
39、aste emanating from installations for research, development and analysis is given in EN 12740. h) Equipment that is likely to be contaminated, such as microbiological safety cabinets or centrifuges, should be decontaminated before being taken out of the laboratory. i) Animais or plants that are not
40、involved in experiments should not be admitted to the laboratory. 6.4 Additional practices in containment level 3 The following should be observed, in addition to 6.2 and 6.3, for handling microorganisms in laboratory facilities of containment level 3. a) Fastened gowns, gloves, laboratory shoes and
41、 safety glasses should be worn. Whenever it is necessary, appropriate additional personal protective equipment should be used, such as oversleeves, masks, visors, ventilated cagoules, breathuig masks, face shields. b) All liquid or solid waste and contaminated materials, whatever their volume, shoul
42、d be decontaminated before leaving the laboratory; in the exceptional case of the autoclave being situated close to the laboratory, appropriate vaidated procedures, which are checked when put into practice, should be applied, in order to allow the tsancfer of waste and contaminated materials to this
43、 autoclave. This process involves the use of leakproof containers, which are externally decontaminated in a material airlock before being rapidly transferred to the autoclave for sterilization by an authorized person. c) The tsancfer of live biological material coming from a containment level 3 labo
44、ratory should be carried out according to a defined procedure, in leakproof resistant containers (see EN 12740). d) Laboratory clothes should be decontaminated before being cleaned, additional personal protective equipment should be taken off before leaving the laboratory and decontaminated before r
45、euse or removal. 6.6 Additional practices in containment level 4 For handling of microorganisms in laboratory facilities of containment level 4, special safety measures should be set casebycase in agreement with national competent authorities. The following should be observed as a minimum, in additi
46、on to 6.2,6.3, and 6.4. a) Access should be restricted to authorized workers, only through the airlock. b) A complete change of clothing including undergarments should be performed in the controlled area The clothing should be removed after work in the dirty side of the changing area and placed in a
47、 container for autoclaving. A shower should be taken before leaving the workplace. c) Appropriate respiratory protective equipment in sufficient quantity should be available. 6 Waste and effluent disposal Safe waste and effluent disposal is an integral part of the operation of a biotechnology labora
48、tory. NOTE EN 12740. Guidance on methods of waste disposai is given in 7 Health and medical surveillance The health of employees handling hazardous biological materials should be regularly checked; health surveillance examinations should be canied out before the work is started and at regular, speci
49、fied intervals thereafter. For occupational health surveillance, generally accepted national guidelinesllegislation should be used. When the work may produce illness not readily recognized by standard medical examinations, specific surveillance should be introduced. If work is carried out with pathogenic microorganisms which cause disease in man and a vaccine is available, all employees should be offered immunization when immunity is not already present. The immunity should be regularly tested in a suitable manner. Pregnant women and mothers breast-feeding their children shou
