1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12307 : 1998 The Eu
2、ropean Standard EN 12307 : 1997 has the status of a British Standard ICS 07.080; 07.100.99 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Biotechnology Large-scale process and production Guidance for good practice, procedures, training and control for personnelThis British St
3、andard, having been prepared under the direction of the Sector Board for Materials and Chemicals, was published under the authority of the Standards Board and comes into effect on 15 March 1998 BSI 1998 ISBN 0 580 29261 4 BS EN 12307 : 1998 Amendments issued since publication Amd. No. Date Text affe
4、cted National foreword This British Standard is the English language version of EN 12307 : 1997. 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 Europ
5、ean 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 request to its secretary. Cr
6、oss-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 the BSI Standards Electronic
7、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. Summary of pages This document
8、 comprises a front cover, an inside front cover, the EN title page, pages 2 to 6, an inside back cover and a back cover.CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1997 CEN Al
9、l rights of exploitation in any form and by any means reserved worldwide for CEN national Members Ref. No. EN 12307 : 1997 E EUROPEAN STANDARD EN 12307 NORME EUROPE ENNE EUROPA ISCHE NORM October 1997 ICS 07.080; 07.100.99 Descriptors: Biotechnology, good laboratory practices, work safety, accident
10、prevention, environmental protection, hazards, contamination, micro-organisms, noxious micro-organisms, classifications, personnel, training, specifications English version Biotechnology Large-scale process and production Guidance for good practice, procedures, training and control for personnel Bio
11、technologie Proce de a grande e chelle et production Guide de bonnes practiques, proce dures, formation et contro le pour le personnel Biotechnik Verfahren im Gromastab und Produktion Leitfaden fu r gute Praxis, Arbeitsabla ufe, Ausbildung und U berwachung des Personals This European Standard was ap
12、proved by CEN on 21 August 1997. 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 nation
13、al 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 by translation under the responsibility of a CEN member into its own language and noti
14、fied 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, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland a
15、nd United Kingdom.Page 2 EN 12307 : 1997 BSI 1998 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 identi
16、cal text or by endorsement, at the latest by April 1998, and conflicting national standards shall be withdrawn at the latest by April 1998. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential
17、 requirements of EU Directive(s). 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 directives which may have been made under article 118A of the treaty. In addition, national
18、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 implementing directives based on article 118A and this European Standard may be given in the n
19、ational foreword of the national standard implementing the European Standard. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France,
20、Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword 2 Introduction 3 1 Scope 3 2 Normative references 3 3 Definitions 3 4 General considerations 3 5 Recommendations for handling micro-organisms
21、 in large scale process and production activities 4 6 Instructions and training 5 Annex A (informative) Bibliography 6Page 3 EN 12307 : 1997 BSI 1998 Introduction This European Standard supports industrial activities in the area of biotechnology covering operations with both non-genetically modified
22、 micro-organisms and genetically modified micro-organisms (GMMs), with both non-pathogenic and pathogenic micro-organisms (see annex A 1 2). 1 Scope This European Standard gives guidance for good practice, procedures, training and control for the operation of large scale biotechnological processes.
23、NOTE. For laboratories associated with a large scale process, attention is drawn to prEN 12741 (see annex A 8). In addition, this European Standard gives recommendations for education and training of personnel involved in the large scale handling of micro-organisms in plant building of containment l
24、evels 1, 2, 3 and 4 (see EN 1620). This European Standard aims at the protection of the workers from biological hazards as well as the environment including plants and animals. For operations using micro-organisms only pathogenic for the environment (plant or some animal pathogens e.g. foot and mout
25、h disease virus), this European Standard should be adapted according to the risk for environment and taking into account the recommendations of the national competent authorities. This European Standard is complemented by: physical containment which requirements are given in EN 1620 ; and personal p
26、rotective equipment which requirements are given in EN 143, EN 166, EN 374-1 and EN 374-3. 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
27、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 in it by amendment or revision. For undated references the latest edition of the publication referred to applies. EN 143
28、Respiratory protective devices Particle filters Requirements, testing, marking EN 166 Personal eye protection Specifications EN 374-1 Protective gloves against chemicals and micro-organisms Part 1 : Terminology and performance requirements EN 374-3 Protective gloves against chemicals and micro-organ
29、isms Part 3 : Determination of resistance to permeation by chemicals EN 689 Workplace atmospheres Guidance for the assessment of exposure by inhalation to chemical agents for comparison with limit values and measurement strategy EN 1619 Biotechnology Large-scale process and production General requir
30、ements for management and organization for strain conservation procedures EN 1620 Biotechnology Large scale process and production Plant building according to the degree of hazard 3 Definitions For the purposes of this standard, the following definitions apply: 3.1 controlled area Area constructed a
31、nd/or operated in such a manner as to limit contamination of the other areas by micro-organisms/organisms from within the controlled area EN 1620. 3.2 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
32、injury or damage to health of people and/or to the environment. 3.3 micro-organism Any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material EN 1619. NOTE. For the purposes of this standard, the term micro-organism covers the term of biological
33、agent, according to the Directive 90/679/EEC : micro-organisms, 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 degree of
34、severity of the harm. 3.5 workplace The workplace is the defined area or areas in which the work activities are carried out EN 689. 4 General considerations Before handling, micro-organisms should be classified with respect to human health and safety and hazard to the environment, according to natio
35、nal, European (see annex A 1 and 2) or international rules of classification. They should be handled in appropriate plant buildings of containment levels 1, 2, 3 or 4 as indicated by an assessment of risk. Plant building should be designed in accordance with EN 1620.Page 4 EN 12307 : 1997 BSI 1998 F
36、or any activity involving micro-organisms in large scale process and production activities, the principles of Good Occupational Safety and Hygiene (GOSH) (see annex A 5) Good Microbiological Techniques (see annex A 9), and Good Industrial Large Scale Practice (GILSP) (see annex A 6) should apply. Th
37、e basic recommendations for good microbiological practice are given in 5.1. Additional recommendations may be necessary in case of activities with potentially harmful micro-organisms. Where appropriate, these additional recommendations are given in 5.2, 5.3 and 5.4. When micro-organisms are strictly
38、 pathogenic for plants and animals, specific recommendations aiming to limit or prevent their release into the environment via the workers, can be implemented on a case by case basis. It is emphasized that good microbiological practices are fundamental to safety and cannot generally be replaced by s
39、pecialized equipment which can only supplement it partly. NOTE. In this European Standard, the term good microbiological practice is used throughout. The term good manufacturing practices (see annex A 7) relates mainly to the pharmaceutical industries and is not referred to in this document. 5 Recom
40、mendations for handling micro-organisms in large scale process and production activities 5.1 Basic recommendations for good microbiological practice The following should be observed for handling all types of micro-organisms: a) workplace and environmental exposure to micro-organisms should be kept a
41、s low as reasonably practicable; b) animals not involved in the work should not be permitted in or near the workplace; c) the workplace should be kept neat, clean and free of materials that are not pertinent to the work; d) pipetting by mouth should be prohibited; materials should not be placed in t
42、he mouth; e) all technical procedures should be performed in a way that minimizes the uncontained formation of aerosols and droplets; f) control methods should be set up with engineering at source and these should be supplemented with appropriate personal protective equipment where necessary; g) con
43、trol measures should be carried out and equipment should be tested and maintained; h) eating, drinking, smoking, storing of food and applying cosmetics should not be permitted in any area where infectious materials are handled; i) workers should be provided with appropriate and adequate washing and
44、toilet facilities; j) hands should be washed before leaving the workplace; k) workers should be provided with suitable work clothing and if necessary, additional personal protective equipment; l) local rules for the safety and hygiene of personnel should be formulated and implemented; m) adequate wr
45、itten instructions should be available to keep exposure to any micro-organism to the lowest level that is reasonably practicable; n) training of personnel should be provided and recorded (see clause 6). 5.2 Additional recommendations for handling micro-organisms in a containment level 2 The followin
46、g should be observed in addition to 5.1 for handling micro-organisms in plant building of containment level 2 : a) access to the workplace should be limited to nominated personnel; b) whilst work is in progress access to the controlled area should be restricted and clearly indicated. Entry points to
47、 the area (e.g. doors and windows) should be closed; c) in the event of spillage, the contaminated areas should be disinfected by validated procedures; d) all materials (liquid, solid and gas) should be made safe by validated means before leaving the controlled area; e) material, equipment and work
48、clothing awaiting decontamination should be stored and transported in a safe manner in robust leakproof containers; f) workplaces and equipment should be made safe prior to maintenance work. A system of formal authorization such as permit-to-work, should be instituted for maintenance personnel; g) e
49、ffective disinfectants should be available for routine disinfection; h) hands should be immediately disinfected and then washed when contamination is suspected, after handling infectious materials and also before leaving the workplace; i) workers should immediately report any accident or incident to the person in charge or to the person responsible for safety and health at work; j) work clothing should not be stored in the same lockers or cupboard as street clothing; k) work clot
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