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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 personnel Licensed Copy:
3、 sheffieldun sheffieldun, na, Sat Oct 28 14:44:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI This British Standard, 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 199
4、8 BSI 1998 ISBN 0 580 29261 4 BS EN 12307 : 1998 Amendments issued since publication Amd. No.DateText affected 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, Biotechnolog
5、y, which has the responsibility to: aid enquirers to understand the text; present 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
6、 UK. A list of organizations represented on this committee can be obtained on request 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 In
7、ternational Standards Correspondence Index, or by using the Find facility 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
8、British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 6, an inside back cover and a back cover. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 14:44:43 GMT+00:00
9、 2006, Uncontrolled Copy, (c) BSI 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 All rights of exploitation in any form and by any means reserved worldwide for CEN natio
10、nal Members Ref. No. EN 12307 : 1997 E EUROPEAN STANDARDEN 12307 NORME EUROPE ENNE EUROPA ISCHE NORM October 1997 ICS 07.080; 07.100.99 Descriptors: Biotechnology,goodlaboratorypractices,worksafety,accidentprevention,environmentalprotection,hazards, contamination, micro-organisms, noxious micro-orga
11、nisms, classifications, personnel, training, specifications English version Biotechnology Large-scale process and production Guidance for good practice, procedures, training and control for personnel Biotechnologie Proce de a grande e chelle et production Guide de bonnes practiques, proce dures, for
12、mation 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 approved by CEN on 21 August 1997. CEN members are bound to comply with the CEN/CENELEC Internal Re
13、gulations 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 may be obtained on application to the Central Secretariat or to any CEN member. This
14、 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 Central Secretariat has the same status as the official versions. CEN members are the
15、 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 Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 14:44:43 GMT+00:00 2006
16、, Uncontrolled Copy, (c) BSI 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 o
17、f an identical 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 support
18、s essential 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
19、, 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 implementing directives based on article 118A and this European Standard may be giv
20、en in the national 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, Finlan
21、d, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword2 Introduction3 1Scope3 2Normative references3 3Definitions3 4General considerations3 5Recommendations for handling micro-organisms
22、 in large scale process and production activities4 6Instructions and training5 Annex A(informative) Bibliography6 Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 14:44:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 12307 : 1997 BSI 1998 Introduction This European Standard supports in
23、dustrial activities in the area of biotechnology covering operations with both non-genetically modified 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 p
24、ractice, procedures, training and control for the operation of large scale biotechnological processes. 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
25、of personnel involved in the large scale handling of micro-organisms in plant building of containment levels 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
26、 micro-organisms only pathogenic for the environment (plant or some animal pathogens e.g. foot and mouth 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 Sta
27、ndard is complemented by: physical containment which requirements are given in EN 1620 ; and personal protective 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
28、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 in it by amendment
29、 or revision. For undated references the latest edition of the publication referred to applies. EN 143Respiratory protective devices Particle filters Requirements, testing, marking EN 166Personal eye protection Specifications EN 374-1Protective gloves against chemicals and micro-organisms Part 1 : T
30、erminology and performance requirements EN 374-3Protective gloves against chemicals and micro-organisms Part 3 : Determination of resistance to permeation by chemicals EN 689Workplace atmospheres Guidance for the assessment of exposure by inhalation to chemical agents for comparison with limit value
31、s and measurement strategy EN 1619Biotechnology Large-scale process and production General requirements for management and organization for strain conservation procedures EN 1620Biotechnology Large scale process and production Plant building according to the degree of hazard 3 Definitions For the pu
32、rposes of this standard, the following definitions apply: 3.1 controlled area Area constructed and/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 som
33、ething (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 to the environment. 3.3 micro-organism Any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material EN 1619.
34、 NOTE. For the purposes of this standard, the term micro-organism covers the term of biological 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, all
35、ergy or toxicity. 3.4 risk Probability of occurrence of a hazard causing harm and the degree of 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 clas
36、sified with respect to human health and safety and hazard to the environment, according to national, 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
37、. Plant building should be designed in accordance with EN 1620. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 14:44:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 12307 : 1997 BSI 1998 For any activity involving micro-organisms in large scale process and production activities, the
38、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. The basic recommendations for good microbiological practice are given in 5.1. Additional recommend
39、ations 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 pathogenic for plants and animals, specific recommendations aiming to limit or prevent their re
40、lease 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 specialized equipment which can only supplement it partly. NOTE. In this European Standard, the t
41、erm 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 Recommendations for handling micro-organisms in large scale process and production activities 5.1 Bas
42、ic 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 as low as reasonably practicable; b) animals not involved in the work should not be permitted in
43、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 the mouth; e) all technical procedures should be performed in a way that minimizes the uncontaine
44、d 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) control measures should be carried out and equipment should be tested and maintained; h) eating, dr
45、inking, 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 toilet facilities; j) hands should be washed before leaving the workplace; k) workers should be
46、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 written instructions should be available to keep exposure to any micro-organism to the lowest leve
47、l 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 following should be observed in addition to 5.1 for handling micro-organisms in plant building of contai
48、nment 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 the area (e.g. doors and windows) should be closed; c) in the event of spillage, the contaminat
49、ed 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 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;
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