EN 12307-1997 en Biotechnology - Large-Scale Process and Production - Guidance for Good Practice Procedures Training and Control for Personnel《生物技术 规模加工和生产 良好习惯 程序 人员培训和管理指南》.pdf
《EN 12307-1997 en Biotechnology - Large-Scale Process and Production - Guidance for Good Practice Procedures Training and Control for Personnel《生物技术 规模加工和生产 良好习惯 程序 人员培训和管理指南》.pdf》由会员分享,可在线阅读,更多相关《EN 12307-1997 en Biotechnology - Large-Scale Process and Production - Guidance for Good Practice Procedures Training and Control for Personnel《生物技术 规模加工和生产 良好习惯 程序 人员培训和管理指南》.pdf(9页珍藏版)》请在麦多课文档分享上搜索。
1、12307 : 1998 Biotechnology - Large-scale process and production - Guidance for good practice, procedures, training and control for personnel The European 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 COPYR
2、IGHT LAW BS EN 12307 : 1998 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 CIv58, Biotechnology, which has the responsibility to: - aid enquirem to understand the text; - present
3、 to the responsible European committee any enquiries on the interpretation, or proposais for change, and keep the UK interests informed; - monitor related intedonai and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on reque
4、st to its secretary. Cross-references The British Standards which implement intrnational or European pubiications 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
5、 Standards Electronic Catalogue. A British Standard does not purport to include ail the necessary provisions of a conirad. 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 o
6、f pages This document comprises a hnt cover, an inside front cover, the EN title page, pages 2 to 6, an inside back cover and a back cover. This British Standard, having been prepared under the direction of the Sector Board for Materiais and Chemicals, was published under the authority of the Standa
7、rds Board and comes into effect on 15 March 1998 Amendments issued since publication ID* (Paaffected Amd No. O BSI 1998 ISBN O 680 29261 4 EUROPEAN sTANDAR;D NO- EUROPENNE EXJROP- NORM EN 12307 October 1997 ICs 07.080 07.100.99 Descriptors: Biotechnology, good laboratory practices, work safety, acci
8、dent prevention, environmental protection, hazards, contamination, micro-organisms, noxious micro-organisms, classifications, personnel, training, specifications Engush version Biotechnology - Laqpscale proces and production- for pemnnel Guidance for good practice, procedures, trainin$ and control B
9、iotechnologie - Procd grande chelle et production - Guide de bonnes practiques, procdures, formation et contrle pour le personnel Biotechnik - Verfahren im Grol3maBstab und Produktion - Leitfaden fur gute Praxis, Arbeitsablufe, Ausbildung und berwachung des Personals This European Standard was appro
10、ved by CEN on 21 August 1997. CEN members are bound to comply with the CENKENELEC 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 national s
11、tandards 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 notifed
12、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, Rance, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and Uni
13、ted Kingdom. European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels O 1997 CEN AU rights of exploitation in any form and by any means reserved worldwide for CEN national Members Ref. No. EN 12307 :
14、 1997 E Page 2 EN 12307 : 1997 Foreword This European Standard has been prepared by “bchnical Committee CENR% 233, Biotechnoloa, 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 endors
15、ement, at the latest by Apri 1998, and conflicting national standards shall be withdrawn at the latest by Aprii 1998. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free kade Association, and supports essential requirements of EU Dir
16、ective(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 formai legal relationship with directives which may have been made under article 118A of the treaty In addition, national legislation in the membe
17、r states may contain more stringent requirements than the minimum requirements of a directive based on article 11 and - personal protective equipment which requirements are given in EN 143, EN 166, EN 3741 and EN 374-3. 2 Normative references This European Standard incorporates by dated or undated r
18、eference, provisions from other publications. These normative references axe 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 ony when incorp
19、orated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. EN 143 Respiratmy protective dewices - Particle filters - Requirements, testing, marking Personal eye protectwn - Spei5fixation.s Protective gimes against chemicals and micro-orga
20、nisms - Part 1 : Tminology and perfomza,nce requirements EN 166 EN 3741 Page 3 EN 12307 : 1997 EN 374-3 Frotmtive gloves against chernicals and micro-organisms - Part 3 : Determination of resistance to permeatwn by chemicals Worlcpace atmospheres - Guidance for the assessment of exposure by inhalati
21、on to chemical agents for comparison wih limit values and measurement stmtegy Biotechnology - Large-scale process and pmduction - GmJ requirements for rna,rmgernent and organization for strain consmyation procedures Biotmhrwlogy - Large scale process and productwn - Plant building accoding to the de
22、gree of hazard EN 689 EN 1619 EN 1620 3 Definitions For the purposes 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-organismslorganisms from within the controlled area EN 1
23、6201. 3.2 hazard Inlxinsic potential property or abiiity 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 andor to the environment. 3.3 micro-organism Any microbiological enti, cellular or non-cellular, capabl
24、e of replication or of transferring genetic material EN 16191. 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
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