BS EN 12685-1998 Biotechnology - Modified organisms for application in the environment - Guidance for the monitoring strategies for deliberate release of genetically modified micro.pdf
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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12685:1998 The Euro
2、pean Standard EN 12685:1998 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 Modified organisms for application in the environment Guidance for the monitoring strategies for deliberate release of genetical
3、ly modified micro-organisms, including virusesBS EN 12683:1998 This British Standard, having 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 December 1998 BSI 1998 ISBN 0 5
4、80 30178 8 Amendments issued since publication Amd. No. Date Text affected National foreword This British Standard is the English language version of EN 12685:1998. The UK participation in its preparation was entrusted to Technical Committee CII/58, Biotechnology, which has the responsibility to: ai
5、d 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 UK. A list of organizations represent
6、ed 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 “International Standards Correspondence
7、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 British Standard does not of itsel
8、f 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 10, an inside back cover and a back cover.CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Nor
9、mung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1998 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 12685:1998 E EUROPEAN STANDARD EN 12685 NORME EUROPE ENNE EUROPA ISCHE NORM July 1998 ICS 07.080; 07.100.01 Descript
10、ors: biotechnology, genetics, modified organisms, environments, environmental protection, inspection, experimental design English version Biotechnology Modified organisms for application in the environment Guidance for the monitoring strategies for deliberate releases of genetically modified micro-o
11、rganisms, including viruses Biotechnologie Organismes modifie s disse mine s dans lenvironnement Guide des strate gies de surveillance pour les disse minations volontaires de micro-organismes ge ne tiquement modifie s, y compris de virus Biotechnik Vera nderte Organismen zum Einsatz in der Umwelt Le
12、itfaden fu r die U berwachungsstrategien bei der absichtlichen Freisetzung gentechnisch vera nderter Mikroorganismen einschlielich Viren This European Standard was approved by CEN on 1 July 1998. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions
13、 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 European Standard exists in three offic
14、ial 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 national standards bodies of Austria, B
15、elgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.Page 2 EN 12685:1998 BSI 1998 Foreword This European Standard has been prepared by Technical Committee CEN/TC 233, Biot
16、echnology, 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 1999, and conflicting national standards shall be withdrawn at the latest by January 1
17、999. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Stand
18、ard: Austria, Belgium, Czech Republic, Denmark, Finland, France, 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 Genera
19、l considerations 4 5 Monitoring strategy 4 Annex A (informative) Relationship between a sampling and monitoring valid strategy 9 Annex B (informative) Bibliography 10Page 3 EN 12685:1998 BSI 1998 Introduction When genetically modified micro-organisms including viruses (GMMs) are subject to experimen
20、tal release into the environment, it is important to ensure the validity of a monitoring strategy for testing their behaviour. In this European Standard, monitoring refers both to the monitoring of the occurrence, persistence and/or spread of the GMM and/or the gene(s) involved in the modification a
21、nd its performance in the environment. This European Standard is intended to aid the experimenter in the design of a monitoring strategy appropriate to monitoring objectives. The development of a monitoring valid strategy is directly linked to the development of the sampling strategy as described in
22、 EN 12686. Therefore, this European Standard gives the experimenter a list of points that should be considered in determining the validity of a monitoring strategy comprising valid design, review, execution and documentation of a monitoring protocol. 1 Scope This European Standard provides guidance
23、on factors and criteria considered for the determination of the suitability and validity of the design, development and execution of a monitoring strategy for GMM. Monitoring encompasses detection of genotypic and phenotypic properties, as well as detection of viral material and/or symptoms specific
24、 for the infected host, for the identification of GMMs in an experimental release. This European Standard provides the person conducting a monitoring programme with a list of factors and criteria that should be considered in determining the validity of the proposed strategy for monitoring. This Euro
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