BS-EN-12683-1998.pdf
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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12683:1998 The Euro
2、pean Standard EN 12683:1998 has the status of a British Standard ICS 07.080; NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Biotechnology Modified organisms for application in the environment Guidance for the characterization of the genetically modified organism by analysis o
3、f the molecular stability of the genomic modification Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 14:45:14 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 12683:1998 This British Standard, having been prepared under the direction of the Sector Committee for Materials and Chemicals, was p
4、ublished under the authority of the Standards Committee and comes into effect on 15 December 1998 BSI 1998 ISBN 0 580 30177 X Amendments issued since publication Amd. No.DateText affected National foreword This British Standard is the English language version of EN 12683:1998. The UK participation i
5、n 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 European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor
6、 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. Cross-references The British Standards which implement international or European publications referred to in this documen
7、t 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 Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British
8、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 comprises a front cover, an inside front cover, the EN title page, pages 2 to 8, an inside back cover and a back cover
9、. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 14:45:14 GMT+00:00 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 1998 CEN All rights of
10、 exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 12683:1998 E EUROPEAN STANDARDEN 12683 NORME EUROPE ENNE EUROPA ISCHE NORM July 1998 ICS 07.080 Descriptors: biotechnology, genetics, modified organisms, environments, environmental protection, analys
11、is method, bioassay, experimental design English version Biotechnology Modified organisms for application in the environment Guidance for the characterization of the genetically modified organism by analysis of the molecular stability of the genomic modification Biotechnologie Organismes modifie s d
12、isse mine s dans lenvironnement Guide pour la caracte risation de lorganisme ge ne tiquement modifie par lanalyse de la stabilite mole culaire de la modification ge nomique Biotechnik Vera nderte Organismen zum Einsatz in der Umwelt Leitfaden fu r die Charakterisierung des gentechnisch vera nderten
13、Organismus durch Untersuchung der molekularen Stabilita t der Genomvera nderung 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 for giving this European Standard the status of a nation
14、al 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 official versions (English, French, German). A version in any
15、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, Belgium, Czech Republic, Denmark, Finland, France, Germany
16、, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 14:45:14 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 2 EN 12683:1998 BSI 1998 Foreword This European Standard has be
17、en 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 identical text or by endorsement, at the latest by January 1999, and conflicting national stan
18、dards shall be withdrawn at the latest by January 1999. 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 c
19、ountries are bound to implement this European Standard: 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 Foreword2 Introduction3 1Scope3 2N
20、ormative references3 3Definitions3 4Molecular stability testing4 5Materials5 6Considerations for experimental procedures5 7Validity of data analysis7 8Documentation of results7 Annex A (informative) Bibliography8 Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 14:45:14 GMT+00:00 2006, Uncontr
21、olled Copy, (c) BSI Page 3 EN 12683:1998 BSI 1998 Introduction This European Standard relates to part of the characterization of genetically modified organisms (GMOs). It is designed as a guideline for adaptation of experimental procedures to the requirements of the specific experimental design. The
22、 characterization of a GMO can include the analysis of: the genomic modification (see EN 12687); the functional expression of the genomic modification (see EN 12682); the molecular stability of the genomic modification. This European Standard deals with the analysis of the molecular stability of the
23、 genomic modification of GMOs. In principle, this European Standard refers to the analysis of the molecular stability of GMOs during their prerelease evaluation and in monitoring of experimental releases. If specific questions concerning molecular stability occur during or after the release, especia
24、lly if the release is scheduled for more than one generation, it is this standard that could apply (see Annex A 3, 4). The analysis of the molecular stability can be based on: the physical analysis of the genetic modification of interest as it exists in the GMO (genomic modification) (see EN 12687);
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