BS PD CEN TS 16827-2-2015 Molecular in vitro diagnostic examinations Specifications for pre-examination processes for FFPE tissue Isolated proteins《分子体外诊断检查 石蜡包埋组织的预检测过程的规格 分离蛋白》.pdf
《BS PD CEN TS 16827-2-2015 Molecular in vitro diagnostic examinations Specifications for pre-examination processes for FFPE tissue Isolated proteins《分子体外诊断检查 石蜡包埋组织的预检测过程的规格 分离蛋白》.pdf》由会员分享,可在线阅读,更多相关《BS PD CEN TS 16827-2-2015 Molecular in vitro diagnostic examinations Specifications for pre-examination processes for FFPE tissue Isolated proteins《分子体外诊断检查 石蜡包埋组织的预检测过程的规格 分离蛋白》.pdf(24页珍藏版)》请在麦多课文档分享上搜索。
1、BSI Standards PublicationPD CEN/TS 16827-2:2015Molecular in vitro diagnosticexaminations Specificationsfor pre-examination processesfor FFPE tissuePart 2: Isolated proteinsPD CEN/TS 16827-2:2015Incorporating corrigendum September 2015PD CEN/TS 16827-2:2015 PUBLISHED DOCUMENTNational forewordThis Pub
2、lished Document is the UK implementation ofCEN/TS 16827-2:2015.The UK participation in its preparation was entrusted to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can be obtainedon request to its secretary.This publication does not purport to include all th
3、e necessary provisionsof a contract. Users are responsible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 91720 2ICS 11.100.10Compliance with a British Standard cannot confer immunity from legal obligations.This British Stand
4、ard was published under the authority of the StandardsPolicy and Strategy Committee on 31 August 2015.Amendments/corrigenda issued since publicationDate Text affected30 September 2015 Implementation of CEN Correction Notice 28 August 2015: Annex A updatedPD CEN/TS 16827-2:2015TECHNICAL SPECIFICATION
5、 SPCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN/TS 16827-2 August 2015 ICS 11.100.10 English Version Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 2: Isolated proteins Tests de diagnostic molculaire in vitro - Spcifications pour
6、les processus pranalytiques pour tissu FFPE - Partie 2: Protines extraites Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen fr pranalytische Prozesse fr FFPE-Gewebeproben - Teil 2: Isolierte Proteine This Technical Specification (CEN/TS) was approved by CEN on 6 July 2015 for
7、provisional application. The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard. CEN members are required to an
8、nounce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS) until the final decision about the possible conversion of
9、 the CEN/TS into an EN is reached. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg,
10、 Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 201
11、5 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. CEN/TS 16827-2:2015 EPD CEN/TS 16827-2:2015CEN/TS 16827-2:2015 (E) 2 Cont ent s Page European foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 I nt roduc t i on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 1 Sc ope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
14、. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 2 Norm at i v e referenc es . . . . . . . . . . . . . . . .
15、. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 3 Term s and defi ni t i ons . . . . . . . . . . . . . . . . . . . . . . . . . . .
16、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 4 G eneral c ons i derat i ons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
17、. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 5 O ut s i de t h e l ab orat ory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
18、. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 5. 1 P ri m ary t i s s ue c ol l ec t i on m anual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
19、. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 5. 1. 1 I nform at i on ab out t h e pri m ary s am pl e donor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
20、 . . . . . . . . . . . . . . . . . . . . . . . 8 5. 1. 2 I nform at i on on t h e pri m ary t i s s ue s am pl e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 5. 1.
21、 3 I nform at i on on t h e pri m ary t i s s ue s am pl e proc es s i ng . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 5. 2 Trans port req ui rem ent s . . . . . . . . . . . . . . . . . . . . . . . . . .
22、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 6 I ns i de t h e l ab orat ory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
23、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 6. 1 I nform at i on on t h e pri m ary t i s s ue s am pl e rec ei pt . . . . . . . . . . . . . . . . . . . . . . . . . . .
24、. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 6. 2 F orm al i n fi x at i on of t h e s pec i m en . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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