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.pdf

1、BSI Standards Publication PD CEN/TS 16827-2:2015 Molecular in vitro diagnostic examinations Specifications for pre-examination processes for FFPE tissue Part 2: Isolated proteins PD CEN/TS 16827-2:2015 Incorporating corrigendum September 2015PD CEN/TS 16827-2:2015 PUBLISHED D OC UMEN T National fore

2、word This Published Document is the UK implementation of CEN/TS 16827-2:2015. The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purpor

3、t to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2015. Published by BSI Standards Limited 2015 ISBN 978 0 580 91720 2 ICS 11.100.10 Compliance with a British Standard cannot confer immunity from legal obliga

4、tions. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2015. Amendments/corrigenda issued since publication Date Text affected 30 September 2015 Implementation of CEN Correction Notice 28 August 2015: Annex A updatedPD CEN/TS 16827-

5、2:2015TECHNICAL SPECIFICATION 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

6、in vitro - Spcifications pour 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 appr

7、oved by CEN on 6 July 2015 for 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.

8、 CEN members are required to announce 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 a

9、bout the possible conversion of 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,

10、 Latvia, Lithuania, Luxembourg, 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 2015 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 E