BSENIS020166-1:2018 BSl Standards Publication Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue Part 1: Isolated RNA (IS0 20166-1:2018) bsi. BSEN ISO 20166-1:2018 EN IS0 20166-1 EUROPEAN STANDARD NORME EUROPEENNE EUROPAISCHE NORM December2018 ICS 11.100.10 SupersedesCEN/TS16827-1:2015 English Version Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA (IS0 20166-1:2018) Analyses de diagnostic moleculaire in vitro Molekularanalytische in-vitro-diagnostische Verfahren Spécificationsrelatives auxprocessuspréanalytiques Spezifikationen fur praanalytischeProzessefur pour les tissus fixes au formol et inclus en paraffine formalinfixierte und paraffineingebettete (FFPE)- (FFPE) -Partie 1: ARN extrait (IS0 20166-1:2018) Gewebeproben - Teil 1: Isolierte RNS (ISO 20166- 1:2018) This European Standard was approved by CEN on 22 November 2018 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 national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by Centre has the same status as the official versions. 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, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. cen EUROPEAN COMMITTEEFOR STANDARDIZATION COMITE EUROPEEN DE NORMALISATION EUROPAISCHESKOMITEEFURNORMUNG CEN-CENELEC Management Centre: Rue dela Science 23, B-1040 Brussels @2018CEN All rights of exploitation in any form and by any means reserved Ref.No.EN ISO 20166-1:2018 E worldwide for CEN national Members. BSENISO20166-1:2018 EN IS0 20166-1:2018 (E) European foreword This document (EN IS020166-1:2018) has been prepared by Technical Committee IS0/TC 212"Clinical laboratory testing and in vitro diagnostic test systems" in collaboration with Technical Committee CEN/TC 140"In vitro diagnostic medical devices"the secretariat of which is held by DIN. 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 June 2019,and conflicting national standards shall be withdrawn at the latest by June 2019. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document supersedes CEN/TS 16827-1:2015. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: 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, Malta, Netherlands,Norway,Poland,Portugal, Romania, Serbia, Slovakia, Slovenia,Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of IS020166-1:2018 has been approved by CEN as ENIS020166-1:2018 without any modification 3