BS EN ISO BRITISH STANDARD 15193:2009 In vitro diagnostio medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (IsO 15193:2009) ICS 11.100.10 BSi NO COPYINGWITHOUTBSIPERMISSION EXCEPTAS PERMITTED BY COPYRIGHTLAW British Standards BSENISO15193:2009 National foreword This British Standard is the UK implementation of EN ISO 15193:2009. It supersedes BS EN 12286:1999 which is withdrawn. 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 purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard Amendments/corrigenda issued since publication was published under the authority of the Standards Policy and Strategy Date Comments Committee on 31 May 2009 @BSI2009 ISBN 978 0 580 57551 8 EN ISO 15193 EUROPEANSTANDARD NORME EUROPEENNE EUROPAISCHENORM May 2009 ICS 11.100.10 English Version Invitrodiagnosticmedicaldevices-Measurementofquantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (lso 15193:2009) Dispositifs medicaux de diagnostic in vitro - Mesurage des In-vitro-Diagnostika - Messung von GroBen in Proben grandeurs dans des echantllons d'origine biologique - biologischen Ursprungs - Anforderungen an den Inhalt und Exigences relatives au contenu et a la présentation des die Darstellung von Referenzmessverfahren (ISO procedures de mesure de reference (ISo 15193:2009) 15193:2009) This European Standard was approved by CEN on 16 April 2009. 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 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 translation official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. cen EUROPEAN COMMITTEE FOR STANDARDIZATION COMITE EUROPEEN DE NORMALISATION EUROPAISCHES KOMITEE FUR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels @2009CEN All rights of exploitation in any form and by any means reserved Ref.No.ENISO 15193:2009:E worldwide for CEN national Members. BSENISO15193:2009 EN ISO15193:2009 (E) Foreword This document (ENISO15193:2009)has been prepared by Technical Committee CEN/TC 140"In vitro diagnostic medical devices", the secretariat of which is held by DiN, in collaboration with Technical Committee ISO/TC 212"Clinical laboratory testing and in vitro diagnostic test systems". 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 November 20o9, and conflicting national standards shall be withdrawn at the latest by November2009. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CEN by the European Commission and the For relationship with EC Directive, see informative Annex ZA, which is an integral part of this documen