BS EN ISO BRITISHSTANDARD 15194:2009 Incorporating corrigendum January2016 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009) ICS 11.100.10 BSi NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BritishStandards BSENISO15194:2009 National foreword This British Standard is the UK implementation of ENISO 15194:2009. It supersedes BSEN12287:1999 which is withdrawn.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. Amendments/corrigenda issued since publication This British Standard Date Comments was published under the authority of the Standards 31 January 2016 Implementation of CENCorrectionNotice12August Policy and Strategy Committee on 31 May 2009 2009: Supersession details updated The British Standards Institution 2016.Published by BSI Standards Limited 2016 ISBN9780580929007 ENISO15194 EUROPEANSTANDARD NORMEEUROPEENNE EUROPAISCHENORM May 2009 ICS 11.100.10 Supersedes EN12287:1999 English Version Invitrodiagnosticmedicaldevices-Measurementofquantities in samples of biological origin-Requirements for certified reference materials and the content of supporting documentation (ls0 15194:2009) Dispositifs medicaux de diagnostic in vitro - Mesurage des In-Vitro-Diagnostika - Messung von GroBen in Proben grandeurs dans les echantillons d'origine biologique biologischen Ursprungs - Anforderungen an zertifizierte Exigences relatives aux materiaux de reference certifies et Referenzmaterialien und an den Inhalt der au contenu de la documentation associee (isO Begleitdokumentation (ISO 15194:2009) 15194:2009) This European Standard was approved by CEN on 16 April 2009 CEN members are bound to comply with the CEN/CENELEC Intermal 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. Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. cen EUROPEAN COMMITTEE FOR STANDARDIZATION COMITEEUROPEEN DENORMALISATION EUROPAISCHES KOMITEE FUR NORMUNG Management Centre:AvenueMarnix 17,B-1000 Brussels 2009CEN All rights of exploitation in any form and by any means reserved Ref.No.EN ISO 15194:2009: E worldwide for CEN national Members. BS ENISO 15194:2009 EN ISO 15194:2009 (E) Foreword 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". text or by endorsement, at the latest by November 20o9, and conflicting national standards shall be withdrawn at thelatest by November2009. This document supersedes EN 12287:1999 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent This document has been prepared under a mandate given to CEN by the European Commission and the For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic,Denmark,Estonia,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,