BS EN ISO 15197:2013 BSl Standards Publication In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013) bsi. ..making excellence a habit. BS EN ISO 15197:2013 BRITISH STANDARD National foreword This British Standard is the UK implementation of EN ISO 15197:2013. It supersedes BS EN ISO 15197:2003 which is withdrawn.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. @ The British Standards Institution 2013. Published by BSI Standards Limited 2013 ISBN978 0 58068839 3 ICS11.040.55 Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2013. Amendments issued since publication Date Text affected EUROPEANSTANDARD EN ISO 15197 NORME EUROPEENNE EUROPAISCHE NORM May 2013 ICS11.100.10 Supersedes EN ISO 15197:2003 EnglishVersion In vitro diagnostic test systems - Requirements for blood- glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013) Systemes d'essais de diagnostic in vitro - Exigences Testsysteme fur die In-vitro-Diagnostik - Anforderungen an relatives auxsystemes d'autosurveillancedelaglycemie Blutzuckermesssysteme zur Eigenanwendung beim destines a la prise en charge du diabete sucre (isO Diabetes mellitus (ISO 15197:2013) 15197:2013) This European Standard was approved by CEN on 15 May 2013. 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 translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. cen EUROPEAN COMMITTEEFOR STANDARDIZATION COMITEEUROPEENDENORMALISATION EUROPAISCHESKOMITEEFURNORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels @2013CEN Ref. No. EN ISO 15197:2013: E worldwide for CEN national Members.