BS EN ISO 11140-1:2014 Incorporating corrigendum January 2015 BSl Standards Publication Sterilization of health care products-Chemicalindicators Part I: General requirements bsi. ..making excellence a habit. BRITISH STANDARD BS EN ISO 11140-1:2014 National foreword This British Standard is the UK implementation of EN ISO 11140-1:2014. It supersedes BS EN ISO 11140-1:2009 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization of medical devices. 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 2015 Published by BSI Standards Limited 2015 ISBN 978 0 580 89220 2 ICS 11.080.01 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 November 2014. Amendments/corrigenda issued since publication Date Text affected 31 January 2015 Implementation of CEN Correction Notice 10 December 2014. Table ZA.1 first column updated ENIS0 11140-1 EUROPEANSTANDARD NORME EUROPEENNE EUROPAISCHENORM November 2014 ICS 11.080.01 Supersedes EN ISO 11140-1:2009 English Version Sterilization of health care products s - Chemical indicators -Part 1: General requirements (lSO 11140-1:2014) Sterilisation des produits de sante - Indicateurs chimiques - Sterilisation von Produkten fur die Gesundheitsfursorge - Partie 1: Exigences generales (iSO 11140-1:2014) Chemische Indikatoren - Teil 1: Allgemeine Anforderungen (ISO 11140-1:2014) This European Standard was approved by CEN on 23 August 2014. CEN members are boundto comply with the CEN/CENELEC Internal Regulations which stipulate the conditions forgiving 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 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 Kingdom. EUROPEAN COMMITTEEFOR STANDARDIZATION C OMI TE EUR OPEEN DE NOR M ALI S ATI ON EUR OPA IS CHESKOMITEEFUR NORM UNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels @2014CEN All rights of exploitation in any form and by any means reserved Ref. No.EN ISO 11140-1:2014 E worldwide for CEN national Members