I.S.ENISO14937:2009 EUROPEANSTANDARD ENISO14937 NORMEEUROPEENNE EUROPAISCHENORM October2009 ICS11.080.01 Supersedes ENISO14937:2000 English Version Sterilizationofhealthcareproducts-General requirementsfor characterizationofasterilizingagentandthedevelopment validationandroutinecontrolofasterilizationprocessfor medicaldevices(iS014937:2009) Sterilisation desproduits de sante-Exigences generales Stenilisation von Produkten fur die Gesundheitsfursorge- pour la caracterisation d'un agent sterilisantet pour la mise Allgemeine Anforderungenandie Charakterisierung eines aupoint, la validation et la verification de routine d'un sterilisierenden Agens und an die Entwicklung,Validierung processus de sterilisation pourdispositifs medicaux (Iso und Lenkung der Anwendung cines Sterilisationsveriahrens 14937:2009) furMedizinprodukte (ISO14937:2009) This European Standard was approvedby CEN on 24September 2009. CENmembers 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 naltional 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 under the responsibility of a CEN member into its own language andnotified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria,Beigium, Bulgaria,Cyprus, Czech Republfic,Denmark.Estonia, Finland, France, Germany.Greece,Hungary,Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg,Malta, Netherlands,Norway.Poland,Portugal, Romania,Slovakia, Slovenia,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMITE EUROPEEN DBNORMALISATION EUROPAISCHESKOMITEEFORNORMUNG Management Centre:Avenue Marnix 17,B-1000Brussels 2009CEN All rights of exploitation in any form and by any means reserved Ref. No.EN ISO 14937:2009: E worldwide for CEN national Members. I.S.EN1SO14937:2009 ENISO14937:2009(E) Contents Page AnnexZA (informative)Relationshipbetweenthis EuropeanStandardandtheEssential RequirementsofEUDirective90/385/EEConActiveimplantableMedicalDevices AnnexZB (informative)Relationshipbetween this European Standard and the Essential RequirementsofEUDirective93/42/EEC onMedicalDevices .... AnnexZc(informative)Relationshipbetween this European Standardand theEssential Requirements ofEUDirective98/79/EC on invitrodiagnosticmedicaldevices..... 2 1.S.ENISO14937:2009 ENISO14937:2009(E) Foreword Thisdocument(ENISO14937:2009)hasbeenpreparedbyTechnicalCommitteeISO/Tc198"Sterilizationof thesecretariatofwhichisheldbyBSl. 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 April 2010, and conflicting national standards shall be withdrawn at the latestbyApril2010. 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 orall such patent rights ThisdocumentsupersedesENIs014937:2000 This document has been prepared under a mandate given to CEN by the European Commission and the European FreeTradeAssociation,and supports essential requirementsofEUDirectives. For relationship with EU Directives, see informative Annex ZA, B and C, which are integral parts of this document. 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,Latvia Lithuania,Luxembourg,Malta, Netherlands,Norway,Poland, Portugal,Romani