EN IS0 11138-1 EUROPEANSTANDARD NORMEEUROPEENNE EUROPAISCHENORM March 2017 ICS 11.080.20 Supersedes EN IS011138-1:2006 English Version Sterilization of health care products - Biological indicators - Part 1: General requirements (IS0 11138-1:2017) Sterilisation des produits de sante-Indicateurs Sterilisation von Produkten fur die biologiques -Partie 1: Exigences generales (IS0 11138- Gesundheitsfursorge - Biologische Indikatoren - Teil 1: 1:2017) Allgemeine Anforderungen (IS0 11138-1:2017) ThisEuropeanStandardwasapprovedbyCENon19January2017. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status ofa national standard without any alteration.Up-to-date lists and bibliographical references concerningsuch nationalstandards maybeobtained on application to the CEN-CENELEC Management Centreortoany CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by Centre has the same status as the official versions. CENmembers are the national standardsbodies ofAustria,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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. cen EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEEUROPEENDENORMALISATION EUROPAISCHESKOMITEEFURNORMUNG CEN-CENELECManagementCentre:AvenueMarnix17,B-1000Brussels 2017CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11138-1:2017 E worldwideforCENnationalMembers. ENIS011138-1:2017(E) Europeanforeword This document (ENIS0 11138-1:2017) has been prepared by Technical Committee IS0/TC 198 “Sterilization of health care products in collaboration with Technical Committee CEN/TC102 "Sterilizers and associated equipment for processing of medical devices",the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text orby endorsement, at the latest by September 2017 and conflicting national standards shallbewithdrawnatthelatestbySeptember2017. Attention is drawn to the possibility that some of the elements of this document may be the subject of patentrights.CEN[and/or CENELEC]shallnotbeheld responsiblefor identifyinganyorall suchpatent rights. This document supersedes ENIS011138-1:2006 The standard is a full technical revision of the previous version.The following amendments have been made in comparison with EN IS0 11138-1:2006: Normativereferencesandbibliographyupdated; Terms and definitions,FBio-value"und,packaging system"deleted; General manufacturing requirements (clause 4) including Table1 revised, e.g. requirements on traceability added; requirementsoncarrierandtheprimaryand secondarypackagingrevised; general resistance requirements (6.1.2 and 6.4.3) revised; requirementsonsoftwarevalidation (7.4)anddetectionsystems (7.5)added; for determination of growth inhibitionby carriers and primary packaging materials exposed to sterilizationprocessesthenumberof probes was increasedandrequirementsrevised(see Annex B). EN ISO 11138 consists of the following parts, under the general title Sterilization of health care productsBiologicalindicators: Part1:Generalrequirements Part2:Biologicalindicatorsforethyleneoxidesterilizationprocesses Part3:Biological indicatorsformoistheatsterilizationprocesses Part4:Biological indicatorsfordryheatsterilizationprocesses Part5:Biologicalindicatorsforlow-temperaturesteamandformaldehydesterilizationprocesses According to the CEN-CENELEC Internal Regulations, the national standards organizations of the followingcountries are boundtoimplementthisEuropean Standard:Austria,Belgium,Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finl