BS EN 13060-2014 + A1-2018

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BSI Standards Publication WB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06 Small steam sterilizers BS EN 13060:2014+A1:2018 Incorporating corrigendum December 2018 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13060:2014+A1 November 2018 ICS 11.080.10 Supersedes EN 13060:2014 English Version Small steam sterilizers Petits strilisateurs la vapeur deau Dampf-Klein-Sterilisatoren This European Standard was approved by CEN on 15 November 2014 and includes Amendment 1 approved by CEN on 24 June 2018. 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13060:2014+A1:2018 E National foreword This British Standard is the UK implementation of EN 13060:2014+A1:2018. It supersedes BS EN 13060:2014, which is withdrawn. The start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indicating changes to CEN text carry the number of the CEN amendment. For example, text altered by CEN amendment A1 is indicated by . The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization and Associated Equipment and Processes. 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 2018 Published by BSI Standards Limited 2018 ISBN 978 0 539 03273 4 ICS 11.080.10 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 31 December 2014. Amendments/corrigenda issued since publication Date Text affected 30 November 2018 Implementation of CEN amendment A1:2018 31 December 2018 Implementation of CEN correction notice 28 No- vember 2018: supersession details added to title page and European foreword BRITISH STANDARDBS EN 13060:2014+A1:2018 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13060:2014+A1 November 2018 ICS 11.080.10 Supersedes EN 13060:2014 English Version Small steam sterilizers Petits strilisateurs la vapeur deau Dampf-Klein-Sterilisatoren This European Standard was approved by CEN on 15 November 2014 and includes Amendment 1 approved by CEN on 24 June 2018. 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13060:2014+A1:2018 E BS EN 13060:2014+A1:2018 EN 13060:2014+A1:2018 (E) 2 Contents Page European foreword . 4 Introduction . 6 1 Scope . 7 2 Normative references . 7 3 Terms and definitions . 8 4 General technical requirements . 16 4.1 Dimensions . 16 4.2 Materials . 16 4.3 Design and construction . 17 4.4 Instrumentation, indication and registration devices. 18 4.5 Control systems . 27 4.6 Process . 29 4.7 Services and local environment . 30 4.8 Information to be provided . 31 4.9 Marking . 35 4.10 Accessories . 36 5 Performance requirements . 36 5.1 General . 36 5.2 Air leakage rate . 37 5.3 Attainment of the sterilization conditions . 37 5.4 Product compatibility . 37 5.5 Drying . 38 5.6 Microbicidal efficacy . 38 5.7 Non-condensable gases . 38 6 Safety, risk control and usability . 38 6.1 General requirements . 38 6.2 Requirements for EMC. 39 6.3 Requirements for pressure equipment . 39 6.4 Requirements for risk control . 40 7 Categories of tests . 40 7.1 General . 40 7.2 Type tests . 41 7.3 Works test . 41 7.4 Installation tests . 42 8 Test equipment . 42 8.1 General . 42 8.2 Temperature sensors . 42 8.3 Thermometric recording instrument . 43 8.4 Pressure measurement and recording instrument . 43 8.5 Test equipment for the performance of the air leakage test . 44 8.6 Porous load . 45 8.7 Solid load, unwrapped . 47 BS EN 13060:2014+A1:2018 EN 13060:2014+A1:2018 (E) 3 8.8 Solid load, single wrapped. 47 8.9 Solid load, double wrapped. 47 8.10 Process challenge device (PCD) and chemical indicator for narrow lumen . 48 8.11 Process challenge device and chemical indicator for simple hollow item . 48 8.12 Balance for load dryness test . 49 9 Test programme . 49 10 Test methods . 51 10.1 General requirements on technical tests . 51 10.2 Air leakage test . 51 10.3 Dynamic sterilizer chamber pressure test . 53 10.4 Empty chamber test . 54 10.5 Solid load test . 54 10.6 Narrow lumen test . 54 10.7 Simple hollow item test . 55 10.8 Small porous load test . 56 10.9 Full porous load test (single and double wrapped) . 57 10.10 Small porous items test (single and double wrapped) . 58 10.11 Solid load dryness test . 58 10.12 Porous load dryness test (small and full, single and double wrapped) . 59 10.13 Small porous items dryness test (single and double wrapped). 60 10.14 Non-condensable gases test . 60 10.15 Microbiological test for solid loads .
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