BS EN ISO 13408-5-2011 Aseptic processing of health care products Sterilization in place《保健品的无菌加工 适当消毒》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 13408-5:2011Aseptic processing of health care productsPart 5: Sterilization in place (ISO 13408-5:2006)BS EN ISO 13408-5:2011 BRITISH STANDARDNational forewordThis Brit

2、ish Standard is the UK implementation of EN ISO 13408-5:2011. It is identical to ISO 13408-5:2006. Together with the other parts of the BS EN ISO 13408 series, it supersedes BS EN 13824:2004.The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization of medical

3、 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. BSI 2011 ISBN 978 0 580 72611 8 ICS 11.080.01 Complia

4、nce 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 October 2011.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM E

5、N ISO 13408-5 June 2011 ICS 11.080.01 Supersedes EN 13824:2004English Version Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006) Traitement aseptique des produits de sant - Partie 5: Strilisation sur place (ISO 13408-5:2006) Aseptische Herstellung von Prod

6、ukten fr die Gesundheitsfrsorge - Teil 5: Sterilisation vor Ort (ISO 13408-5:2006) This European Standard was approved by CEN on 10 June 2011. 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 na

7、tional 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 v

8、ersion 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

9、, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMI

10、T EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 13408-5:2011: EBS EN ISO 13408-5:2011 EN ISO 13408-5:2011 (E) 3

11、 Foreword The text of ISO 13408-5:2006 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 13408-5:2011 by Technical Committee CEN/TC 204 “Sterilization of medical de

12、vices” the secretariat of which is held by BSI. 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 December 2011, and conflicting national standards shall be withdrawn at the latest by December 2011.

13、 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 or all such patent rights. This document supersedes EN 13824:2004. This document has been prepared under a manda

14、te given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directives. For relationship with EU Directives, see informative Annexes ZA, ZB, or ZC, which are integral parts of this document. According to the CEN/CENELEC Internal Regul

15、ations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Mal

16、ta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 13408-5:2006 has been approved by CEN as a EN ISO 13408-5:2011 without any modification. BS EN ISO 13408-5:2011EN ISO 13408-5:2011 (E) 4 Annex

17、 ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to pr

18、ovide a means of conforming to Essential Requirements of the New Approach Directive 90/385/EEC on active implantable medical devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member

19、State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this Europe

20、an Standard and Directive 90/385/EEC Clauses of this EN Essential Requirements (ERs) of Directive 90/385/EEC Qualifying remarks/Notes 4,5,6,7,8,9,10 7 This relevant Essential Requirement is only partly addressed in this European Standard and only in conjunction with EN ISO 13408-1 WARNING Other requ

21、irements and other EU Directives may be applicable to the product(s) falling within the scope of this Standard. BS EN ISO 13408-5:2011 EN ISO 13408-5:2011 (E) 5 Annex ZB (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devi

22、ces This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Offic

23、ial Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZB.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresp

24、onding Essential Requirements of that Directive and associated EFTA regulations. Table ZB.1 Correspondence between this European Standard and Directive 93/42/EEC Clauses of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4,5,6,7,8,9,10 8.3 This relevant Essential

25、 Requirement is only partly addressed in this European Standard and only in conjunction with EN ISO 13408-1 4,5,6,7,8,9,10 8.4 This relevant Essential Requirement is addressed in this European standard only in conjunction with EN ISO 13408-1 WARNING Other requirements and other EU Directives may be

26、applicable to the product(s) falling within the scope of this Standard. BS EN ISO 13408-5:2011EN ISO 13408-5:2011 (E) 6 Annex ZC (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices This European Stan

27、dard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 98/79/EC on in vitro diagnostic medical devices. Once this standard is cited in the Official

28、 Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZC.1 confers, within the limits of the scope of this standard, a presumption of conformity with the correspond

29、ing Essential Requirements of that Directive and associated EFTA regulations. Table ZC.1 Correspondence between this European Standard and Directive 98/79/EC Clauses of this EN Essential Requirements (ERs) of Directive 98/79/EC Qualifying remarks/Notes 4,5,6,7,8,9,10 B.2.3 This relevant Essential Re

30、quirement is only partly addressed in this European Standard and only in conjunction with EN ISO 13408-1 4,5,6,7,8,9,10 B.2.4 This relevant Essential Requirement is addressed in this European standard only in conjunction with EN ISO 13408-1 WARNING Other requirements and other EU Directives may be a

31、pplicable to the product(s) falling within the scope of this Standard. BS EN ISO 13408-5:2011ISO 13408-5:2006(E) ISO 2006 All rights reserved iiiContents Page1 Scope 12 Normative references 13 Terms and definitions 24 Quality system elements . 34.1 General . 34.2 Management responsibility 34.3 Desig

32、n control . 34.4 Measuring instruments and measuring systems . 35 Process and equipment characterization 45.1 General concepts 45.2 Effectiveness of sterilization in place (SIP) 45.3 Equipment 46 Sterilizing agent characterization 66.1 Selection of sterilizing agent(s) . 66.2 Quality of sterilizing

33、agent(s) . 66.3 Safety and the environment . 67 SIP process 67.1 Process parameters 67.2 Cycle development 78 Validation 78.1 Validation protocol 78.2 Design qualification 78.3 Installation qualification . 78.4 Operational qualification 88.5 Performance qualification 88.6 Review and approval of vali

34、dation . 108.7 Requalification . 109 Routine monitoring and control . 109.1 SIP process control . 109.2 Procedures . 109.3 SIP process records 119.4 Change control 119.5 Maintenance of equipment . 1110 Personnel training . 11Annex A (informative) Steam sterilization in place . 12Bibliography . 14BS

35、EN ISO 13408-5:2011ISO 13408-5:2006(E)iv ISO 2006 All rights reservedForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies(ISO member bodies). The work of preparing International Standards is normally carried out through ISOtechnical

36、committees. Each member body interested in a subject for which a technical committee has beenestablished has the right to be represented on that committee. International organizations, governmental andnon-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with th

37、e InternationalElectrotechnical Commission (IEC) on all matters of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare International Standards. Draft Internationa

38、l Standardsadopted by the technical committees are circulated to the member bodies for voting. Publication as anInternational Standard requires approval by at least 75 % of the member bodies casting a vote.Attention is drawn to the possibility that some of the elements of this document may be the su

39、bject of patentrights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 13408-5 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.ISO 13408 consists of the following parts, under the general title Aseptic processing of health car

40、e products: Part 1: General requirements Part 2: Filtration Part 3: Lyophilization Part 4: Clean-in-place technologies Part 5: Sterilization in place Part 6: Isolator systemsBS EN ISO 13408-5:2011ISO 13408-5:2006(E) ISO 2006 All rights reserved vIntroductionDuring the process of preparing ISO 13408-

41、1, several items, e.g. filtration, freeze drying and sterilization inplace, were found to be in need of supplementary information which was too voluminous to be given incorresponding annexes.This part of ISO 13408 includes requirements and guidance that are to be observed during sterilization in pla

42、ce.The purpose of this part of ISO 13408 is to achieve standardization in the field of validation and routine controlof sterilization in place processes used in the manufacture of health care products.Sterilization in place is, in most instances, preceded by cleaning in place which is described in I

43、SO 13408-4.While methods of cleaning in place and sterilization in place differ considerably in technology, the concept of insitu treatment is similar.The most important issue to consider in establishing sterilization-in-place technology is the design of thesystem(s) to ensure that they be able to s

44、uccessfully sterilize manufacturing equipment to the desired level ofsterility assurance.BS EN ISO 13408-5:2011BS EN ISO 13408-5:2011INTERNATIONAL STANDARD ISO 13408-5:2006(E) ISO 2006 All rights reserved 1Aseptic processing of health care products Part 5:Sterilization in place1Scope1.1 This part of

45、 ISO 13408 specifies the general requirements for sterilization in place (SIP) applied to productcontact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processingand offers guidance on qualification, validation, operation and control.NOTE SIP can be achi

46、eved by using steam or other gaseous or liquid sterilizing agents. Specific guidance on steamsterilization in place, which is the most common method used, is given in Annex A.1.2 This part of ISO 13408 applies to processes where sterilizing agents are delivered to the internal surfacesof equipment t

47、hat can come in contact with the product.1.3 This part of ISO 13408 does not apply to processes where equipment is dismantled and delivered to asterilizer.1.4 This part of ISO 13408 does not supersede or replace national regulatory requirements, such as GoodManufacturing Practices (GMPs) and/or comp

48、endial requirements that pertain in particular national or regionaljurisdictions.1.5 This part of ISO 13408 does not specify requirements for development, validation and routine control of aprocess for inactivating the causative agents of spongiform encephalopathies, such as scrapie, bovinespongifor

49、m encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced inparticular countries for the processing of materials potentially contaminated with these agents. NOTE See also ISO 22442-1, ISO 22442-2 and ISO 22442-3.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For datedreferences, only the edition cited applies. For undated references, the latest edition of the referenced document(including any amendments) applies.ISO 11138 (all p