DIN EN 13060-2015 Small steam sterilizers German version EN 13060 2014《小型蒸汽灭菌器 德文版本EN 13060-2014》.pdf

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1、March 2015 Translation by DIN-Sprachendienst.English price group 26No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS

2、11.080.10!%_“2299160www.din.deDDIN EN 13060Small steam sterilizers;English version EN 13060:2014,English translation of DIN EN 13060:2015-03Dampf-Klein-Sterilisatoren;Englische Fassung EN 13060:2014,Englische bersetzung von DIN EN 13060:2015-03Petits strilisateurs la vapeur deau;Version anglaise EN

3、13060:2014,Traduction anglaise de DIN EN 13060:2015-03SupersedesDIN EN 13060:2010-06See start of applicationwww.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 83 pages 01.15 DIN EN 13060:2015-03 2 A comma is used as the decimal marker. Sta

4、rt of application The start of application of this standard is 2015-03-01. DIN EN 13060:2010-06 may be used in parallel until 2015-12-31. National foreword This document (EN 13060:2014) has been prepared by Technical Committee CEN/TC 102 “Sterilizers for medical purposes” (Secretariat: DIN, Germany)

5、. The responsible German body involved in its preparation was the DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-04-01 AA Dampf-Sterilisatoren. Amendments This standard differs from DIN EN 13060:2010-06 as follows: a) the scope of the standard has been revis

6、ed with the aim to define small and large sterilizers in terms of the chamber volume; b) normative references, terms and definitions have been updated, e.g. “hollow load A” has been changed to “3.18 narrow lumen” and “hollow load B” has been changed to “3.30 simple hollow items”; c) in Clause 4 vari

7、ous subclauses and relevant requirements have been added, such as: General requirements for design and construction (4.3.1), Vibrations (4.3.5), Noise (4.3.6), Steam penetration test (4.5.1.6) and Software (4.5.4); d) Subclause 4.8 has been divided into two subclauses: 4.8 “Information to be provide

8、d” and 4.9 “Marking”; e) requirements in Subclause 5.3 on attainment of the sterilization conditions have been revised; f) requirements in Clause 6 “Safety, risk control and usability” have been revised, e.g. requirements on electromagnetic compatibility (EMC), pressure equipment and risk control ha

9、ve been added; g) requirements on the sound power level (Subclause 7.2.6) have been added; h) requirements in Subclause 8.6 “Porous load” have been revised; i) requirements in Subclause 8.10 for the process challenge device (PCD) and chemical indicators for products with narrow lumen have been revis

10、ed; j) Annex A has been revised, e.g. the defined hollow loads A and B have been replaced by products with narrow lumen or simple hollow items; k) an example of a process challenge device for narrow lumen (PCD) has been moved to Annex G; l) Annex ZA including Table ZA.1 on EU Directive 93/42/EEC on

11、medical devices and Table ZA.2 on the Machinery Directive 2006/42/EG has been updated due to the changes made in the standard; m) the standard has been editorially revised. DIN EN 13060:2015-03 3 Previous editions DIN 58946-5: 1978-10, 1987-01 DIN 58946-8: 1986-03 DIN EN 13060: 2004-09, 2009-10, 201

12、0-06 DIN EN 13060 Corrigendum 1: 2007-05 DIN EN 13060:2015-03 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13060 December 2014 ICS 11.080.10 Supersedes EN 13060:2004+A2:2010English Version Small steam sterilizers Petits strilisateurs la vapeur deau Dampf-Kl

13、ein-Sterilisatoren This European Standard was approved by CEN on 15 November 2014. 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

14、 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 r

15、esponsibility 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

16、 Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE

17、NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13060:2014 EEN 13060:2014 (E) 2 Contents Page Foreword 4 Introductio

18、n .6 1 Scope 7 2 Normative references 7 3 Terms and definitions .8 4 General technical requirements 15 4.1 Dimensions 15 4.2 Materials 15 4.3 Design and construction 16 4.4 Instrumentation, indication and registration devices . 17 4.5 Control systems 25 4.6 Process 26 4.7 Services and local environm

19、ent 27 4.8 Information to be provided 28 4.9 Marking 32 4.10 Accessories . 33 5 Performance requirements 33 5.1 General . 33 5.2 Air leakage rate . 34 5.3 Attainment of the sterilization conditions 34 5.4 Product compatibility . 34 5.5 Drying . 35 5.6 Microbicidal efficacy 35 5.7 Non-condensable gas

20、es 35 6 Safety, risk control and usability 35 6.1 General requirements . 35 6.2 Requirements for EMC . 36 6.3 Requirements for pressure equipment 36 6.4 Requirements for risk control . 37 7 Categories of tests 37 7.1 General . 37 7.2 Type tests 37 7.3 Works test 38 7.4 Installation tests 38 8 Test e

21、quipment . 39 8.1 General . 39 8.2 Temperature sensors . 39 8.3 Thermometric recording instrument. 39 8.4 Pressure measurement and recording instrument . 40 8.5 Test equipment for the performance of the air leakage test 41 8.6 Porous load . 42 8.7 Solid load, unwrapped . 43 8.8 Solid load, single wr

22、apped 44 8.9 Solid load, double wrapped . 44 8.10 Process challenge device (PCD) and chemical indicator for narrow lumen 44 DIN EN 13060:2015-03 EN 13060:2014 (E) 3 8.11 Process challenge device and chemical indicator for simple hollow item . 44 8.12 Balance for load dryness test 45 9 Test programme

23、 46 10 Test methods . 47 10.1 General requirements on technical tests 47 10.2 Air leakage test 48 10.3 Dynamic sterilizer chamber pressure test 49 10.4 Empty chamber test 50 10.5 Solid load test 50 10.6 Narrow lumen test . 50 10.7 Simple hollow item test . 51 10.8 Small porous load test 52 10.9 Full

24、 porous load test (single and double wrapped) . 53 10.10 Small porous items test (single and double wrapped) 54 10.11 Solid load dryness test . 54 10.12 Porous load dryness test (small and full, single and double wrapped) 55 10.13 Small porous items dryness test (single and double wrapped) . 56 10.1

25、4 Non-condensable gases test 56 10.15 Microbiological test for solid loads . 60 10.16 Microbiological test for narrow lumens 60 10.17 Microbiological test for simple hollow item 60 10.18 Microbiological test for small porous loads . 61 10.19 Microbiological test for full porous loads . 61 10.20 Micr

26、obiological test for small porous items . 62 Annex A (informative) Clarification of the definition of narrow lumens and simple hollow items (see 3.18 and 3.30) . 63 Annex B (informative) Process evaluation system 65 Annex C (informative) Suggested maximum limits of contaminants in and specification

27、for water for steam sterilization . 66 Annex D (informative) Example of a table to be supplied with pre-purchase documentation and with the instructions for use 67 Annex E (informative) Load support systems 68 Annex F (informative) Rationale for the tests 69 Annex G (informative) Example of a proces

28、s challenge device for narrow lumen 72 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42 EEC on medical devices . 73 Bibliography 77 DIN EN 13060:2015-03 EN 13060:2014 (E) 4 Foreword This document (EN 13060:2014) has been prepared

29、 by Technical Committee CEN/TC 102 “Sterilizers for medical purposes”, 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 or by endorsement, at the latest by June 2015 and conflicting national s

30、tandards shall be withdrawn at the latest by December 2015. 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 E

31、N 13060:2004+A2:2010. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of

32、 this document. The following amendments have been made in comparison with EN 13060:2004+A2:2010: a) The scope of the standard has been revised with the aim to define small and large sterilizers on the chamber volume; b) Normative references, terms and definitions have been updated, e.g. term “hollo

33、w load A” has been changed to become “narrow lumen” ( 3.18) term “hollow load B” has been changed to become “simple hollow items” ( 3.30) c) In Clause 4 various sub-clauses and relevant requirements have been added, such as: General requirements for design and construction (4.3.1), Vibrations (4.3.5

34、) Noise (4.3.6) Steam penetration test (4.5.1.6) Software (4.5.4); d) Sub-clause 4.8 has been divided into two subsections: 4.8 Information to be provided 4.9 Marking e) Requirements in 5.3 on Attainment of the sterilization conditions have been revised; f) Requirements in Clause 6 Safety, risk cont

35、rol and usability have been revised, e.g. requirements on electromagnetic compatibility (EMC), Pressure Equipment and risk control were added g) Requirements on Sound power level (7.2.6) were added; DIN EN 13060:2015-03 EN 13060:2014(E)5 h) Requirements in 8.6 Porous load have been revised; i) Requi

36、rements for Process challenge device (PCD) and chemical indicators for products with narrow lumen were revised; j) Annex A has been revised, e.g. the defined hollow load A and B replaced by products with narrow lumen or simple hollow items; k) Example for process challenge device for narrow lumen (P

37、CD) has been moved to a new Annex G. l) Annex ZA including Table ZA.1 on medical device directive and Table ZA.2 on machinery directive have been updated due to the changes made in the standard; m) Standard has been editorially revised; n) Updated Bibliography. According to the CEN-CENELEC Internal

38、Regulations, 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Irelan

39、d, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. DINEN 13060:2015-03EN 13060:2014(E)6 Introduction Small steam sterilizers are widely used for medical purposes, e.g. in gener

40、al medical practice, dentistry, podiatry, facilities for personal hygiene and beauty care and also veterinary practice. They are also used for materials and equipment which are likely to come into contact with blood or bodily fluids, e.g. implements used by beauty therapists, tattooists, body pierce

41、rs and hairdressers. The specific nature of such sterilization loads used within these fields of application call for different performance requirements for the sterilization cycles and hence different corresponding test methods. This European Standard specifies the general requirements for small st

42、eam sterilizers and associated test methods. Performance is defined by reference to standard test loads. These are used to define a basic minimum performance and are not necessarily related to specific medical devices. It is the responsibility of the user and the manufacturer of the device to be ste

43、rilized to determine that any particular cycle is suitable for sterilizing a particular device. The performance tests specified in this standard can also be used by the manufacturer of the device to be sterilized to specify the appropriate performance for decontamination processes according to the r

44、equirements for information to be given by medical device manufacturers according to EN ISO 17664. This will enable users to identify the specific sterilizer performance required to safely process their devices. The performance requirements specified in this document are not intended for the process

45、 to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. However, some national regulations require the use of modified steam processes as part of a general prion decontamination programme. I

46、t is essential that the sterilizer and associated equipment is used only for the sterilization of the type of products for which it is designed. The choice of sterilizer, sterilization cycle or quality of services provided can be inappropriate for a particular product. Therefore the suitability of a

47、 sterilization procedure for a particular product needs to be verified by validation (see EN ISO 17665-1). DIN EN 13060:2015-03 EN 13060:2014(E)7 1 Scope This European Standard specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used

48、 for medical purposes or for materials that are likely to come into contact with blood or body fluids. This European Standard applies to automatically controlled small steam sterilizers that generate steam using electrical heaters or use steam that is generated by a system external to the sterilizer. This European Standard applies to small steam sterilizers used primarily for the sterilization of medical devices with a chamber volume of less than 60 l and unable to accommodate a sterilization module (300 mm 300 mm 600 mm). T