EN 13060-2014 en Small steam sterilizers《小型蒸汽灭菌器》.pdf

1、BSI Standards PublicationBS EN 13060:2014Small steam sterilizersBS EN 13060:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 13060:2014. Itsupersedes BS EN 13060:2004+A2:2010 which is withdrawn.The UK participation in its preparation was entrusted to Technic

2、alCommittee CH/198, Sterilization of Medical Devices.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British

3、Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 78579 5ICS 11.080.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 December 20

4、14.Amendments issued since publicationDate Text affectedBS EN 13060:2014EUROPEAN 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-Klein-Sterilisatoren This E

5、uropean 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 bibliographical referenc

6、es 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 me

7、mber 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, F

8、rance, 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 NORMALISATION EUROPISCHES

9、 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 EBS EN 13060:2014EN 13060:2014 (E) 2 Contents Page Foreword 4 Introduction .6 1 Sc

10、ope 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 environment 27 4.

11、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 gases 35 6 S

12、afety, 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 equipment

13、. 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 wrapped 44

14、8.9 Solid load, double wrapped . 44 8.10 Process challenge device (PCD) and chemical indicator for narrow lumen 44 BS EN 13060:2014EN 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 46 10 Test me

15、thods . 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 porous load t

16、est (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 10.14 Non-condensa

17、ble 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 Microbiological te

18、st 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 for water for

19、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 process challenge de

20、vice 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 BS EN 13060:2014EN 13060:2014 (E) 4 Foreword This document (EN 13060:2014) has been prepared by Technical Commi

21、ttee 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 standards shall be w

22、ithdrawn 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 EN 13060:2004+A2:201

23、0. 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 this document. The

24、 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 “hollow load A” has been

25、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) Noise (4.3.6) Ste

26、am 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 control and usability h

27、ave 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; BS EN 13060:2014EN 13060:2014 (E) 5 h) Requirements in 8.6 Porous load have been revised; i) Requirements for Process ch

28、allenge 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 (PCD) has been moved to

29、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 Regulations, the natio

30、nal 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, Ireland, Italy, Latvia, Lith

31、uania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 13060:2014EN 13060:2014 (E) 6 Introduction Small steam sterilizers are widely used for medical purposes, e.g. in general medical practice, de

32、ntistry, 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 piercers and hairdressers. Th

33、e 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 steam sterilizers and ass

34、ociated 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 sterilized to determine th

35、at 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 requirements for informa

36、tion 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 to be effective in ina

37、ctivating 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. It is essential that the

38、 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 sterilization procedur

39、e for a particular product needs to be verified by validation (see EN ISO 17665-1). BS EN 13060:2014EN 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 for medical purposes or f

40、or 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 a

41、pplies 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). The requirements concerning the quality management and risk management are addressed by other sta

42、ndards (e.g. EN ISO 13485, EN ISO 14971). This European Standard does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products. This European Standard does not specify safety requirements related to risks associated with the zone in which the sterilizer is u

43、sed (e.g. flammable gases). This European Standard does not specify requirements for the validation and routine control of sterilization by moist heat. NOTE Requirements for the validation and routine control of sterilization by moist heat are given in EN ISO 17665-1. This European Standard does not

44、 specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide). 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application.

45、For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. prEN 285:20141), Sterilization Steam sterilizers Large sterilizers EN 285: 2006+A2:2009, Sterilization Steam sterilizers Large sterilizers E

46、N 867-5:2001, Non-biological systems for use in sterilizers Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S EN 868 (all parts), Packaging for terminally sterilized medical devices 2)EN 1041, Information

47、supplied by the manufacturer of medical devices EN 10088-1, Stainless steels Part 1: List of stainless steels 1) Under revision. 2) EN 868-1 has been replaced by EN ISO 11607-1. BS EN 13060:2014EN 13060:2014 (E) 8 EN 13060:2004+A2:2010, Small steam sterilizers EN 13445 (all parts), Unfired pressure

48、vessels EN 60529, Degrees of protection provided by enclosures (IP Code)(IEC 60529) EN 60751:2008, Industrial platinum resistance thermometers and platinum temperature sensors (IEC 60751:2008) EN 61010-1:2010, Safety requirements for electrical equipment for measurement, control, and laboratory use

49、Part 1: General requirements (IEC 61010-1:2010) EN 61010-2-040:2005, Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials (IEC 61010-2-040:2005) EN 61326-1:2013, Electrical equipment for measurement, control and laboratory use EMC requirements Part 1: General requirements (IEC 61326-1:2012) EN ISO 228-1, Pipe threads where pressure-tight joints are not made on the threads Part 1: Dimensions, t