BS EN 14180-2014 Sterilizers for medical purposes Low temperature steam and formaldehyde sterilizers Requirements and testing《医用灭菌器 低温蒸汽和甲醛灭菌器 要求和试验》.pdf

1、BSI Standards PublicationBS EN 14180:2014Sterilizers for medical purposes Low temperature steam andformaldehyde sterilizers Requirements and testingBS EN 14180:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 14180:2014. It supersedes BS EN 14180:2003+A2:200

2、9 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee LBI/35, Sterilizers, autoclaves and disinfectors.A list of organizations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 ne

3、cessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2014.Published by BSI Standards Limited 2014ISBN 978 0 580 78885 7ICS 11.080.10Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard

4、 was published under the authority of the Standards Policy and Strategy Committee on 31 May 2014.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS EN 14180:2014EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 14180 May 2014 ICS 11.080.10 Supersedes EN 14180:2003+A2:200

5、9English Version Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing Strilisateurs usage mdical - Strilisateurs la vapeur et au formaldhyde basse temprature - Exigences et essais Sterilisatoren fr medizinische Zwecke - Niedertemperatur-Dam

6、pf-Formaldehyd-Sterilisatoren - Anforderungen und Prfung This European Standard was approved by CEN on 10 April 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 a

7、ny 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 langu

8、age 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

9、, Estonia, Finland, Former Yugoslav 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 FO

10、R STANDARDIZATION COMIT EUROPEN DE 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 14180:2014 EBS EN 14180:2014EN 14

11、180:2014 (E) 2 Contents Page Foreword . 3 Introduction 4 1 Scope . 5 2 Normative references . 5 3 Terms and definitions . 6 4 Technical requirements 11 4.1 Sterilizer chamber . 11 4.2 Design and construction 14 4.3 Indicating, measuring, operating and recording devices . 16 5 Process control . 22 5.

12、1 General . 22 5.2 Software verification and validation . 22 5.3 Operating cycle and automatic control 23 5.4 Override of automatic control 24 5.5 Fault 24 6 Performance requirements 25 6.1 Sterilizing performance 25 6.2 Desorption efficacy . 27 6.3 Drying . 27 7 Sound power and vibration 27 8 Packa

13、ging, marking and labelling . 28 9 Information to be supplied by the manufacturer . 29 10 Service and local environment 31 10.1 General . 31 10.2 Electricity . 31 10.3 Sterilant 31 10.4 Steam . 32 10.5 Water 32 10.6 Compressed air . 32 10.7 Drainage and discharges . 32 10.8 Ventilation and environme

14、nt 33 10.9 Lighting 33 Annex A (normative) Test methids . 34 Annex B (normative) Sterilizer classification and testing . 40 Annex C (normative) Test equipment 43 Annex D (normative) Determination of formaldehyde residuals in a filter indicator . 46 Annex E (informative) Formaldehyde residues on medi

15、cal devices 49 Annex F (informative) Environmental aspects . 51 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices 54 Bibliography . 60 BS EN 14180:2014EN 14180:2014 (E) 3 Foreword This document (EN 14180:201

16、4) has been prepared 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 November 2014 an

17、d conflicting national standards shall be withdrawn at the latest by November 2014. 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. Th

18、is document supersedes EN 14180:2003+A2:2009. 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, whic

19、h is an integral part of this document. The standard is a full technical revision of the previous version. The following amendments have been made in comparison to EN 14180:2003+A2:2009: normative references were updated; terms risk assessment, risk analysis and software validation were added; align

20、 biological testing with method from EN ISO 25424; requirements for heat isolation were updated; safety requirements, mainly as a consequence of compliance with the machinery directive were added; requirements and testing for sound power, also including vibration, were updated; Annex ZA including Ta

21、bles ZA1 and ZA2 were updated. According to the CEN-CENELEC Internal 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 Rep

22、ublic 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 the United Kingdom. BS EN 14180:2014EN 14180:2014 (E) 4 Introduction This Eu

23、ropean Standard specifies minimum requirements and test methods for sterilizers working below ambient atmospheric pressure performing a low temperature steam and formaldehyde (LTSF) process. LTSF sterilizers are primarily used for the sterilization of medical devices in health care facilities, but c

24、an also be used during the commercial production of medical devices. LTSF processes are specified by physical parameters and verified using physical, chemical and microbiological means 8. The sterilizers operate automatically using pre-set cycles. The test methods and test equipment given could also

25、 be applicable to validation and routine control. Validation and routine control of sterilization processes are essential to ensure their efficacy. This standard does not cover validation and routine control of a LTSF process. Criteria for validation and routine control of LTSF sterilization process

26、es are given in EN ISO 25424. At the present state of knowledge, LTSF sterilizers should not be assumed to deliver processes effectively inactivating the causative agents of spongiform encephalopathies such as scrapie, Bovine Spongiform Encephalopathy and Creutzfeld-Jakob Disease. Specific recommend

27、ations have been produced in particular countries for the processing of materials potentially contaminated with these agents. See also EN ISO 25424:2011, 1.2.1. Planning and design of products applying to this standard should consider not only technical issues but also the environmental impact from

28、the product during its life-cycle. Environmental aspects are addressed in Annex F of this standard. NOTE Specifications on operator safety are addressed in EN 610101, EN 610102040 and are not repeated in this standard. EN 602041 can also give valuable guidelines. BS EN 14180:2014EN 14180:2014 (E) 5

29、1 Scope This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only. These sterilizers are primarily used for the sterilization of heat labile medic

30、al devices in health care facilities. This European Standard specifies minimum requirements: for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices; for the equipment and controls of these sterilizers necessary for the validation and routin

31、e control of the sterilization processes. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of th

32、e referenced document (including any amendments) applies. EN 764-7, Pressure equipment - Part 7: Safety systems for unfired pressure equipment EN 8675, Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance tes

33、ting for small sterilizers Type B and Type S EN 8685, Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods EN 14222:2003, Stainless steel shell boilers EN 605842, Thermocouples Part

34、2: Tolerances EN 60751:2008, Industrial platinum resistance thermometers and platinum temperature sensors (IEC 60751:2008) EN 610101:2010, Safety requirements for electrical equipment for measurement, control and laboratory use Part 1: General requirements (IEC 61010-1:2010) EN 61010-2-040:2005, Saf

35、ety 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

36、EMC requirements Part 1: General requirements (IEC 61326-1:2012) EN ISO 228-1:2003, Pipe threads where pressure-tight joints are not made on the threads - Part 1: Dimensions, tolerances and designation (ISO 228-1:2000) EN ISO 1874-1, Plastics - Polyamide (PA) moulding and extrusion materials - Part

37、1: Designation system and basis for specification (ISO 1874-1) EN ISO 3746:2010, Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Survey method using an enveloping measurement surface over a reflecting plane (ISO 3746:2010) BS EN 14180:2

38、014EN 14180:2014 (E) 6 EN ISO 11138-1:2006, Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006) EN ISO 11138-5, Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and form

39、aldehyde sterilization processes (ISO 11138-5) EN ISO 14971:2012, Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) EN ISO 15223-1, Medical devices - Symbols to be used with medical device labels, labelling and information to be suppli

40、ed - Part 1: General requirements (ISO 15223-1) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 access device means used to enable access to restricted parts of equipment Note 1 to entry: This can be a dedicated key, code or tool. 3.2 aeratio

41、n part of the sterilization process during which sterilizing agent and/or its reaction products desorb from the medical device until predetermined levels are reached Note 1 to entry: This can be performed within the sterilizer and/or in a separate chamber or room. 3.3 air removal removal of air from

42、 the sterilizer chamber and sterilization load to facilitate sterilant penetration 3.4 automatic controller device that, in response to cycle parameters, operates the apparatus sequentially through the operating cycle(s) 3.5 biological indicator test system containing viable microorganisms providing

43、 a defined resistance to a specified sterilization process SOURCE: ISO/TS 11139:2006, 2.3 3.6 chamber pre-heating heating of inner sterilizer chamber surfaces to achieve predetermined temperatures prior to the commencement of a sterilization cycle 3.7 conditioning treatment of product within the ste

44、rilization cycle, but prior to the holding time, to attain a predetermined temperature, humidity and, if applicable, concentration throughout the sterilization load 3.8 cycle complete indication that the operating cycle has been completed according to programme and that the sterilized load is ready

45、for removal from the sterilizer chamber BS EN 14180:2014EN 14180:2014 (E) 7 SOURCE: EN 285:2006+A2:2009, 3.9 3.9 cycle parameter specified value for a cycle variable Note 1 to entry: The specification for a cycle includes the cycle parameters and their tolerances. 3.10 cycle variable physical proper

46、ty that influences the efficacy of the operating cycle Note 1 to entry: For LTSF-sterilizers, the cycle variables include, but are not necessarily limited to temperature, pressure, time, sterilant concentration. 3.11 desorption removal of the sterilant from the chamber and the load at the end of the

47、 exposure time 3.12 desorption indicator indicator, intended to determine the amount of sterilant residuals 3.13 double-ended sterilizer sterilizer in which there is a door at each end of the sterilizer chamber SOURCE: EN 285:2006+A2:2009, 3.11 3.14 exposure time period between introducing the steri

48、lant into the chamber and the start of the desorption phase 3.15 inoculated carrier supporting material on or in which a defined number of viable test organisms have been deposited SOURCE: EN ISO 11138-1:2006, 3.10 3.16 installation qualification IQ process of obtaining and documenting evidence that

49、 equipment has been provided and installed in accordance with its specification SOURCE: ISO/TS 11139:2006, 2.22 3.17 loading door door in a double ended sterilizer through which the load is put into the sterilizer chamber SOURCE: EN 285:2006+A2:2009, 3.17 Note 1 to entry: See also 3.47 unloading door. 3.18 LTSF-equilibration time period which elapses between the attainment of the sterilization temperature at the reference measurement point and the attainment of the sterilization temperature at all points within the loa