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

1、September 2014 Translation by DIN-Sprachendienst.English price group 24No 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).

2、ICS 11.080.10!%:nl“2237573www.din.deDDIN EN 14180Sterilizers for medical purposes Low temperature steam and formaldehyde sterilizers Requirements and testing;English version EN 14180:2014,English translation of DIN EN 14180:2014-09Sterilisatoren fr medizinische Zwecke Niedertemperatur-Dampf-Formalde

3、hyd-Sterilisatoren Anforderungen und Prfung;Englische Fassung EN 14180:2014,Englische bersetzung von DIN EN 14180:2014-09Strilisateurs usage mdical Strilisateurs la vapeur et au formaldhyde basse temprature Exigences et essais;Version anglaise EN 14180:2014,Traduction anglaise de DIN EN 14180:2014-0

4、9SupersedesDIN EN 14180:2010-01www.beuth.deDocument comprises 65 pagesIn case of doubt, the German-language original shall be considered authoritative.08.14 DIN EN 14180:2014-09 2 A comma is used as the decimal marker. National foreword This document (EN 14180:2014) has been prepared by Technical Co

5、mmittee CEN/TC 102 “Sterilizers for medical purposes” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-04-02 AA Niedertemperatur-Sterilisatoren. The DIN Standards correspo

6、nding to the International Standards referred to in this document are as follows: ISO 3781 DIN ISO 3781 ISO 8787 DIN ISO 8787 Amendments This standard differs from DIN EN 14180:2010-01 as follows: a) normative references have been updated; b) new terms and definitions have been added: “3.31 risk ass

7、essment”, “3.32 risk control”, “3.33 software validation” and “3.50 verification”; c) Subclause 4.1.4 “Heating and insulating the sterilizer chamber”, has been added; d) Subclauses 4.2.1 “Risk control and usability”, 4.2.3 “Pressure equipment”, 4.2.8 “Accessories” and 4.2.9 “Transport” have been add

8、ed; e) the requirements in Subclause 4.2.2 “Safety” have been revised; f) Subclause 5.2 “Software verification and validation” has been added; g) Clause 7 “Sound power and vibration” has been added; h) Clause 8 “Packaging, marking and labelling” has been revised to include further requirements; i) C

9、lause 9 “Information to be supplied by the manufacturer” has been revised; j) testing for sound power has been updated; k) Annex ZA “Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices” including Tables ZA.1 and ZA.2 has been update

10、d; l) the standard has been editorially revised. Previous editions DIN 58948-12: 1988-03 DIN 58948-13: 1987-01 DIN 58948-15: 1989-10 DIN EN 14180: 2003-10, 2010-01 DIN EN 14180:2014-09 3 National Annex NA (informative) Bibliography DIN ISO 3781, Paper and board Determination of tensile strength afte

11、r immersion in water DIN ISO 8787, Testing of paper and board Determination of capillary rise; Klemm method DIN EN 14180:2014-09 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 14180 May 2014 ICS 11.080.10 Supersedes EN 14180:2003+A2:2009English Version Steril

12、izers 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-Dampf-Formaldehyd-Sterilis

13、atoren - 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 any alteration. Up-to-da

14、te 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

15、 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, For

16、mer 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 FOR STANDARDIZATION COMIT

17、 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 EEN 14180:2014 (E) 2 Contents Page Foreword .

18、 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 5.1 General . 22 5.2 Software verificatio

19、n 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 Packaging, marking and labelling . 28 9 Info

20、rmation 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 environment 33 10.9 Lighting 33 Annex Test metho

21、ds . 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 medical devices 49 Annex F (informative) Environmental as

22、pects . 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 DIN EN 14180:2014-09 (normative)AEN 14180:2014 (E) 3 Foreword This document (EN 14180:2014) has been prepared by Technical Co

23、mmittee 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 and conflicting national standards sha

24、ll 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. This document supersedes EN 14180:2003

25、+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, which is an integral part of this docume

26、nt. 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 biological testing with method from

27、 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 Tables ZA1 and ZA2 were updated. Accor

28、ding 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 Republic of Macedonia, France, Germany,

29、 Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. DIN EN 14180:2014-09 EN 14180:2014 (E) 4 Introduction This European Standard specifies minim

30、um 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 can also be used during the comm

31、ercial 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 be applicable to validation an

32、d 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 processes are given in EN ISO 25424. A

33、t 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 recommendations have been produced in pa

34、rticular 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 the product during its life-cyc

35、le. 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. DIN EN 14180:2014-09 EN 14180:2014 (E) 5 1 Scope This European Stan

36、dard 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 medical devices in health care

37、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 routine control of the steriliza

38、tion 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 the referenced document (inc

39、luding 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 testing for small sterilizers

40、 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 2: Tolerances EN 60751:200

41、8, 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, Safety requirements for elect

42、rical 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: G

43、eneral 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 1: Designation system and

44、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) DIN EN 14180:2014-09 EN 14180:2014 (E)

45、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 formaldehyde sterilizatio

46、n 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 supplied - Part 1: General

47、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 aeration part of the sterili

48、zation 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 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 operatin