1、August 2014Translation by DIN-Sprachendienst.English price group 18No 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!%:,d“2230965www.din.deDDIN EN 1422Sterilizers for medical purposes Ethylene oxide sterilizers Requirements and test methods;English version EN 1422:2014,English translation of DIN EN 1422:2014-08Sterilisatoren fr medizinische Zwecke Ethylenoxid-Sterilisatoren Anforderungen und Prfverfahren
3、;Englische Fassung EN 1422:2014,Englische bersetzung von DIN EN 1422:2014-08Strilisateurs usage mdical Strilisateurs loxyde dthylne Exigences et mthodes dessai;Version anglaise EN 1422:2014,Traduction anglaise de DIN EN 1422:2014-08SupersedesDIN EN 1422:2009-08www.beuth.deIn case of doubt, the Germa
4、n-language original shall be considered authoritative.Document comprises 51 pages07.14 DIN EN 1422:2014-08 2 A comma is used as the decimal marker. National foreword This document (EN 1422:2014) has been prepared by Technical Committee CEN/TC 102 “Sterilizers for medical purposes” (Secretariat: DIN,
5、 Germany). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-04-02 AA Niedertemperatur-Sterilisatoren. Amendments This standard differs from DIN EN 1422:2009-08 as follows: a) Clause 1 “Scope” has been revi
6、sed: requirements and test methods for automatically controlled sterilizers employing ethylene oxide (EO) gas have been re-specified, in particular those used for the sterilization of heat labile medical devices (for example, explicit exclusion of sterilizers which employ the injection of EO or mixt
7、ures containing EO directly into packages or into a flexible chamber and removal of different types A and B of EO-sterilizers); b) normative references and the Bibliography have been revised and updated; c) Clause 3 “Terms and definitions” has been revised: “3.12 indicating”, “3.14 monitoring” and “
8、3.20 recording” as well as further terms and definitions of ISO/TS 11139, prEN ISO 11135 and EN ISO 14971 have been added; d) Clause 4 “Symbols and abbreviations” has been deleted; e) the standard has been restructured on the lines of ISO 11135 and EN 14180; f) requirements (in particular safety req
9、uirements for machinery) have been revised (see Annex ZA); g) Clause 4 “Technical requirements” has been revised (e.g. requirements for risk assessment (new), materials, sterilizer chambers, design, construction and measuring systems); h) Clause 5 “Process control” has been revised (e.g. requirement
10、s for software verification and validation (new), sterilization cycle, automatic controller); i) Clause 6 “Performance requirements” has been revised (e.g. requirements for sterilizing performance, EO removal and aeration); j) Clause 8 “Packaging, marking and labelling” and Clause 9 “Information to
11、be supplied by the manu-facturer” have been brought in line with the essential requirements of Directive 93/42/EEC on medical devices; k) the former Clauses 19 “Safety” and 20 “Storage and transport” have been deleted; l) Annex A “Test instrumentation” and Annex E “Environmental aspects” have been i
12、ncluded; m) Annex B “Leak test cycle” has been completely revised; n) the former Annexes A “Suggested maximum values of steam contaminants”, B “Steam quality tests”, D “Sound power test” and G “Temperature recording equipment for test purposes” have been deleted; o) Annex ZA (informative) “Relations
13、hip between this European Standard and the Essential Requirements of EU Directive 93/42/EEC” has been updated; Previous editions DIN 58948-1: 1977-01, 1986-12, 1988-06 DIN 58948-2: 1982-07, 1987-10 DIN 58948-3: 1976-03, 1982-09, 1987-10 DIN 58948-5: 1982-02, 1989-10 DIN 58948-6: 1982-07, 1987-10 DIN
14、 EN 1422: 1997-11; 2009-08 EN 1422May 2014 ICS 11.080.10 Supersedes EN 1422:1997+A1:2009English Version Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods Strilisateurs usage mdical - Strilisateurs loxyde dthylne - Exigences et mthodes dessai Sterilisatoren
15、 fr medizinische Zwecke - Ethylenoxid-Sterilisatoren - Anforderungen und Prfverfahren This European Standard was approved by CEN on 17 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
16、a national 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).
17、 A version 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, Cy
18、prus, Czech Republic, Denmark, 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 K
19、ingdom. 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 1422:2014 EEUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NOR
20、MUNGEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORM2 Contents PageForeword . 4 Introduction 5 1 Scope . 6 2 Normative references . 6 3 Terms and definitions . 7 4 Technical requirements 12 4.1 General . 12 4.1.1 Risk control and usability 12 4.1.2 Materials . 13 4.2 Sterilizer chamber . 13 4.2.1 Cha
21、mber size . 13 4.2.2 Doors, closures and interlocks of the sterilizer chamber 13 4.2.3 Test connections . 14 4.3 Design and construction 15 4.3.1 General . 15 4.3.2 EO vaporizers 15 4.3.3 Pipework and fittings 15 4.3.4 Evacuation system 15 4.3.5 Control valves . 16 4.3.6 Thermal insulation 16 4.3.7
22、Electrical and mechanical safety . 16 4.3.8 Air or inert gas filter 16 4.3.9 Emission control . 16 4.3.10 Framework and panelling . 17 4.3.11 Loading equipment . 17 4.3.12 Transport . 17 4.4 Indicating, measuring, and recording instruments . 17 4.4.1 General . 17 4.4.2 Temperature sensor 18 4.4.3 Te
23、mperature indicating instruments. 18 4.4.4 Pressure sensors 19 4.4.5 Timers and time indicating instruments . 19 4.4.6 Sterilizing cycle counter . 19 4.4.7 Relative humidity (RH) sensors . 19 4.4.8 Ethylene Oxide (EO) concentration-measurement 19 4.4.9 Recording instruments . 20 4.4.10 Indicating in
24、struments . 21 5 Process control . 22 5.1 General . 22 5.2 Software verification and validation . 23 5.3 Sterilization cycle and automatic control . 23 5.3.1 Automatic control . 23 5.3.2 Sterilization cycle 24 5.4 Override of automatic control 27 5.5 Fault 27 6 Performance requirements 28 DIN EN 142
25、2:2014-08EN 1422:2014 (E) 3 6.1 Sterilizing performance 28 6.1.1 Loading configuration 28 6.1.2 Physical parameters . 28 6.1.3 Microbiological efficacy . 28 6.2 EO removal (flushing) . 29 6.3 Aeration 29 7 Sound power . 29 8 Packaging, marking and labelling . 29 9 Information to be supplied by the m
26、anufacturer . 30 10 Service and local environment 32 10.1 General . 32 10.2 Electricity . 33 10.3 Sterilant 33 10.4 Circulation systems 33 10.5 Steam . 33 10.6 Water 34 10.7 Air and inert gasses 34 10.8 Drainage and discharges . 34 10.9 Ventilation and environment 34 10.10 Lighting 34 Annex A (norma
27、tive) Test instrumentation . 35 Annex B (normative) Leak test cycle . 36 Annex C (normative) Sterilizer chamber profile testing. 37 C.1 Sterilizer chamber internal surfaces . 37 C.2 Empty sterilizer chamber . 37 Annex D (normative) Microbiological test for EO sterilizers . 38 D.1 General . 38 D.2 Te
28、st equipment 38 D.3 Procedure 39 D.4 Interpretation of results 40 Annex E (informative) Environmental aspects . 41 E.1 Environmental aspects regarding the life cycle of EO sterilizers 41 E.2 EO (brief description) . 41 E.3 Environmental impact 41 Annex ZA (informative) Relationship between this Euro
29、pean Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices 44 Bibliography . 48 DIN EN 1422:2014-08EN 1422:2014 (E)4 Foreword This document (EN 1422:2014) has been prepared by Technical Committee CEN/TC 102 “Sterilizers for medical purposes”, the secretariat of which i
30、s 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 shall be withdrawn at the latest by May 2017. Attention is drawn to the possibility
31、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 1422:1997+A1:2009. This document has been prepared under a mandate given to CEN by the European
32、Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. Annexes A, B, C and D are normative and form part of this European Standard. Annexes E an
33、d ZA are for information only. The standard is a full technical revision of the previous version. The following amendments have been made in comparison with EN 1422:1997+A1:2009: new specification of the scope of the standard, e.g. explicit exclusion of sterilizers which employ the injection of EO o
34、r mixtures containing EO directly into packages or into a flexible chamber and removal of different types A and B of EO-sterilizers ; normative references have been updated; layout of the standard brought in line with the standard for LTSF-sterilization (EN 14180); the additional requirements from t
35、he machinery directive, introduced by the revision of the medical devices directive 2007/47/EC have been addressed (see revised Annex ZA), i.e. update of technical requirements and Tables ZA.1 and ZA.2; requirements have been rephrased to be performance requirements instead of design requirements; a
36、ddition of an environmental checklist; Annex B has been thoroughly revised and Annex D has been deleted. 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, Croat
37、ia, Cyprus, Czech Republic, Denmark, 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 th
38、e United Kingdom. DIN EN 1422:2014-08EN 1422:2014 (E) 5 Introduction Ethylene oxide (EO) sterilizers employing EO gas as the sterilant, either as a pure gas or in admixture with other gases, are primarily used for the sterilization of heat labile material or product. The EO-sterilizer specified in t
39、his European standard can be used for medical, dental, pharmaceutical veterinary and industrial or related purposes. The tests described in this European Standard are reference tests intended for use in demonstrating conformity with the performance requirements specified in this European Standard. T
40、hey can be used in type tests, works tests, in validation and re-validation tests, or in periodic and routine tests carried out by the user. Validation and routine control of sterilization processes are essential to ensure their efficacy. This European Standard does not cover validation and routine
41、control of EO processes (see prEN ISO 11135:2012). EO is a highly reactive chemical which can present a toxic, flammable or explosive hazard if incorrectly handled (see Annex E). The performance requirements specified in this document are not intended for the process to be effective in inactivating
42、the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld-Jakob disease. Planning and design of products complying with this standard should consider not only technical issues but also the environmental impact from the product during its lif
43、e-cycle. Environmental aspects are addressed in Annex E of this standard. By performing tests concurrently and/or in a logical sequence, the total number of tests carried out and waste arising from such tests, is reduced. As a result the burden on the environment can be reduced (see also Annex E). D
44、IN EN 1422:2014-08EN 1422:2014 (E)6 1 Scope This European Standard specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases, being used for the sterilization of me
45、dical devices and their accessories. This European Standard specifies requirements for ethylene oxide sterilizers (EO-sterilizers) working at super or sub-atmospheric pressure for: the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices; the equ
46、ipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes. The test loads described in this European Standard are selected to represent a number of loads for the evaluation of the performance of EO sterilizers for medical devices. Howeve
47、r, specific loads may require the use of other test loads. This European Standard does not specify those tests which are necessary to determine the probability of a processed product being sterile, nor the routine quality control tests required prior to release of sterile product. These topics are a
48、ddressed in prEN ISO 11135:2012. This European Standard does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities. NOTE 1 For further information on safety, see examples in the Bibliography. National or regional regulations can exis
49、t. This European Standard does not cover sterilizers which employ the injection of EO or mixtures containing EO directly into packages or into a flexible chamber. NOTE 2 See EN ISO 14937. This European Standard is not intended as a checklist for suitability of an existing EO sterilizer when assessing compliance with prEN ISO 11135:2012. This standard is not intended to be applied retrospectively. This European Standard does not cover analytical metho
