DIN EN 285-2016 Sterilization - Steam sterilizers - Large sterilizers German version EN 285 2015《灭菌 蒸汽灭菌器 大型灭菌器 德文版本EN 285-2015》.pdf

1、May 2016 English price group 31No 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 11.080.10!%UVs“2505180www.din.deDIN

2、EN 285Sterilization Steam sterilizers Large sterilizers;English version EN 285:2015,English translation of DIN EN 285:2016-05Sterilisation Dampf-Sterilisatoren Gro-Sterilisatoren;Englische Fassung EN 285:2015,Englische bersetzung von DIN EN 285:2016-05Strilisation Strilisateurs la vapeur deau Grands

3、 strilisateurs;Version anglaise EN 285:2015,Traduction anglaise de DIN EN 285:2016-05SupersedesDIN EN 285:2009-08www.beuth.deDocument comprises 106 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.05.16 DIN EN 285:2016-05 2 A co

4、mma is used as the decimal marker. National foreword This document (EN 285:2015) has been prepared by Technical Committee CEN/TC 102 “Sterilizers for medical purposes” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Materialprfung (DIN Sta

5、ndards Committee Materials Testing), Working Committee NA 063-04-01 AA Dampf-Sterilisatoren. This standard contains specifications giving detail to the essential requirements set out in EU Directive 93/42/EEC on medical devices. Amendments This standard differs from DIN EN 285:2009-08 as follows: a)

6、 an Introduction has been implemented; b) the scope has been modified to differentiate small and large sterilizers by chamber size and to exclude equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion, and equipment intended to process pat

7、hogenic substances or human tissues; c) normative references and the Bibliography have been updated; d) terms and definitions have been improved, deleted or new definitions such as “cycle parameter”, “fault”, “maintenance”, “measuring chain”, “operating cycle stage”, “pressure”, “risk assessment”, “

8、risk control”, “services”, “sterilization process”, “software validation” and “verification” have been added; e) new Subclauses 4.3.1.3 “Protection at moving door”, 4.5 “Loading equipment“, 4.6 “Transport“ and 7.3 “Software verification and validation” have been added; f) Clause 6 “Measuring system,

9、 indicating and recording devices for temperature, pressure, time and status indicators” has been completely redrafted; g) the requirements for sound power and vibration have been completely redrafted; h) the requirements for safety, risk control and usability (Clause 11) have been completely redraf

10、ted including normative Annex F and reference to EN ISO 14971; i) the requirements for packaging and marking (Clause 12) have been revised and extended; j) the requirements for service and working environment (Clause 13) have been extended, e.g. 13.4 “Lighting” has been added and 13.7 “Electromagnet

11、ic interference” has been improved; k) the clause dealing with the sound power test has been deleted; l) the requirements for the test measurement equipment have been redrafted; m) the clauses dealing with documentation and information have been revised and extended; n) Annex A “Environmental aspect

12、s” has been redrafted; o) Annex C “Recommended material” has been deleted; p) a normative Annex F “Protective measures” has been added; q) Annex ZA including Table ZA.1 “Correspondence between this European Standard and Directive 93/42/EEC on medical devices” and Table ZA.2 “Relevant Essential Healt

13、h and Safety Requirements from Directive 2006/42/EC on machinery that are addressed by this European Standard” has been completely revised; r) the standard has been editorially revised. DIN EN 285:2016-05 3 Previous editions DIN 58946-2: 1972-08, 1977-01, 1982-08, 1982-10 Supplement 1 to DIN 58946-2

14、: 1973-11 Supplement 2 to DIN 58946-2: 1976-01 DIN 58946-3: 1981-11 DIN 58946-7: 1982-08 DIN EN 285: 1997-02, 2006-08, 2008-06, 2009-08 DIN EN 285:2016-05 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 285 December 2015 ICS 11.080.10 Supersedes EN 285:2006+A2

15、:2009English Version Sterilization - Steam sterilizers - Large sterilizers Strilisation - Strilisateurs la vapeur deau - Grands strilisateurs Sterilisation - Dampf-Sterilisatoren - Gro-Sterilisatoren This European Standard was approved by CEN on 15 November 2015. CEN members are bound to comply with

16、 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 references concerning such national standards may be obtained on application to the CEN-CENELEC Manage

17、ment 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 member into its own language and notified to the CEN-CENELEC Management Centre has the same stat

18、us 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta

19、, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN

20、All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 285:2015 EEN 285:2015 (E) 2 Contents Page European foreword . 6 Introduction 8 1 Scope . 11 2 Normative references . 11 3 Terms and definitions 12 4 Mechanical components 18 4.1 Dimension

21、s . 18 4.2 Materials 18 4.3 Pressure vessel . 18 4.3.1 General . 18 4.3.2 Double ended sterilizers . 18 4.3.3 Test connections . 19 4.3.4 Insulation 20 4.4 Framework and panelling . 21 4.5 Loading equipment 23 4.6 Transport 23 5 Piping system and components 23 5.1 Pipework and fittings . 23 5.2 Stea

22、m source 23 5.2.1 Steam supply from a dedicated steam generator . 23 5.2.2 Steam supply from a central source 24 5.3 Air filter . 24 5.4 Vacuum system . 24 6 Measuring system, indicating and recording devices for temperature, pressure, time and status indicators. 24 6.1 General . 24 6.2 Measuring sy

23、stem 24 6.3 Status indicators . 27 6.4 Measuring chains and time equipment 27 6.4.1 Temperature probes . 27 6.4.2 Temperature measuring chains for control, recording and indication . 28 6.4.3 Pressure transducers 28 6.4.4 Pressure measuring chains for control, recording and indication 28 6.4.5 Time

24、control and indicating equipment 29 6.5 Recording systems . 29 6.5.1 General . 29 6.5.2 Records 29 6.5.3 Data processing . 31 7 Control systems 32 7.1 General . 32 7.2 Fault indication system 33 7.3 Software verification and validation . 34 8 Performance requirements 34 DIN EN 285:2016-05EN 285:2015

25、 (E) 3 8.1 Steam penetration 34 8.2 Physical parameters 35 8.2.1 Temperature characteristics 35 8.2.2 Bowie and Dick test 37 8.2.3 Air leakage 37 8.2.4 Air detector . 37 8.2.5 Hollow load test . 37 8.3 Load dryness 37 8.3.1 Load dryness, small load, textiles . 37 8.3.2 Load dryness, full load, texti

26、les . 38 8.3.3 Load dryness, metal load . 38 9 Sound power and vibration. 38 9.1 Sound power . 38 9.2 Vibration 38 10 Rate of pressure change . 38 11 Safety, risk control and usability 39 11.1 Protective measures 39 11.2 Risk control, usability . 40 12 Packaging and marking 40 13 Service and working

27、 environment . 41 13.1 General . 41 13.2 Electrical supply 41 13.3 Steam supply to the sterilizer chamber 41 13.3.1 Non-condensable gases 41 13.3.2 Dryness value . 41 13.3.3 Superheat. 41 13.3.4 Contaminants . 41 13.3.5 Pressure fluctuation 42 13.3.6 Feed water . 42 13.4 Lighting . 42 13.5 Water, ex

28、cept water specified in 13.3.6 42 13.6 Compressed air 43 13.7 Electromagnetic interference 43 13.8 Drains 43 13.9 Working Environment 43 13.10 Service connections . 43 14 Testing 43 14.1 General . 43 14.2 Calibration . 45 14.3 Environment . 45 15 Hollow load test . 46 15.1 General . 46 15.2 Apparatu

29、s 46 15.3 Procedure 46 16 Thermometric tests . 47 16.1 Small load, thermometric 47 16.1.1 General . 47 16.1.2 Apparatus 47 16.1.3 Procedure 48 DIN EN 285:2016-05EN 285:2015 (E) 4 16.2 Full load, thermometric . 50 16.2.1 General . 50 16.2.2 Apparatus 50 16.2.3 Procedure 50 17 Bowie and Dick test . 51

30、 17.1 General . 51 17.2 Apparatus 52 17.3 Procedure 52 18 Air leakage test . 52 18.1 General . 52 18.2 Apparatus 52 18.3 Procedure 53 18.3.2 Stabilize the temperature of the sterilizer chamber by carrying out one of the following: . 53 19 Air detector tests 53 19.1 General . 53 19.2 Air detector, sm

31、all load 53 19.2.1 Apparatus 53 19.2.1.7 Connected services complying with Clause 13. . 54 19.2.2 Procedure 54 19.3 Air detector, full load 55 19.3.1 Apparatus 55 19.3.1.2 Thermometric recording instrument as described in 23.3.4.1. 55 19.3.2 Procedure 55 19.3.2.13 If the air leakage causes the steri

32、lizer chamber pressure to rise more than 1,1 kPa/min re-adjust the metering device to cause a pressure rise of (1,0 0,1) kPa/min 56 19.4 Air detector function . 56 19.4.1 General . 56 19.4.2 Apparatus 56 19.4.3 Procedure 56 20 Load dryness test . 57 20.1 Load dryness, small load, textiles 57 20.1.1

33、General . 57 20.1.2 Apparatus 57 20.1.3 Procedure 57 20.2 Load dryness, full load, textile . 58 20.2.1 General . 58 20.2.2 Apparatus 58 20.2.3 Procedure 58 20.3 Load dryness, metal 59 20.3.1 General . 59 20.3.2 Apparatus 59 20.3.3 Procedure 59 21 Steam quality test . 60 21.1 Non-condensable gases 60

34、 21.1.1 General . 60 21.1.2 Apparatus 60 21.1.3 Procedure 61 21.2 Dryness 63 21.2.1 General . 63 DIN EN 285:2016-05EN 285:2015 (E) 5 21.2.2 Apparatus 63 21.2.3 Procedure 64 21.3 Superheat. 67 21.3.1 General . 67 21.3.2 Apparatus 67 21.3.3 Procedure 67 21.4 Sampling of steam condensate . 69 21.4.1 Ge

35、neral . 69 21.4.2 Apparatus 69 21.4.3 Procedure 69 22 Rate of pressure change . 71 22.1 General . 71 22.2 Apparatus 71 22.3 Procedure 71 23 Test apparatus, equipment and material 71 23.1 Standard test pack 71 23.2 Reduced test pack . 74 23.3 Test instruments . 75 23.3.1 General . 75 23.3.2 Pressure

36、instruments 75 23.3.3 Temperature instruments . 76 23.3.4 Recording instruments . 77 23.4 Full load, textiles . 78 23.5 Test pack, metal 78 23.6 Metering device . 80 24 Documentation to be supplied with the sterilizer 81 25 Information to be supplied with the sterilizer. 81 Annex A (informative) Env

37、ironmental aspects . 85 Annex B (informative) Suggested maximum values of contaminants in feed water 88 Annex C (informative) Temperature and time tolerances during the small load thermometric test. 89 Annex D (informative) Guidance for installation and operational qualification tests which can be i

38、ncluded in the instructions for use supplied with a sterilizer 90 Annex E (informative) Criteria for identifying sterilizers as the same type 92 Annex F (normative) Protective measures . 93 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Direct

39、ive 93/42/EEC on medical devices 95 Bibliography 100 DIN EN 285:2016-05EN 285:2015 (E) 6 European foreword This document (EN 285:2015) has been prepared by Technical Committee CEN/TC 102 “Sterilizers for medical purposes”, the secretariat of which is held by DIN. This document supersedes EN 285:2006

40、+A2:2009. 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 2016, and conflicting national standards shall be withdrawn at the latest by December 2018. This document has been prepared under a m

41、andate 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 standard is a full technical revision of th

42、e previous version. The following amendments have been made in comparison with EN 285:2006+A2:2009: introduction has been implemented; scope was modified to differentiate small and large sterilizer by chamber size and to exclude equipment intended to use, contain or be exposed to flammable substance

43、s or substances which could cause combustion, and equipment intended to process pathogenic substances or human tissues; normative references and bibliography have been updated; terms and definitions improved, deleted or new definitions such as, “cycle parameter”, “fault”, “maintenance”, “measuring c

44、hain” “operating cycle stage”, “pressure”, “risk assessment”, “risk control”, “services”, “sterilization process”, “software validation” and “verification” added; new subclauses 4.3.1.3 Protection at moving door, 4.5 Loading equipment, 4.6 Transport and 7.3 Software verification and validation added

45、; Clause 6 on measuring system, indicating and recording devices completely redrafted; requirements on sound power and vibration completely redrafted; requirements on safety, risk control and usability (Clause 11) completely redrafted including normative Annex F and reference to EN ISO 14971; requir

46、ements on packaging and marking (Clause 12) revised and extended; requirements on service and working environment (Clause 13) extended, e.g. 13.4 Lighting added, 13.7 Electromagnetic interference improved; clause on sound power test deleted; requirements on test measurement equipment redrafted; clau

47、ses on documentation and information revised and extended; DIN EN 285:2016-05EN 285:2015 (E) 7 Annex A on environmental aspects redrafted; Annex C on recommended material deleted; normative Annex F on protective measures added; Annex ZA relationship with the essential requirements of the Directive 9

48、3/42/ECC on Medical Devices including Tables ZA.1 and ZA.2 completely revised editorial revision of whole document. 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 a

49、ny or all such patent rights. According to the CEN/CENELEC Internal Regulations, the national standards organisations 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, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,