EN 285-2015 en Sterilization - Steam sterilizers - Large sterilizers《灭菌 蒸汽消毒器 大型杀菌器》.pdf

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1、BSI Standards PublicationBS EN 285:2015Sterilization Steamsterilizers Large sterilizersBS EN 285:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 285:2015.It supersedes BS EN 285:2006+A2:2009 which is withdrawn.The UK participation in its preparation was ent

2、rusted to TechnicalCommittee CH/198, Sterilization and Associated Equipment andProcesses.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

3、its correctapplication. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 82033 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

4、Strategy Committee on 31 January 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS EN 285:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 285 December 2015 ICS 11.080.10 Supersedes EN 285:2006+A2:2009English Version Sterilization - Steam sterilizers - Large s

5、terilizers 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 the CEN/CENELEC Internal Regulations which stipulate the condit

6、ions 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 Management Centre or to any CEN member. This European Standard exists

7、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 status as the official versions. CEN members are the national standa

8、rds 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, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slov

9、enia, 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 All rights of exploitation in any form and by any means reserved

10、 worldwide for CEN national Members. Ref. No. EN 285:2015 EBS EN 285:2015EN 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 Dimensions . 18 4.2 Materials 18 4.3 Pressure vessel . 18 4

11、.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 Steam source 23 5.2.1 Steam supply from a dedicated st

12、eam 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 system 24 6.3 Status indicators . 27 6.4 Measuring c

13、hains 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 control and indicating equipment 29 6.5 Recording

14、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 BS EN 285:2015EN 285:2015 (E) 3 8.1 Steam penetration 34 8.2 Physical parameter

15、s 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, textiles . 38 8.3.3 Load dryness, metal load . 38 9 Sound p

16、ower 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 environment . 41 13.1 General . 41 13.2 Electrical su

17、pply 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, except water specified in 13.3.6 42 13.6 Compressed air

18、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 Apparatus 46 15.3 Procedure 46 16 Thermometric tests . 47 16.1

19、 Small load, thermometric 47 16.1.1 General . 47 16.1.2 Apparatus 47 16.1.3 Procedure 48 BS EN 285:2015EN 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 17.1 General . 51 17.2 Apparatus 52 17.3 Procedure 52 18

20、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, small load 53 19.2.1 Apparatus 53 19.2.1.7 Connected service

21、s 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 sterilizer chamber pressure to rise more than 1,1 kPa/min re-ad

22、just 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 General . 57 20.1.2 Apparatus 57 20.1.3 Procedure 57 20.2

23、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 21.1.1 General . 60 21.1.2 Apparatus 60 21.1.3 Procedure

24、61 21.2 Dryness 63 21.2.1 General . 63 BS EN 285:2015EN 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 General . 69 21.4.2 Apparatus 69 21.4.3 Procedure 69 22 Rate of

25、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 instruments 75 23.3.3 Temperature instruments . 76 23.3.4 Reco

26、rding 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) Environmental aspects . 85 Annex B (informative) Suggested maximu

27、m 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 included in the instructions for use supplied with a sterilizer

28、 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 Directive 93/42/EEC on medical devices 95 Bibliography 100 BS EN 285

29、:2015EN 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+A2:2009. This European Standard shall be given the status of a na

30、tional 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 mandate given to CEN by the European Commission and the European Fr

31、ee 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 the previous version. The following amendments have been made in com

32、parison 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 substances or substances which could cause combustion, and equipment intend

33、ed 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 chain” “operating cycle stage”, “pressure”, “risk assessment”, “ris

34、k 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; Clause 6 on measuring system, indicating and recording devices c

35、ompletely 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; requirements on packaging and marking (Clause 12) revised and extended;

36、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; clauses on documentation and information revised and extended; BS EN 2

37、85:2015EN 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 93/42/ECC on Medical Devices including Tables ZA.1 and ZA.2 completely

38、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 any or all such patent rights. According to the CEN/CENELEC Internal Re

39、gulations, 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,

40、 Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 285:2015EN 285:2015 (E) 8 Introduction This European Standard specifies test procedures and acceptance criteria to confir

41、m whether the sterilizer is safe and can deliver an operating cycle for sterilizing the range of medical devices and loading configurations used in healthcare. It can also be used in other manufacturing sectors and industries. In addition, national regulations can necessitate consideration of the im

42、pact the sterilizer could have on the environment. A steam sterilization process uses water in its liquid and vaporous state to penetrate as steam into the load and to condense on the surfaces of a device. The distribution of moisture and temperature throughout the sterilization load and the process

43、 of sterilization itself cannot be measured directly for each routine sterilization process. This is done by comparison of measurement results with cycle parameters shown previously by validation to deliver an efficient sterilization process to the exposed medical devices. An instruction manual supp

44、lied with the sterilizer is required to have comprehensive information on the sterilizer, programmed operating cycles and safe operation. Requirements for the validation and routine control of sterilization are not addressed as they are specified EN ISO 17665-1. Medical devices used in health care c

45、an differ in properties such as materials, mass, shape, volume and packaging. Each sterilizer load can comprise a variable number of packages each containing different types of variably distributed medical devices. The reproducibility of the sterilization process can be affected by this variability

46、and also by other changes which can include: deviation of the defined cycle parameters, retention of air in the load, air leakage and non-condensable gases in the steam, excessive accumulation of non-condensable gases and/or condensate, overheating of the steam, selection of an inappropriate operati

47、ng cycle, and orientation of the load. The state “sterile” is specified in EN 556-1. For the steam sterilization in health care national regulations and the European Pharmacopoeia require or recommend combinations of minimum process parameters to produce a substantial overkill. This European Standar

48、d identifies combinations of sterilization temperatures and holding times, with tolerances, recommended by the “Working Party on Pressure-steam Sterilisers”1). The use of these values is justified when also considering the variable characteristics of sterilizer loads in healthcare. Process variables

49、 and process parameters as defined in EN ISO 17665-1 characterize the microbicidal effectiveness of the sterilization process. Cycle parameters are associated with the control of the operating cycle and have implications on the attainment of process parameters, the uniformity of steam penetration, the removal of air, drying and deterioration of medical devices and their packaging. 1) Working Party on Pressure-steam Sterilisers (JW Howie, Allison VD, JH Bowie, Darmady EM, Knox R, EJK Penikett, Shone JAV, Sykes G, Weir CD, W