EN ISO 15883-1-2009 en Washer-disinfectors - Part 1 General requirements terms and definitions and tests (Incorporates Amendment A1 2014)《洗涤器消毒器 第1部分 一般要求 术语 定义和测试》.pdf

1、BS EN ISO15883-1:2009ICS 11.080.10NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDWasher-disinfectorsPart 1: General requirements,terms and definitions and tests (ISO15883-1:2006)+A1:2014National forewordThis British Standard is the UK implementation of EN ISO 1

2、5883-1:2009+A1:2014. It is identical to ISO 15883-1:2006, incorporating amendment 1:2014. It supersedes BS EN ISO 15883-1:2009 which is withdrawn.The start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indicating changes to ISO text carry the number of

3、the ISO amendment. For example, text altered by ISO amendment 1 is indicated by !“.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 sec

4、retary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.BS EN ISO 15883-1:2009+A1:2014This British Standardwas published underthe

5、 authority of theStandards Policy andStrategy Committee on 31October 2009Amendments/corrigenda issued since publicationDate Comments 30 September 2014 Implementation of ISO amendment 1:2014 with CEN endorsement A1:2014. Annex ZA updatedISBN 978 0 580 76590 2 The British Standards Institution 2014. P

6、ublished by BSI Standards Limited 2014EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMICS 11.080.10English VersionWasher-disinfectors - Part 1: General requirements, terms anddefinitions and tests (ISO 15883-1:2006)Laveurs dsinfecteurs - Partie 1: Exigences gnrales,termes et dfinitions et essais (ISO

7、 15883-1:2006)Reinigungs-Desinfektionsgerte - Teil 1: AllgemeineAnforderungen, Begriffe und Prfverfahren (ISO 15883-1:2006)This European Standard was approved by CEN on 16 May 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving thi

8、s EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (En

9、glish, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria,

10、 Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FORSTANDARDIZATIONCO

11、MIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FRNORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 15883-1:2009: EEN ISO 15883-1:2009+A1July 20143 Foreword The texto

12、fISO 15883-1:2006 has been prepared by Technical Committee ISO/TC 198 “Sterilization of healthcare products”ofthe International Organizationfor Standardization (ISO)and has been taken over as EN ISO 15883-1:2009 by Technical Committee CEN/TC102 “Sterilizersfor medical purposes” the secretariat of wh

13、ich is held by DIN.This European Standard shall be given the status of a national standard, either by publication of an identical textorbyendorsement, at the latestbyDecember 2009, and conflicting national standards shall be withdrawn at the latestbyMarch 2010. Attention is drawn to the possibilityt

14、hat some of the elements of this document maybethe subject of patent rights.CEN and/or CENELEC shallnot be held respo nsible for identifying anyorall such patent rights. This document supersedes EN ISO15883-1:2006.This document has been prepared under amandate given to CEN by the European Commission

15、 and the European Free Trade Association, and supports essential requirements of EC Directive.Forrelationship withECDirective, seeinformative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC InternalRegulations, the national standardsorganizations of the followingco

16、untriesare bound to implement this European Standard: Austria,Belgium,Bulgaria, Cyprus, CzechRepublic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,Lithuania, Luxembourg, Malta,Netherlands, Norway,Poland, Portugal, Romania, Slovakia, Slovenia, Spain, S

17、weden, Switzerland and the UnitedKingdom. Endorsement noticeThe textofISO 15883-1:2006 has been approved by CEN as a EN I SO 15883-1:2009 without anymodification.BS EN ISO 15883-1:2009+A1:2014 EN ISO 15883-1:2009+A1:2014 (E)4 This document (EN ISO 15883-1:2009/A1:2014) has been prepared by Technical

18、 Committee ISO/TC 198 “Sterilization of health care products” in collaboration with Technical Committee CEN/TC 102 “Sterilizers for medical purposes” the secretariat of which is held by DIN. This Amendment to the European Standard EN ISO 15883:2009 shall be given the status of a national standard, e

19、ither by publication of an identical text or by endorsement, at the latest by January 2015, and conflicting national standards shall be withdrawn at the latest by January 2015. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN a

20、nd/or CENELEC shall not be held responsible for identifying any or all such patent rights. 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

21、 Directive(s), see informative Annex ZA, which is an integral part of this document. 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 Re

22、public, 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 the United Kingdom. En

23、dorsement notice The text of ISO 15883-1:2006/Amd 1:2014 has been approved by CEN as EN ISO 15883-1:2009/A1:2014 without any modification. Foreword to amendment A1BS EN ISO 15883-1:2009+A1:2014 EN ISO 15883-1:2009+A1:2014 (E)5 Annex ZA (informative) Relationship between this European Standard and th

24、e Essential Requirements of EU Directive 93/42/EEC on medical devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/4

25、2/EEC on medical devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the sc

26、ope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC on medical devices Clauses/subclauses of this European Standard Essentia

27、l requirements (ERs)of EU Directive 93/42/EEC Qualifying remarks/Notes 4,5.2.1, 5.4.1.2, 5.5.1, 5.7, 5.24, 5.25, 6.10, 6.11, 6.12, 9.2 7.2 Including reference to EN 610102-040:2005, 5.4.4 b), e), f), 5.4.5 and 5.4101 4.6, 5.1, 5.2, 5.7, 6.9 7.3 Including reference to EN 610102-040:2005, 5.4.3 k), m)

28、, 11.1 and 11.2 5.1.7, 5.1.8, 5.2, 5.4, 5.4.1.2, 5.4.5.3, 6.5.3, 5.24, 5.25, 8.2 g), and h), 10 c) 7.5 Including reference to EN 610102-040:2005, 5.2, 11.3 and 11.4 4.5.3, 4.5.4, 5.3.2, 5.26, 6.11 7.6 Including reference to EN 610102-040:2005, 5.3.4 and 11.101 4, 5.2, 5.3.1, 5.3.2, 5.4.3, 5.4.4, 5.5

29、.1, 5.24, 5.26, 6.1, 6.2, 6.11 8.1 3, 4, 5.1.11, 5.2, 8.1 b), 8.3 9.1 Including reference to EN 610102-040:2005, 5.4.3, Clause 14, ISO 14121:1999, EN ISO 14971:2013 and EN 615081:2010 4, 5.1, 5.1.5, 5.1.9, 5.2.1, 5.2.2, 5.2.3, 5.4.1.9, 5.4.2, 5.4.3.4, 5.10.2, 5.10.3, 5.27.1, 5.28, 5.29 9.2 Including

30、 reference to EN 610102-040:2005, Clause 7, ISO 14121:1999 and EN 615081:2010 5.2 9.3 5.7 10.1 5.2.1, 5.2.2, 8.2 c) and d) 11.1 Including reference to EN 610102-040:2005, Clause 12 and BS EN ISO 15883-1:2009+A1:2014 EN ISO 15883-1:2009+A1:2014 (E)6 EN 613261:2006 5.2.1, 5.2.2 11.4.1 Including refere

31、nce to EN 610102-040:2005, Clause 12 and EN 613261:2006 5.2.1, 5.2.4, 5.4, 5.7.4, 5.7.6, 5.8., 5.11, 5.12.7, 5.12.8, 5.12.9, 5.12.10, 5.13.2 g), 5.14 g), 5.17.2, 5.18, 5.20, 5.21 12.1 Including reference to EN 610102-040:2005, 4.4, 7.104, 14.103 and 14.104, and EN ISO 14971:2013 State of the art com

32、prehends many standards; note refers to EN ISO 12100:2003, ISO 13489-2:2003, and EN 9541:1997 5.2 12.5 Including reference to EN 613261:2006 5.2 12.6 Including reference to EN 610102-040:2005, 1.4, Clauses 4, 5 and 6, 11.6, Clause 14. Note refers to ISO 14121:1999 and EN 615081:2010 5.1, 5.2, 5.4, 5

33、.27.1 b) 12.7.1 Including reference to EN 610102-040:2005, 7.2, 7.3 and 7.4.101 5.2 12.7.2 Including reference to EN 610102-040:2005, Clause 8 5.2 12.7.3 Including reference to EN 610102-040:2005, 12.5.1 5.2 12.7.4 Including reference to EN 610102-040:2005, Clause 6 5.2, 5.8 12.7.5 Including referen

34、ce to EN 610102-040:2005, 10.1 5.10, 5.12 12.9 Including reference to IEC 60417:2004, ISO 7000:2012 and IEC 804161:2008 5.2, 5.4.1.3, 5.4.2, 5.23, 7, 8, 9.1 13.1 Including reference to EN 610102-040:2005, Clause 5 5.10.3 13.2 Including reference to IEC 60417:2004, ISO 7000:2012 and IEC 804161:2008 9

35、.1 b) and c) 13.3 k) 9.1 a) 13.3 I) 8.1 b) 13.4 8 k), 8 a), 8 j), 13.6 a) 5.2.3, 7, 8, 9.1 13.6 a), b), c), d) Including reference to EN 610102-040:2005, 5.1.2 8.1, 6.1.3 13.6 i) 8.3 j) 13.6 q) BS EN ISO 15883-1:2009+A1:2014 EN ISO 15883-1:2009+A1:2014 (E)7 WARNING Other requirements and other EU Di

36、rectives may be applicable to the product(s) falling within the scope of this standard. For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on Machinery, in accordance with Article 3 of Directive 93/42/EEC the following Table ZA.2 details the relevant esse

37、ntial requirements of Directive 2006/42/EC on Machinery to the extent to which they are more specific than those of Directive 93/42/EEC along with the corresponding clauses of this European Standard. Table ZA.2, however, does not imply any citation in the OJEU under the machinery directive and thus

38、does not provide presumption of conformity for the machinery directive. Table ZA.2 Relevant Essential Health and Safety Requirements from Directive 2006/42/EC on machinery that are addressed by this European Standard (according to article 3 of amended Directive 93/42/EEC) Clause(s)/sub-clause(s) of

39、this European Standard Essential Health and Safety Requirements (EHSRs) of Directive 2006/42/EC Qualifying remarks/Notes 5.2.3, 5.2.4 1 5.1.1, 5.2, 5.3.2.1 a) 1.1.3 9.2 1.1.5 5.12.3, 6.6.2 1.1.6 5.2 1.1.7 5.12.1 1.2.1 5.2, 5.18, 5.19 1.2.2 5.2 1.2.3 5.2, 5.18, 5.19 1.2.4 5.18, 5.19 1.2.5 5.2 1.2.6 5

40、.4.1.5, 5.18.4, 5.22, 6.3.5, 6.3.7 1.3.1 5.1, 5.2, 8.3 g) 1.3.2 5.2 1.3.3 5.2, 5.6 1.3.4 5.2 1.3.7 5.2 1.5.1 5.2, 6.3.1 1.5.2 5.2 1.5.3 5.2 1.5.4 5.2 1.5.5 5.2 1.5.6 5.2 1.5.8 5.2 1.5.13 5.2, 5.4.1.7 1.5.14 5.2, 8.3 g) 1.6.1 BS EN ISO 15883-1:2009+A1:2014 EN ISO 15883-1:2009+A1:2014 (E)8 5.1.5 1.6.2

41、 5.2 1.6.3 5.1.5 1.6.5 5.2, 5.10, 5.10.3, 5.12.3, 5.22, 8.3 a), 8.3 b) 1.7.1 5.2 1.7.2 5.2, 9.1 1.7.3 5.2, 8.3, 9.1 1.7.4 WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 15883-1:2009+A1:2014 EN ISO 15883-1:2

42、009+A1:2014 (E) ISO2006 Allrightsreserved iiiContents PageForeword. vIntroduction. vi1Scope . 12Normative references. 13Terms and definitions. 24Performance requirements 84.1 General. 84.2 Cleaning. 104.3 Disinfection . 104.4 Rinsing. 114.5 Drying. 114.6 Process chemicals 125Mechanical and processre

43、quirements . . 125.1 Materials, design and manufacture/construction 125.2 Safety. 145.3 Calorifiers and tanks 145.4 Loading and unloading doors and theircontrols 155.5 Pipework andfittings 175.6 Spray systems. 175.7 Dosing systems 185.8 Load temperature protection. 185.9 Process temperature control

44、limits 195.10 Switches, gauges and indicating devices 205.11 Process verification 205.12 Instrumentation and controls215.13 Temperature indicating systems. 225.14 Pressureindicating systems. 235.15 Timing equipment. 235.16 Operating cycle indicatingequipment235.17 Recording instruments (if fitted).2

45、35.18 Control systems 255.19 Override of automatic control .265.20 Microprocessor control systems 275.21 Access to software. 275.22 Fault indication systems 275.23 Water supply. 285.24 Venting and drainage systems 285.25 Drainage. 295.26 Airfilters installedwithin theWD 295.27 Load handling and supp

46、orts foruse within the WD . 295.28 Trolleys 305.29 Environment 316Testing for conformity 316.1 General. 316.2 Test equipment . 346.3 Tests on doors, interlocksand fault indications. 356.4 Tests on water quality andwater volume 376.5 Tests on pipework 396.6 Tests on instrumentationfitted to the WD.41

47、BS EN ISO 15883-1:2009+A1:2014 ISO 15883-1:2006+A1:2014 (E)iv ISO2006 Allrightsreserved6.7 Tests on load carriers.426.8 Thermometric tests.436.9 Chemicaldosing tests466.10 Tests of cleaning efficacy . .476.11 Tests of air quality486.12 Load drynesstest .496.13 Automatic control test497Documentation5

48、08Information to be supplied by the manufacturer.508.1 General.508.2 Before deliveryof the WD and for installation.518.3 At deliveryofthe WD519Marking, labellingand packaging .539.1 Marking and labelling .539.2 Packaging 5310 Information to be requested from the purchaserbythe supplier of the WD53An

49、nexA(informative) Test programme .55AnnexB(informative) A 0 concept Comparative lethalityofmoist heat processes59AnnexC(normative) Test methodsfor the detection and assessment of residual proteinaceouscontamination63AnnexD(normative) Microbiological recovery mediumfor estimationof bacterial contaminationof water.68Bibliography.69BS EN ISO 15883-1:2009+A1:2014 ISO 15883-1:2006+A1:2014 (E) ISO2006 Allrightsreserved vForeword ISO (the International Organization forStandardization)isa worldwide fed