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)Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 17/12/2009 06:29, Uncontroll
2、ed Copy, (c) BSIThis British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2009 BSI 2009ISBN 978 0 580 66657 5Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 15883-1:2009National forewordThis British Standard is the UK im
3、plementation of EN ISO 15883-1:2009. It is identical to ISO 15883-1:2006. It supersedes BS EN ISO 15883-1:2006 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee LBI/35, Sterilizers, autoclaves and disinfectors.A list of organizations represented on this
4、committee can be obtained on request to its secretary.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.Licensed Copy: Wang Bin, I
5、SO/EXCHANGE CHINA STANDARDS, 17/12/2009 06:29, Uncontrolled Copy, (c) BSIEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 15883-1June 2009ICS 11.080.10 Supersedes EN ISO 15883-1:2006 English VersionWasher-disinfectors - Part 1: General requirements, terms anddefinitions and tests (ISO 15883-1:2
6、006)Laveurs dsinfecteurs - Partie 1: Exigences gnrales,termes et dfinitions et essais (ISO 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 comp
7、ly with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this 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 Managemen
8、t 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theoffi
9、cial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slove
10、nia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN nationa
11、l Members.Ref. No. EN ISO 15883-1:2009: ELicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 17/12/2009 06:29, Uncontrolled Copy, (c) BSIBS EN ISO 15883-1:2009EN ISO 15883-1:2009 (E) 3 Foreword The text of ISO 15883-1:2006 has been prepared by Technical Committee ISO/TC 198 “Sterilization of heal
12、th care products” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 15883-1:2009 by Technical Committee 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 st
13、andard, either by publication of an identical text or by endorsement, at the latest by December 2009, and conflicting national standards shall be withdrawn at the latest by March 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent right
14、s. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 15883-1:2006. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential req
15、uirements of EC Directive. For relationship with EC Directive, 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: Austr
16、ia, Belgium, Bulgaria, 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 the United Kingdom. Endorsemen
17、t notice The text of ISO 15883-1:2006 has been approved by CEN as a EN ISO 15883-1:2009 without any modification. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 17/12/2009 06:29, Uncontrolled Copy, (c) BSIBS EN ISO 15883-1:2009EN ISO 15883-1:2009 (E) 4 Annex ZA (informative) Relationship bet
18、ween this European Standard and the Essential Requirements of EU Directive 93/42/EEC 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
19、 Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Communities 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
20、 the limits of the scope 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 thisEurope
21、an Standard Essential requirements (ERs)of EU Directive 93/42/EEC Qualifying remarks/Notes 4 1, 4, 3, 6, 7.1, 8.1, 9.1, 7.2, 9.2 5.1 2, 7.3 5.1.3 4 5.1.7 7.5 5.1.8 7.5 5.2 1, 2, 6, 7.1, 7.2, 7.3, 7.5, 8.1, 9.1, 9.2, 9.3, 12.5, 12.6, 12.7.1, 12.7.2, 12.7.3, 12.7.4, 12.7.5, 13.1 The WD shall comply wi
22、th the requirements of IEC 61010-2-045 5.4 7.5 Refers only to leakage 5.4.1.2 7.2, 7.5 5.4.1.3 13.1 5.4.1.5 1, 2 5.4.1.6 1, 2 5.4.1.7 1, 2 5.4.1.8 1, 2 5.4.2 13.1 5.4.3 8.1 5.4.4 8.1 5.4.5.2 2 5.4.5.3 2, 7.5 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 17/12/2009 06:29, Uncontrolled Copy,
23、(c) BSIBS EN ISO 15883-1:2009EN ISO 15883-1:2009 (E) 5 Table ZA.1 (continued) Clauses/subclauses of thisEuropean Standard Essential requirements (ERs)of EU Directive 93/42/EEC Qualifying remarks/Notes 5.5.1 2, 7.2 5.5.2 2 5.7 3, 7.2, 7.3 5.8 2, 12.1, 12.7.5 5.9 3 5.10. 13.2 5.11.1 3 5.11.2 2, 3 5.11
24、.3 2, 3 The choice of process verification system shall be based on a documented risk analysis 5.11.4 2, 3 5.12 3, 12.9 5.13 3 5.14 3 5.15 3 5.16 3 5.17 3 5.18 3 5.19 3 5.20 12.1 5.21 12.1 5.22 2, 3 5.23 3, 13.1 5.24 7.2, 7.5 5.25 7.2, 7.5 5.27 3 5.28 3 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA ST
25、ANDARDS, 17/12/2009 06:29, Uncontrolled Copy, (c) BSIBS EN ISO 15883-1:2009EN ISO 15883-1:2009 (E) 6 Table ZA.1 (continued) Clauses/subclauses of thisEuropean Standard Essential requirements (ERs)of EU Directive 93/42/EEC Qualifying remarks/Notes 5.29 3 6.1 1, 2, 3, 6, 7.1, 8.1 Testing for conformit
26、y 6.2 1, 2, 3, 6, 7.1, 8.1 Testing for conformity 6.3.5 2, 3 6.3.6 2, 3 6.3.7 2, 3 6.4 3 6.5.3 7.5 6.5.4 3 6.5.5 3 6.5.6 3 6.6 3 6.7 3 6.8 3 6.9 3, 7.3 6.10 3, 7.2, 7.5 6.11 3, 7.2, 7.5 6.12 3, 7.2, 7.5 6.13 3, 7.2, 7.5 7 13 8 13.1, 13.3, 13.4, 13.6 9 5, 13.3 10 1 - 12.1a) This relevant Essential Re
27、quirement is not addressed in this European Standard 7, 8, 9 13.3 a) This relevant Essential Requirement is partly addressed in this European Standard - 13.6 q) This relevant Essential Requirement is not addressed in this European Standard WARNING: Other requirements and other EU Directives may be a
28、pplicable to the product(s) falling within the scope of this standard. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 17/12/2009 06:29, Uncontrolled Copy, (c) BSIBS EN ISO 15883-1:2009EN ISO 15883-1:2009 (E) 7 For devices which are also machinery within the meaning of Article 2(a) of Directi
29、ve 2006/42/EC on Machinery, in accordance with Article 3 of Directive 93/42/EEC the following table ZA.2 details the relevant essential 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 claus
30、es of this European Standard. Table ZA.2, however, does not imply any citation in the OJEU under the machinery directive and thus 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 machiner
31、y that are addressed by this European Standard (according to article 3 of amended Directive 93/42/EEC) Clause(s)/sub-clause(s) of this EN Essential Health and SafetyRequirements (EHSRs) ofDirective 2006/42/EC Qualifying remarks/Notes5.1.1, 5.2, 5.3.2.1 a) 1.1.3 This relevant EHSR is partly addressed
32、 in this Standard 9.2 1.1.5 This relevant EHSR is partly addressed in this Standard 5.12.3, 6.6.2 1.1.6 This relevant EHSR is partly addressed in this Standard 5.2 1.1.7 This relevant EHSR is addressed in this Standard 5.12.1 1.2.1 This relevant EHSR is partly addressed in this Standard 5.2, 5.18, 5
33、.19 1.2.2 This relevant EHSR is addressed in this Standard 5.2 1.2.3 This relevant EHSR is addressed in this Standard 5.2, 5.18.5.19 1.2.4 This relevant EHSR is addressed in this Standard 5.18, 5.19 1.2.5 This relevant EHSR is addressed in this Standard 5.2 1.2.6 This relevant EHSR is partly address
34、ed in this Standard 5.4.1.5, 5.18.4, 5.22, 6.3.5, 6.3.7 1.3.1 This relevant EHSR is partly addressed in this Standard 5.1, 5.2, 8.3 g) 1.3.2 This relevant EHSR is addressed in this Standard 5.2 1.3.3 This relevant EHSR is addressed in this Standard 5.2, 5.6 1.3.4 This relevant EHSR is addressed in t
35、his Standard 5.2 1.3.7 This relevant EHSR is partly addressed in this Standard 5.2 1.3.8.1 This relevant EHSR is partly addressed in this Standard 5.2 1.3.8.2 This relevant EHSR is partly addressed in this Standard 1.3.9 This relevant EHSR is not addressed in this Standard 1.4.1 This relevant EHSR i
36、s not addressed in this Standard 1.4.2 This relevant EHSR is not addressed in this Standard Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 17/12/2009 06:29, Uncontrolled Copy, (c) BSIBS EN ISO 15883-1:2009EN ISO 15883-1:2009 (E) 8 Table ZA.2 (continued) Clause(s)/sub-clause(s) of this EN Ess
37、ential Health and SafetyRequirements (EHSRs) ofDirective 2006/42/EC Qualifying remarks/Notes 1.4.3 This relevant EHSR is not addressed in this Standard 5.2 1.5.1 This relevant EHSR is addressed in this Standard 5.2, 6.3.1 1.5.2 This relevant EHSR is addressed in this Standard 5.2 1.5.3 This relevant
38、 EHSR is addressed in this Standard 5.2 1.5.4 This relevant EHSR is partly addressed in this Standard 5.2 1.5.5 This relevant EHSR is addressed in this Standard 5.2 1.5.6 This relevant EHSR is addressed in this Standard 5.2 1.5.8 This relevant EHSR is addressed in this Standard 1.5.9 This relevant E
39、HSR is not addressed in this Standard 5.2 1.5.13 This relevant EHSR is addressed in this Standard 5.2, 5.4.1.7 1.5.14 This relevant EHSR is addressed in this Standard 5.2, 8.3 g) 1.6.1 This relevant EHSR is partly addressed in this Standard 5.1.5 1.6.2 This relevant EHSR is addressed in this Standar
40、d 5.2 1.6.3 This relevant EHSR is addressed in this Standard 5.1.5 1.6.4 This relevant EHSR is addressed in this Standard 5.1.5 1.6.5 This relevant EHSR is addressed in this Standard 5.2, 5.10, 5.10.3, 5.12.3, 5.22, 8.3 a), 8.3 b) 1.7.1 This relevant EHSR is partly addressed in this Standard 5.2 1.7
41、.2 This relevant EHSR is partly addressed in this Standard 5.2, 9.1 1.7.3 This relevant EHSR is partly addressed in this Standard 5.2, 8.3, 9.1 1.7.4 This relevant EHSR is partly addressed in this Standard 4 This relevant EHSR is not addressed in this standard Licensed Copy: Wang Bin, ISO/EXCHANGE C
42、HINA STANDARDS, 17/12/2009 06:29, Uncontrolled Copy, (c) BSIBS EN ISO 15883-1:2009ISO 15883-1:2006(E) ISO 2006 All rights reserved iiiContents Page Foreword. v Introduction . vi 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 2 4 Performance requirements 8 4.1 General. 8 4.2 Cleaning
43、. 10 4.3 Disinfection . 10 4.4 Rinsing. 11 4.5 Drying. 11 4.6 Process chemicals 12 5 Mechanical and process requirements 12 5.1 Materials, design and manufacture/construction 12 5.2 Safety . 14 5.3 Calorifiers and tanks 14 5.4 Loading and unloading doors and their controls 15 5.5 Pipework and fittin
44、gs 17 5.6 Spray systems. 17 5.7 Dosing systems 18 5.8 Load temperature protection. 18 5.9 Process temperature control limits 19 5.10 Switches, gauges and indicating devices 20 5.11 Process verification 20 5.12 Instrumentation and controls 21 5.13 Temperature indicating systems. 22 5.14 Pressure indi
45、cating systems . 23 5.15 Timing equipment. 23 5.16 Operating cycle indicating equipment 23 5.17 Recording instruments (if fitted). 23 5.18 Control systems 25 5.19 Override of automatic control . 26 5.20 Microprocessor control systems 27 5.21 Access to software . 27 5.22 Fault indication systems 27 5
46、.23 Water supply . 28 5.24 Venting and drainage systems 28 5.25 Drainage. 29 5.26 Air filters installed within the WD 29 5.27 Load handling and supports for use within the WD . 29 5.28 Trolleys 30 5.29 Environment 31 6 Testing for conformity 31 6.1 General. 31 6.2 Test equipment . 34 6.3 Tests on do
47、ors, interlocks and fault indications. 35 6.4 Tests on water quality and water volume 37 6.5 Tests on pipework 39 6.6 Tests on instrumentation fitted to the WD . 41 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 17/12/2009 06:29, Uncontrolled Copy, (c) BSIBS EN ISO 15883-1:2009ISO 15883-1:20
48、06(E) iv ISO 2006 All rights reserved6.7 Tests on load carriers. 42 6.8 Thermometric tests. 43 6.9 Chemical dosing tests 46 6.10 Tests of cleaning efficacy 47 6.11 Tests of air quality 48 6.12 Load dryness test . 49 6.13 Automatic control test 49 7 Documentation 50 8 Information to be supplied by th
49、e manufacturer . 50 8.1 General . 50 8.2 Before delivery of the WD and for installation. 51 8.3 At delivery of the WD 51 9 Marking, labelling and packaging . 53 9.1 Marking and labelling . 53 9.2 Packaging 53 10 Information to be requested from the purchaser by the supplier of the WD 53 Annex A (informative) Test programme . 55 Annex B (informative) A0concept Comparative lethality of moist heat processes 59 Annex C (normative) Test methods for the detection and assessment of residual proteinaceous contamination 63 Annex D (normative) Microbiological recovery me
