1、BS EN ISO15883-2:2009ICS 11.080.10NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDWasher-disinfectorsPart 2: Requirements and tests forwasher-disinfectors employing thermaldisinfection for surgical instruments,anaesthetic equipment, bowls, dishes,receivers, uten
2、sils, glassware, etc. (ISO15883-2:2006)This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2009 BSI 2009ISBN 978 0 580 66664 3Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 15883-2:2009National forewordThis Britis
3、h Standard is the UK implementation of EN ISO 15883-2:2009. It is identical to ISO 15883-2:2006. It supersedes BS EN ISO 15883-2:2006 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee LBI/35, Sterilizers, autoclaves and disinfectors.A list of organizatio
4、ns represented on this 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.EUR
5、OPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 15883-2June 2009ICS 11.080.10 Supersedes EN ISO 15883-2:2006 English VersionWasher-disinfectors - Part 2: Requirements and tests forwasher-disinfectors employing thermal disinfection for surgicalinstruments, anaesthetic equipment, bowls, dishes, rec
6、eivers,utensils, glassware, etc. (ISO 15883-2:2006)Laveurs dsinfecteurs - Partie 2: Exigences et essais pourlaveurs dsinfecteurs destins la dsinfection thermiquedes instruments chirurgicaux, du matriel danesthsie, desbacs, plats, rcipients, ustensiles, de la verrerie, etc. (ISO15883-2:2006)Reinigung
7、s-Desinfektionsgerte - Teil 2: Anforderungenund Prfverfahren von Reinigungs-Desinfektionsgertenmit thermischer Desinfektion fr chirurgische Instrumente,Ansthesiegerte, Gefe, Utensilien, Glasgerte usw.(ISO 15883-2:2006)This European Standard was approved by CEN on 16 May 2009.CEN members are bound to
8、 comply 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 Mana
9、gement 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 th
10、eofficial 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,
11、Slovenia, 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 na
12、tional Members.Ref. No. EN ISO 15883-2:2009: EBS EN ISO 15883-2:2009EN ISO 15883-2:2009 (E) 3 Foreword The text of ISO 15883-2:2006 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” of the International Organization for Standardization (ISO) and has been tak
13、en over as EN ISO 15883-2:2009 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 standard, either by publication of an identical text or by endorsement, at the latest by Decembe
14、r 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 rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rig
15、hts. This document supersedes EN ISO 15883-2:2006. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directive. For relationship with EC Directive, see informative Annex ZA, which
16、 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Gre
17、ece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 15883-2:2006 has been approved by CEN as a EN ISO 15883-2:2009 withou
18、t any modification. BS EN ISO 15883-2:2009EN ISO 15883-2:2009 (E) 4 Annex ZA (informative) Relationship between 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 Eur
19、opean Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach 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
20、at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within 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
21、 between this European Standard and Directive 93/42/EEC on medical devices Clauses/subclauses of this International Standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 4.1.1 1, 2, 3, 4, 5, 6, 7.1, 7.2, 7.3, 7.5, 7.6, 8.1, 9.1, 9.2, 9.3, 12.1, 12.5, 12.6, 12.7.1,
22、12.7.2, 12.7.3, 12.7.5, 13.1, 13.3, 13.4 The WD shall comply with the requirements of ISO 15883-1: 4.1.2 1, 3, 4, 6, 7.1, 8.1, 9.1 4.1.3 1, 3, 4, 6, 7.1, 8.1, 9.1 4.1.5 3, 7.1 4.1.6 7.3, 8.1 4.2 3, 8.1 4.3 3, 8.1 4.4 3, 8.1 5.1 3, 8.1 5.2 3, 8.1 5.3 3, 8.1 6.1 1, 2, 3, 4, 7.1, 8.1 Testing for confor
23、mity according to ISO 15883-1: 6.2 3, 8.1 6.3 3, 8.1 7 9.1, 13.6 8 1, 3, 7.1, 7.2, 8.1 BS EN ISO 15883-2:2009EN ISO 15883-2:2009 (E) 5 7.4, 8.2, 8.3, 8.4, 8.5, 8.6, 8.7, 10.1, 10.2, 10.3, Clause 11, 12.2, 12.3, 12.4, 12.7.4, 12.8, 13.5, 14 not applicable - 12.1a) This relevant Essential Requirement
24、is not addressed in this European Standard 4.1.1 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 applicable to
25、 the product(s) falling within the scope of this standard. BS EN ISO 15883-2:2009EN ISO 15883-2:2009 (E) 6 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 detail
26、s 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 clauses of this European Standard. Table ZA.2, however, does not imply any citation in the OJEU under the machinery
27、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 machinery that are addressed by this European Standard (according to article 3 of amended Directive 93/42/EEC) Clause(s
28、)/sub-clause(s) of this EN Essential Health and SafetyRequirements (EHSRs) ofDirective 2006/42/EC Qualifying remarks/Notes 4.1.1 1.1.7, 1.2.2, 1.2.3, 1.2.4, 1.2.5, 1.3.2, 1.3.3, 1.3.4, 1.5.1, 1.5.2, 1.5.3, 1.5.5, 1.5.6, 1.5.8, 1.5.13, 1.5.14, 1.6.2, 1.6.3, 1.6.4, 1.6.5 This relevant EHSR are address
29、ed in this Standard 4.1.1 1.1.3, 1.1.5, 1.1.6, 1.2.1, 1.2.6, 1.3.1, 1.3.7, 1.3.8.1, 1.3.8.2, 1.5.4, 1.6.1, 1.7.1, 1.7.2, ,1.7.3, 1.7.4 This relevant EHSR are partly addressed in this Standard 1.3.9, 1.4.1, 1.4.2, 1.4.3, 1.5.9, 4 This relevant EHSR are not addressed in this Standard BS EN ISO 15883-2
30、:2009ISO 15883-2:2006(E) ISO 2006 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 2 4 Performance requirements 2 4.1 General. 2 4.2 Cleaning. 3 4.3 Disinfecting . 3 4.4 Temperature of internal surfaces of processed devic
31、es 4 5 Mechanical and control requirements 4 5.1 Load connectors . 4 5.2 Control systems 5 5.3 Process verification 5 6 Testing for conformity 5 6.1 General. 5 6.2 Tests for soil removal from chamber walls, load carrier and load 5 6.3 Thermometric tests. 6 7 Information to be supplied by the manufac
32、turer. 8 8 Information to be requested from the purchaser by the supplier of the WD 8 Annex A (informative) Summary of test programmes 9 Bibliography . 10 BS EN ISO 15883-2:2009ISO 15883-2:2006(E) iv ISO 2006 All rights reservedForeword ISO (the International Organization for Standardization) is a w
33、orldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented
34、on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafte
35、d in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Stand
36、ard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 15883-2 was prepared
37、by the European Committee for Standardization (CEN) Technical Committee CEN/TC 102, Sterilizers for medical purposes, in collaboration with Technical Committee ISO/TC 198, Sterilization of health care products, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agr
38、eement). ISO 15883 consists of the following parts, under the general title Washer-disinfectors: Part 1: General requirements, terms and definitions and tests Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls,
39、 dishes, receivers, utensils, glassware, etc. Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes Part 5: Test soils and met
40、hods for demonstrating cleaning efficacy Technical specification BS EN ISO 15883-2:2009ISO 15883-2:2006(E) ISO 2006 All rights reserved vIntroduction It is recommended that this Introduction be read in conjunction with the introduction to ISO 15883-1:2006. This part of ISO 15883 is the second of a s
41、eries of standards specifying the performance of washer-disinfectors and specifies the general requirements for performance applicable to instrument washer-disinfectors. The requirements given in this part apply to washer-disinfectors used for cleaning and thermal disinfection of medical devices int
42、ended for re-use such as: surgical instruments; powered devices; instrument trays; instruments for minimally invasive surgery; lumen devices and tubing; rigid endoscopes; anaesthetic and respiratory equipment; bowls, dishes and receivers; glassware; containers for transit. Fields of application with
43、in the scope of the ISO 15883 series of standards include laboratory, veterinary, dental and pharmaceutical applications and other specific applications, such as washer-disinfectors for bedsteads and transport carts and the disinfection of crockery and cutlery intended for use with immunologically c
44、ompromised patients. Requirements for washer-disinfectors for other applications are specified in other parts of the ISO 15883 series of standards. When processed in the instrument washer-disinfector, the medical devices might be intended for immediate use or might be intended for packing and steril
45、ization. In both cases, the efficacy of the cleaning and disinfection is of major importance. In either case, this is for the well being of the patient. In the latter case, it is also for the safety of the staff who handles the instruments in the process of inspection, testing and packing as well as
46、 ensuring that the sterilization process is not unduly challenged by residual soil. The efficacy of disinfection can be impaired if soil removal is incomplete before the start of the disinfection process. Users should be aware that some medical devices might require pre-treatment e.g. soaking, brush
47、ing, ultra sonic pre-cleaning, lumen irrigation or any combination of these techniques. Reference should be made to the medical manufacturers instructions for reprocessing (see also ISO 17664). Safety requirements for washer-disinfectors are given in IEC 61010-2-045. BS EN ISO 15883-2:2009ISO 15883-
48、2:2006(E) vi ISO 2006 All rights reservedIn respect of the potential adverse effects on the quality of water intended for human consumption caused by the washer-disinfectors: a) it should be noted that, until verifiable European criteria are adopted, existing national regulations concerning the use
49、and/or the characteristics of the washer-disinfectors remain in force; b) the ISO 15883 series of standards provides no information as to whether the washer-disinfectors may be used without restriction in any of the member states of the EU or EFTA. BS EN ISO 15883-2:2009INTERNATIONAL STANDARD ISO 15883-2:2006(E) ISO 2006 All rights reserved 1Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, di
