EN ISO 15883-3-2009 en Washer-disinfectors - Part 3 Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers《洗涤器消毒器 第3部分 对人类废弃物容器进行热.pdf
《EN ISO 15883-3-2009 en Washer-disinfectors - Part 3 Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers《洗涤器消毒器 第3部分 对人类废弃物容器进行热.pdf》由会员分享,可在线阅读,更多相关《EN ISO 15883-3-2009 en Washer-disinfectors - Part 3 Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers《洗涤器消毒器 第3部分 对人类废弃物容器进行热.pdf(24页珍藏版)》请在麦多课文档分享上搜索。
1、BS EN ISO15883-3:2009ICS 11.080.10NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDWasher-disinfectorsPart 3: Requirements and testsfor washer-disinfectors employingthermal disinfection for human wastecontainers (ISO 15883-3:2006)This British Standard was publish
2、ed under the authority of the Standards Policy and Strategy Committee on 31 October 2009 BSI 2009ISBN 978 0 580 66660 5Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 15883-3:2009National forewordThis British Standard is the UK implementation of EN ISO 15883-3:2009. It is identi
3、cal to ISO 15883-3:2006. It supersedes BS EN ISO 15883-3:2006 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee LBI/35, Sterilizers, autoclaves and disinfectors.A list of organizations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 committee can be obtained on request to its secre
4、tary.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.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 15883-3June 2009ICS 1
5、1.080.10 Supersedes EN ISO 15883-3:2006 English VersionWasher-disinfectors - Part 3: Requirements and tests forwasher-disinfectors employing thermal disinfection for humanwaste containers (ISO 15883-3:2006)Laveurs dsinfecteurs - Partie 3: Exigences et essais pourlaveurs dsinfecteurs destins la dsinf
6、ection thermiquede rcipients djections humaines (ISO 15883-3:2006)Reinigungs-Desinfektionsgerte - Teil 3: Anforderungen anund Prfverfahren fr Reinigungs-Desinfektionsgerten mitthermischer Desinfektion fr Behlter fr menschlicheAusscheidungen (ISO 15883-3:2006)This European Standard was approved by CE
7、N on 16 May 2009.CEN members are bound to 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 b
8、e obtained on application to the CEN Management 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 Ma
9、nagement Centre has the same status as theofficial 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, Nor
10、way, Poland, Portugal,Romania, Slovakia, 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
11、by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 15883-3:2009: EBS EN ISO 15883-3:2009EN ISO 15883-3:2009 (E) 3 Foreword The text of ISO 15883-3:2006 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” of the International Organization f
12、or Standardization (ISO) and has been taken over as EN ISO 15883-3:2009 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
13、 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 rights. CEN and/or CENELEC shall not be held responsible f
14、or identifying any or all such patent rights. This document supersedes EN ISO 15883-3:2006. 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 D
15、irective, 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, Cyprus, Czech Republic, Denmar
16、k, 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. Endorsement notice The text of ISO 15883-3:2006 has been approv
17、ed by CEN as a EN ISO 15883-3:2009 without any modification. BS EN ISO 15883-3:2009EN ISO 15883-3:2009 (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 C
18、EN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Communities under that Directive and has be
19、en 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 scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EF
20、TA regulations. Table ZA.1 Correspondence 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, 2, 3,4, 5, 6, 7.1, 7.2, 7.3, 7.5, 7.6, 8.1, 9.1
21、, 9.2, 9.3, 12.1, 12.5, 12.6, 12.7.1, 12.7.2, 12.7.3, 12.7.5, 13.1, 13.3, 13.4, 13.6 The WD shall comply with the requirements of ISO 15883-1: 4.2 7.3, 8.1 4.3 2, 7.2, 7.5, 8.1, 9.1 4.4 3, 8.1 4.5 3, 8.1 4.6 3, 8.1 4.7 3, 8.1 5.1 3, 8.1 5.2 3, 8.1 5.3 7.2, 7.5, 8.1 6.1 1, 2, 3, 6, 7.1, 8.1 Testing f
22、or conformity according to ISO 15883-1: 6.2 7.2, 7.5, 8.1, 91 BS EN ISO 15883-3:2009EN ISO 15883-3:2009 (E) 5 Table ZA.1 (continued) Clauses/subclauses of this European Standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 6.3 3, 8.1 6.4 3, 8.1 6.5.1, 6.5.2 2, 3, 7
23、.2, 7.5, 8.1, 9.1 6.6 3, 8.1 7 9.1, 13.1, 13.3, 13.6 7 a) 9.1 7 g) 3, 8.1 8 1.3, 7.1, 7.2, 7.3, 8.1 8 c) 7.3 8 e) 3, 8.1 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 is not address
24、ed 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 the product(s
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