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

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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 It supersedes BS EN ISO 15883-3:2006 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee LBI/35, Sterilizers, autoclaves and disinfectors.A list of organizations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

25、) falling within the scope of this standard. BS EN ISO 15883-3:2009EN ISO 15883-3:2009 (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 details the relevant

26、 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 directive and

27、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)/sub-clause(s

28、) 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 addressed in this Sta

29、ndard 4.1.1, 4.3 1.1.3 This relevant EHSR is partly addressed in this Standard 4.1.1 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

30、are not addressed in this Standard BS EN ISO 15883-3:2009ISO 15883-3:2006(E) ISO 2006 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 1 4 Performance requirements 2 4.1 General. 2 4.2 Chemical dosing systems 2 4.3 Emptyi

31、ng 3 4.4 Cleaning. 3 4.4.1 Flushing . 3 4.4.2 Washing . 3 4.4.3 Test requirements. 3 4.5 Disinfecting . 3 4.6 Rinsing. 4 4.7 Drying. 4 5 Mechanical and control requirements 4 5.1 Instrumentation and control 4 5.2 Process 4 5.3 Venting, draining and purging. 4 5.4 Water quality . 5 6 Testing for conf

32、ormity 5 6.1 General. 5 6.2 Test for drain seal integrity 5 6.3 Test for flushing of non-absorbent materials 5 6.4 Test for flushing of absorbent material (toilet tissue) 5 6.5 Test for loading/emptying of containers 5 6.5.1 Automatic emptying . 5 6.5.2 Manual emptying. 6 6.6 Tests for soil removal

33、from chamber walls, load carrier and load 6 7 Information to be supplied by the manufacturer. 6 8 Information to be requested from the purchaser by the supplier of the WD 7 Annex A (informative) Summary of test programmes 8 Annex B (normative) Specification for toilet tissue for use in tests on wash

34、er-disinfectors for human-waste containers 9 Annex C (informative) Measurement of water absorbency of toilet tissue by the basket method 10 Bibliography . 11 BS EN ISO 15883-3:2009ISO 15883-3:2006(E) iv ISO 2006 All rights reservedForeword ISO (the International Organization for Standardization) is

35、a worldwide 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 represent

36、ed 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 dra

37、fted 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 St

38、andard 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 15883-3 was prepar

39、ed 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

40、Agreement). 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, bow

41、ls, 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

42、methods for demonstrating cleaning efficacy Technical Specification BS EN ISO 15883-3:2009ISO 15883-3:2006(E) ISO 2006 All rights reserved vIntroduction It is recommended that this Introduction be read in conjunction with the introduction to ISO 15883-1. This part of ISO 15883 is the third of a seri

43、es of standards specifying the performance of washer-disinfectors and specifies the general requirements for performance applicable to bedpan washer-disinfectors. The requirements given in this part apply to washer-disinfectors used for emptying, flushing, cleaning and thermally disinfecting human w

44、aste containers intended for re-use such as: portable sanitary pans; supports for single-use bed pans; hospital bowls; urine bottles; suction bottles; and products similar to the above and used for similar purposes. Fields of application within the scope of the ISO 15883 series of standards include

45、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 compromised patients. Requirements for washer-disinfectors

46、for other applications are specified in other parts the ISO 15883 series of standards. Bedpan washer disinfectors are loaded manually. In order to reduce the risk of spillage and the generation of aerosols most machines incorporate means to empty human waste containers automatically e.g. by the acti

47、on of closing the door. Where equipment does not provide automatic emptying facilities, extra care is needed by the user to avoid exposure to human waste and contamination of the work environment including the generation of aerosols. The reliability of a bedpan washer-disinfector may be adversely af

48、fected if the machine is connected to a poorly designed or constructed drainage system. The purchaser is therefore recommended to ensure that the drainage system complies with the manufacturers recommendations in all respects. Safety requirements for washer-disinfectors are given in IEC 61010-2-045.

49、 In respect of the potential adverse effects on the quality of water intended for human consumption caused by the washer-disinfectors: a) note that until verifiable European criteria are adopted, existing national regulations concerning the use and/or the characteristics of the washer-disinfectors remain in force; b) this part of ISO 15883 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 15883-3:2009BS EN ISO 15883-3:2009