DIN EN ISO 15883-3-2009 Washer-disinfectors - Part 3 Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3 2006) Eng.pdf

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1、September 2009DEUTSCHE NORM English price group 12No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.080.10!$Ybl“15463

2、73www.din.deDDIN EN ISO 15883-3Washer-disinfectors Part 3: Requirements and tests for washer-disinfectors employingthermal disinfection for human waste containers (ISO 15883-3:2006)English version of DIN EN ISO 15883-3:2009-09Reinigungs-Desinfektionsgerte Teil 3: Anforderungen an und Prfverfahren fr

3、 Reinigungs-Desinfektionsgerte mitthermischer Desinfektion fr Behlter fr menschliche Ausscheidungen(ISO 15883-3:2006)Englische Fassung DIN EN ISO 15883-3:2009-09SupersedesDIN EN ISO 15883-3:2006-07See start of validitywww.beuth.deDocument comprises 22 pagesDIN EN ISO 15883-3:2009-09 2 Start of valid

4、ity This standard takes effect on 1 September 2009. DIN EN ISO 15883-3:2006-07 may be used in parallel until 21 March 2010. National foreword This standard has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” in collaboration with Technical Committee CEN/TC 102

5、 “Sterilizers for medical purposes” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Technical Committee NA 063-04-09 AA Reinigungs-Desinfektionsgerte. This standard contains specifications meeting the

6、 essential requirements set out in EU Directive 93/42/EEC on medical devices. DIN EN 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 t

7、hermal disinfection for surgical instruments, anaesthetic equipment, bowls, 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 c

8、hemical disinfection for thermolabile endoscopes Part 5: Test soils and methods for demonstrating cleaning efficacy Technical Specification Part 6: Requirements and tests for general purpose washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthc

9、are equipment (at present at the stage of draft) The DIN Standards corresponding to the International Standards referred to in this document are as follows: IEC 61010-2-045 DIN EN 61010-2-0451)Amendments This standard differs from DIN EN ISO 15883-3:2006-07 as follows: a) Annex ZA (informative) conc

10、erning the relationship between this European Standard and the essential requirements of EU Directive 93/42/EEC on medical devices has been updated on the basis of EU Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directives 90/385/EEC on the

11、approximation of the laws of the Member States relating to active implantable medical devices and 93/42/EEC on medical devices and EU Directive 98/8/EC on the placing on the market of biocidal products. 1)Withdrawn; replaced by: DIN EN 61010-2-040. DIN EN ISO 15883-3:2009-09 3 Previous editions DIN

12、EN ISO 15883-3: 2006-07 National Annex NA (informative) Bibliography DIN EN 61010-2-040, Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials DIN EN ISO 158

13、83-3:2009-09 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15883-3 June 2009 ICS 11.080.10 Supersedes EN ISO 15883-3:2006 English Version Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for huma

14、n waste containers (ISO 15883-3:2006) Laveurs dsinfecteurs - Partie 3: Exigences et essais pour laveurs dsinfecteurs destins la dsinfection thermique de rcipients djections humaines (ISO 15883-3:2006) Reinigungs-Desinfektionsgerte - Teil 3: Anforderungen an und Prfverfahren fr Reinigungs-Desinfektio

15、nsgerte mit thermischer Desinfektion fr Behlter fr menschliche Ausscheidungen (ISO 15883-3:2006) 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 this European Standard the s

16、tatus of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German)

17、. A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Repu

18、blic, 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 FOR STANDARDIZATION COMIT EUROPEN DE

19、 NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 15883-3:2009: EContents 2 DIN EN ISO 15883-3:2009-09 EN ISO 15883-3:2009 (E

20、) Page Foreword .3 Introduction.4 1 Scope5 2 Normative references5 3 Terms and definitions .5 4 Performance requirements.6 4.1 General .6 4.2 Chemical dosing systems 6 4.3 Emptying 7 4.4 Cleaning .7 4.5 Disinfecting 7 4.6 Rinsing8 4.7 Drying .8 5 Mechanical and control requirements.8 5.1 Instrumenta

21、tion and control.8 5.2 Process.8 5.3 Venting, draining and purging .8 5.4 Water quality 9 6 Testing for conformity 9 6.1 General .9 6.2 Test for drain seal integrity 9 6.3 Test for flushing of non-absorbent materials.9 6.4 Test for flushing of absorbent material (toilet tissue).9 6.5 Test for loadin

22、g/emptying of containers.9 6.6 Tests for soil removal from chamber walls, load carrier and load.10 7 Information to be supplied by the manufacturer .10 8 Information to be requested from the purchaser by the supplier of the WD 11 Annex A (informative) Summary of test programmes.12 Annex B (normative

23、) Specification for toilet tissue for use in tests on washer-disinfectors for human-waste containers 13 Annex C (informative) Measurement of water absorbency of toilet tissue by the basket method.14 Bibliography15 Annex ZA (informative) Relationship between this European Standard and the Essential R

24、equirements of EU Directive 93/42/EEC .16 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 for Standardization (ISO) and has been taken over as EN ISO 15883-3:2009 by Technical Committe

25、e 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 December 2009, and conflicting national standards shall be

26、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 rights. This document supersedes EN ISO 15883-3:2006. T

27、his 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 is an integral part of this document. According to

28、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, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithu

29、ania, 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 approved by CEN as a EN ISO 15883-3:2009 without any modification. 3 DIN EN ISO 15883-3:2009-09 EN

30、ISO 15883-3:2009 (E) Introduction 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 series of standards specifying the performance of washer-disinfectors and specifies the general requirements for performanc

31、e applicable to bedpan washer-disinfectors. The requirements given in this part apply to washer-disinfectors used for emptying, flushing, cleaning and thermally disinfecting human waste containers intended for re-use such as: portable sanitary pans; supports for single-use bed pans; hospital bowls;

32、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 laboratory, veterinary, dental and pharmaceutical applications and other specific applications, such as washer-disinfec

33、tors for bedsteads and transport carts and the disinfection of crockery and cutlery intended for use with immunologically compromised patients. Requirements for washer-disinfectors for other applications are specified in other parts the ISO 15883 series of standards. Bedpan washer disinfectors are l

34、oaded 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 action of closing the door. Where equipment does not provide automatic emptying facilities, extra care is needed by the use

35、r 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 affected if the machine is connected to a poorly designed or constructed drainage system. The purchaser is therefore reco

36、mmended 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. In respect of the potential adverse effects on the quality of water intended for human consumption caused by the washe

37、r-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 wit

38、hout restriction in any of the member states of the EU or EFTA. 4 DIN EN ISO 15883-3:2009-09 EN ISO 15883-3:2009 (E) 1 Scope This part of ISO 15883 specifies particular requirements for washer-disinfectors (WD) that are intended to be used for emptying, flushing, cleaning and thermal disinfection of

39、 containers used to hold human waste for disposal by one operating cycle. This part of ISO 15883 is to be applied in conjunction with ISO 15883-1. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition

40、cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 15883-1:2006, Washer-disinfectors Part 1: General requirements, definitions and tests ISO/TS 15883-5, Washer-disinfectors Part 5: Test soils and methods for demonstrating clea

41、ning efficacy 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 15883-1 and the following apply. 3.1 A0equivalent time in seconds at 80 C, delivered by the disinfection process, with reference to a microorganism with a z value of 10 K ISO 15883-1:2006,

42、 definition 3.1 NOTE See also ISO 15883-1:2006, Annex B. 3.2 emptying discharging the contents of a container by gravity 3.3 human waste excretions and body fluids including faeces, urine, blood, pus, vomit and mucus 5 DIN EN ISO 15883-3:2009-09 EN ISO 15883-3:2009 (E) 3.4 human waste container re-u

43、sable vessel for holding and transporting human waste 4 Performance requirements 4.1 General 4.1.1 The requirements of ISO 15883-1:2006 apply with the exception of its subclause 4.3.2 (which refers to chemical disinfection, see Scope of this part of ISO 15883); subclause 4.3.3 (which refers to the m

44、aximum range of temperatures permitted on the load items, see 4.1.4 of this part of ISO 15883); subclause 5.3.1.2 (which refers to the use of a machine purging and disinfection); subclause 5.7.4 (which refers to verification of the dose of process chemical admitted); subclause 5.7.5 (which specifies

45、 the accuracy and reproducibility of chemical dosing systems); subclause 5.8 (which refers to load temperature protection); subclause 5.9 (which refers to control of temperatures on the load and chamber walls, see 4.5.3 and 4.5.4 of this part of ISO 15883); subclause 6.8.5 (which refers to tests for

46、 load temperature protection); subclause 6.10.3.2 (which refers to protein residue tests, see also ISO 15883-1:2006, Table A.1 (load, 6.10.3) and Annex A of this part of ISO 15883). 4.1.2 The WD shall be designed to process either one type of human waste container or a variety of types of human wast

47、e container and the re-usable supports for single-use bedpans. NOTE This can require the use of two or more types of load carrier. 4.1.3 The WD shall be designed to process either one human waste container per cycle, or several human waste containers per cycle. 4.1.4 The temperature attained on the

48、surfaces of the load during the disinfection stage shall not be less than the disinfection temperature. 4.2 Chemical dosing systems 4.2.1 Provision shall be made for the installation of a chemical dosing system, when specified by the purchaser, to allow for the injection of a descalant, detergent an

49、d/or rinse aid. 4.2.2 The means to control the volume of additive(s) admitted shall be adjustable and shall deliver the set volume to an accuracy of 10 % or better. 4.2.3 The WD shall either be fitted with means to ensure that a fault is indicated when insufficient process chemical(s) has/have been admitted, or it shall be possible for the operator to visually verify that the required amount of process chemical(s) has/have been used. 6 DIN EN ISO 15883-3:2009-09 EN ISO 15883-3:2009 (E) 4.3 Empty