DIN EN ISO 15883-2-2009 Washer-disinfectors - Part 2 Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments anaesthetic equipment bo.pdf

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1、September 2009DEUTSCHE NORM English price group 11No 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!$Ybn“15463

2、75www.din.deDDIN EN ISO 15883-2Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employingthermal disinfection for surgical instruments, anaesthetic equipment,bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006)English version of DIN EN ISO 15883-2:2009-09R

3、einigungs-Desinfektionsgerte Teil 2: Anforderungen und Prfverfahren von Reinigungs-Desinfektionsgerten mitthermischer Desinfektion fr chirurgische Instrumente, Ansthesiegerte, Gefe,Utensilien, Glasgerte usw. (ISO 15883-2:2006)Englische Fassung DIN EN ISO 15883-2:2009-09SupersedesDIN EN ISO 15883-2:2

4、006-07See start of validitywww.beuth.deDocument comprises 22 pagesDIN EN ISO 15883-2:2009-09 2 Start of validity This standard takes effect on 1 September 2009. DIN EN ISO 15883-2:2006-07 may be used in parallel until 21 March 2010. National foreword This standard has been prepared by Technical Comm

5、ittee ISO/TC 198 “Sterilization of health care products” in collaboration with Technical Committee CEN/TC 102 “Sterilizers for medical purposes” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Technic

6、al Committee NA 063-04-09 AA Reinigungs-Desinfektionsgerte. This standard contains specifications meeting the 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 req

7、uirements, terms and definitions and tests Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. Part 3: Requirements and tests for washer-disinfectors employing therm

8、al disinfection for human waste containers Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes Part 5: Test soils and methods for demonstrating cleaning efficacy Technical Specification Part 6: Requirements and tests for general purpose

9、washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (at present at the stage of draft) The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 4017 DIN EN ISO 4017 ISO 5356-

10、2 DIN EN ISO 5356-2 ISO 17664 DIN EN ISO 17664 IEC 61010-2-045 DIN EN 61010-2-0451)1)Withdrawn; replaced by: DIN EN 61010-2-040. DIN EN ISO 15883-2:2009-09 3 Amendments This standard differs from DIN EN ISO 15883-2:2006-07 as follows: a) Annex ZA (informative) concerning the relationship between thi

11、s 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 approximation of the laws of the Me

12、mber 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. Previous editions DIN EN ISO 15883-2: 2006-07 National Annex NA (informative) Bibliography DIN EN ISO 4017, Hexagon head screws Prod

13、uct grades A and B DIN EN ISO 5356-2, Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weight-bearing connectors DIN EN ISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices DIN E

14、N 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 15883-2:2009-09 4 This page is intentionally blank EUROPEAN STANDARD NORME EU

15、ROPENNE EUROPISCHE NORM EN ISO 15883-2 June 2009 ICS 11.080.10 Supersedes EN ISO 15883-2:2006 English Version Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensil

16、s, glassware, etc. (ISO 15883-2:2006) Laveurs dsinfecteurs - Partie 2: Exigences et essais pour laveurs dsinfecteurs destins la dsinfection thermique des instruments chirurgicaux, du matriel danesthsie, des bacs, plats, rcipients, ustensiles, de la verrerie, etc. (ISO 15883-2:2006) Reinigungs-Desinf

17、ektionsgerte - Teil 2: Anforderungen und Prfverfahren von Reinigungs-Desinfektionsgerten mit 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 c

18、omply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status 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 Mana

19、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 translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as

20、the official 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, Slova

21、kia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE 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

22、for CEN national Members. Ref. No. EN ISO 15883-2:2009: EContents 2 EN ISO 15883-2:2009 (E) DIN EN ISO 15883-2:2009-09 Page Foreword3 Introduction 4 1 Scope .6 3 Terms and definitions .7 4.1 General7 4.2 Cleaning8 4.3 Disinfecting .8 4.4 Temperature of internal surfaces of processed devices.9 5 Mech

23、anical and control requirements.9 5.1 Load connectors .9 5.2 Control systems 10 5.3 Process verification 10 6 Testing for conformity 10 6.1 General. 10 6.2 Tests for soil removal from chamber walls, load carrier and load . 10 6.3 Thermometric tests 11 7 Information to be supplied by the manufacturer

24、. 13 8 Information to be requested from the purchaser by the supplier of the WD . 13 Annex A (informative) Summary of test programmes . 14 Bibliography 15 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC. 16 2 Normative refer

25、ences .6 4 Performance requirements 7 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 taken over as EN ISO 15883-2:2009 by Technical Committee CE

26、N/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 with

27、drawn 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 15883-2:2006. This

28、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 the

29、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, Lithuania

30、, 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 without any modification. 3 EN ISO 15883-2:2009 (E) DIN EN ISO

31、 15883-2:2009-09 Introduction 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 series of standards specifying the performance of washer-disinfectors and specifies the general requirements for performa

32、nce applicable to instrument washer-disinfectors. The requirements given in this part apply to washer-disinfectors used for cleaning and thermal disinfection of medical devices intended for re-use such as: surgical instruments; powered devices; instrument trays; instruments for minimally invasive su

33、rgery; lumen devices and tubing; rigid endoscopes; anaesthetic and respiratory equipment; bowls, dishes and receivers; glassware; containers for transit. Fields of application within the scope of the ISO 15883 series of standards include laboratory, veterinary, dental and pharmaceutical applications

34、 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 for other applications are specified in other parts of the ISO

35、 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 sterilization. In both cases, the efficacy of the cleaning and disinfection is of major importance. In either case, this is fo

36、r 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 ensuring that the sterilization process is not unduly challenged by residual soil. The efficacy of disinfection can be

37、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, brushing, ultra sonic pre-cleaning, lumen irrigation or any combination of these techniques. Reference should be made to the

38、medical manufacturers instructions for reprocessing (see also ISO 17664). Safety requirements for washer-disinfectors are given in IEC 61010-2-045. 4 EN ISO 15883-2:2009 (E) DIN EN ISO 15883-2:2009-09 In respect of the potential adverse effects on the quality of water intended for human consumption

39、caused by the washer-disinfectors: a) it should be noted 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) the ISO 15883 series of standards provides no information as to wh

40、ether the washer-disinfectors may be used without restriction in any of the member states of the EU or EFTA. 5 EN ISO 15883-2:2009 (E) DIN EN ISO 15883-2:2009-09 1 Scope This part of ISO 15883 specifies particular requirements for washer-disinfectors (WD) that are intended for use for the cleaning a

41、nd thermal disinfection, in a single operating cycle, of re-usable medical devices such as surgical instruments, anaesthetic equipment, bowls, dishes and receivers, utensils and glassware. NOTE 1 Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam or combinatio

42、n of the two. The requirements specified in this part of ISO 15883 are applicable in conjunction with the general requirements specified in ISO 15883-1. The specified performance requirements of this part of ISO 15883 may not ensure the inactivation or removal of the causative agent(s) (prion protei

43、n) of transmissible spongiform encephalopathies. NOTE 2 If it is considered that prion protein can be present, particular care is needed in the choice of disinfectants and cleaning agents to ensure that the chemicals used do not react with the prion protein in a manner that may inhibit its removal o

44、r inactivation. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 4017,

45、Hexagon head screws Product grades A and B ISO 5356-2, Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weight-bearing connectors ISO 5361, Anaesthetic and respiratory equipment Tracheal tubes and connectors ISO 5362, Anaesthetic reservoir bags ISO 5367, Breathing tube

46、s intended for use with anaesthetic apparatus and ventilators ISO 15883-1:2006, Washer-disinfectors Part 1: General requirements, definitions and tests ISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices 6 EN

47、 ISO 15883-2:2009 (E) DIN EN ISO 15883-2:2009-09 ISO/TS 15883-5:2005, Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy EN 10088-2, Stainless steels Part 2: Technical delivery conditions for sheet/plate and strip for general purposes 3 Terms and definitions For t

48、he 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, definition 3.1 NOTE See also ISO 15883-1:2

49、006, Annex B. 3.2 anaesthetic and respiratory accessories respiratory tubes, anaesthetic reservoir bags and other anaesthetic products that will not be sufficiently flushed by rotating spray nozzles, but which require positioning over fixed spray/jet nozzles 3.3 lumen device device that consists of tubes, pipes (either single or coaxial combined) which require connecting to the WD by means of dedicated connectors 3.4 powered device surgical instrument which gives a rotating and/or os