DIN EN ISO 15883-6-2016 Washer-disinfectors - Part 6 Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive non-critical medical devices and.pdf

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1、April 2016 English price group 12No part of this translation 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!%Q(“2469705www.din.deDIN

2、 EN ISO 15883-6Washer-disinfectors Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011);English version EN ISO 15883-6:2015,English translation of DIN EN ISO 15883-6:2016-04Rei

3、nigungs-Desinfektionsgerte Teil 6: Anforderungen und Prfverfahren fr Reinigungs-Desinfektionsgerte mit thermischerDesinfektion fr nicht invasive, nicht kritische Medizinprodukte und Zubehr im Gesundheitswesen (ISO 15883-6:2011);Englische Fassung EN ISO 15883-6:2015,Englische bersetzung von DIN EN IS

4、O 15883-6:2016-04Laveurs dsinfecteurs Partie 6: Exigences et essais pour les laveurs dsinfecteurs utilisant une dsinfection thermique pour les dispositifs mdicaux non invasifs, non critiques et pour lquipement de soins de sant (ISO 15883-6:2011);Version anglaise EN ISO 15883-6:2015,Traduction anglai

5、se de DIN EN ISO 15883-6:2016-04SupersedesDIN EN ISO 15883-6:2011-07www.beuth.deDocument comprises 22 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.04.16 DIN EN ISO 15883-6:2016-04 2 A comma is used as the decimal marker. Nat

6、ional foreword The text of ISO 15883-6:2011 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” and has been taken over as EN ISO 15883-6:2015 by Technical Committee CEN/TC 102 “Sterilizers for medical purposes” (Secretariat: DIN, Germany). The responsible Ger

7、man body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-04-09 AA Reinigungs-Desinfektionsgerte. According to Resolution CEN/BT C83/2015, Annex ZA and the European foreword have been updated and published in August 2015 as a ne

8、w edition of EN ISO 15883-6:2015. Thus, this new edition of DIN EN ISO 15883-6 has also been published. This document contains ISO 15883-6:2011, unchanged. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. DIN shall not be held resp

9、onsible for identifying any or all such patent rights. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 15883-1 DIN EN ISO 15883-1 ISO 15883-2 DIN EN ISO 15883-2 ISO 15883-3 DIN EN ISO 15883-3 ISO 15883-4 DIN EN ISO 15883-4 ISO/TS 15883-

10、5 DIN ISO/TS 15883-5 IEC 61010-2-040 DIN EN 61010-2-040 (VDE 0411-2-040) Amendments This standard differs from DIN EN ISO 15883-6:2011-07 as follows: a) the European foreword has been updated; b) Annex ZA (informative) “Relationship between this European Standard and the Essential Requirements of EU

11、 Directive 93/42/EEC on medical devices” has been updated. Previous editions DIN EN ISO 15883-6: 2011-07 DIN EN ISO 15883-6:2016-04 3 National Annex NA (informative) Bibliography DIN EN ISO 15883-1, Washer-disinfectors Part 1: General requirements, terms and definitions and tests DIN EN ISO 15883-2,

12、 Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. DIN EN ISO 15883-3, Washer-disinfectors Part 3: Requirements and tests for washer-disinfecto

13、rs employing thermal disinfection for human waste containers DIN EN ISO 15883-4, Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes DIN ISO/TS 15883-5, Washer-disinfectors Part 5: Test soils and methods for demonstra

14、ting cleaning efficacy DIN EN 61010-2-040 (VDE 0411-2-040), 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 15883-6:2016-04 4 This page is

15、intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15883-6 August 2015 ICS 11.080.10 Supersedes EN ISO 15883-6:2011English Version Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medi

16、cal devices and healthcare equipment (ISO 15883-6:2011) Laveurs dsinfecteurs - Partie 6: Exigences et essais pour les laveurs dsinfecteurs utilisant une dsinfection thermique pour les dispositifs mdicaux non invasifs, non critiques et pour lquipement de soins de sant(ISO 15883-6:2011) Reinigungs-Des

17、infektionsgerte - Teil 6: Anforderungen und Prfverfahren fr Reinigungs-Desinfektionsgerte mit thermischer Desinfektion fr nicht invasive, nicht kritische Medizinprodukte und Zubehr im Gesundheitswesen(ISO 15883-6:2011) This European Standard was approved by CEN on 4 August 2015. CEN members are boun

18、d to comply 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 CE

19、N-CENELEC 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 translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre h

20、as the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, L

21、uxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Br

22、ussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 15883-6:2015 EContents Page European foreword 3 Introduction.5 1 Scope6 2 Normative references6 3 Terms and definitions .7 4 Performance requirements.7 4.1 General .7

23、4.2 Cleaning .8 4.3 Disinfecting 8 5 Mechanical and control requirements.9 5.1 Control systems 9 5.2 Process verification 9 6 Testing for conformity 9 6.1 General .9 6.2 Tests for soil removal from chamber walls, load carrier and load.9 6.3 Thermometric tests .10 7 Information to be supplied by the

24、manufacturer .10 8 Information to be requested from the purchaser by the supplier of the WD 10 Annex A (informative) Summary of test programmes.11 Bibliography18 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical dev

25、ices .12 DIN EN ISO 15883-6:2016-04EN ISO 15883-6:2015 (E) 2Foreword .4 - European foreword This document (EN ISO 15883-6:2015) has been prepared by Technical Committee ISO/TC 198 “Sterilization of healthcare products” in collaboration with CEN/TC 102 “Sterilizers for medical purposes”, the secretar

26、iat 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 February 2016, and conflicting national standards shall be withdrawn at the latest by February 2016. Attention is drawn

27、 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 15883-6:2011. This document has been prepared under a mandate given to C

28、EN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. The following referenced documents are indispensable for the app

29、lication of this document. For undated references, the latest edition of the referenced document (including any amendments) applies. For dated references, only the edition cited applies. However, for any use of this standard within the meaning of Annex ZA, the user should always check that any refer

30、enced document has not been superseded and that its relevant contents can still be considered the generally acknowledged state-of-art. When an IEC or ISO standard is referred to in the ISO standard text, this should be understood as a normative reference to the corresponding EN standard, if availabl

31、e, and otherwise to the dated version of the ISO or IEC standard as listed below. NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. Table Correlation between normative references and dated EN and ISO

32、standards Normative references as listed in Clause 2 of the ISO standard Equivalent dated standard EN ISO ISO 15883-1 EN ISO 15883-1:2009+A1:2014 ISO 15883-1:2006+Amd1:2014 ISO/TS 15883-5 CEN/ISO/TS 15883-5:2005 ISO/TS 15883-5:2005 According to the CEN-CENELEC Internal Regulations, the national stan

33、dards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, L

34、uxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 15883-6:2011 has been approved by CEN as EN ISO 15883-6:2015 without any modification. DIN EN ISO 15883-6:2016-04 EN ISO

35、 15883-6:2015 (E) 3 Foreword ISO (the International Organization for Standardization) is 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 s

36、ubject for which a technical committee has been established has the right to be represented 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

37、(IEC) on all matters of electrotechnical standardization. International Standards are drafted 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 comm

38、ittees are circulated to the member bodies for voting. Publication as an International Standard 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

39、be held responsible for identifying any or all such patent rights. ISO 15883-6 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. ISO 15883 consists of the following parts, under the general title Washer-disinfectors: Part 1: General requirements, terms and defini

40、tions 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 thermal disinfection for human w

41、aste 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 washer-disinfectors employing thermal disin

42、fection for non-invasive, non-critical medical devices and healthcare equipment DIN EN ISO 15883-6:2016-04EN ISO 15883-6:2015 (E) 4 Introduction It is intended that this Introduction be read in conjunction with the Introduction to ISO 15883-1. This part of ISO 15883 is the sixth of a series specifyi

43、ng the performance of washer-disinfectors and specifies the particular requirements for performance applicable to general-purpose washer-disinfectors. Its requirements apply to washer-disinfectors used for the cleaning and disinfection of non-invasive and non-critical reusable medical devices (i.e.

44、not penetrating skin or contacting mucosal surfaces) and for other items for use without further treatment in healthcare settings. Such reusable items need to be cleaned and disinfected, but their processing in a washer-disinfector for surgical instruments (see ISO 15883-2), for human waste containe

45、rs (see ISO 15883-3) or for endoscopes (see ISO 15883-4) is inappropriate and/or impractical. Some examples are non-invasive medical devices, washbowls, cleaning equipment (buckets), footwear, container systems used to transport medical devices, including trolleys and transport carts, and bedsteads,

46、 wheelchairs, aids for the disabled. Fields of application within the scope of ISO 15883 include laboratory, veterinary and dental use, and other specific applications such as washer-disinfectors for the disinfection of crockery and cutlery intended for use with immunologically compromised patients.

47、 Requirements for washer-disinfectors for other applications are specified in other parts of ISO 15883. The efficacy of disinfection can be impaired if soil removal is incomplete before the start of the disinfection process. It is desirable that manufacturers of washer-disinfectors be very clear abo

48、ut the items that can be processed in the washer-disinfector, and that reference be made to the instructions for reprocessing provided by the manufacturer of the items to be processed. In respect of the potential adverse effects on the quality of water intended for human consumption caused by the washer-disinfectors, it is noteworthy that a) until verifiable international criteria are adopted, existing national regulations concerning the use and/or the characteristics of the washer-disinfectors remain in force, and b) the ISO 15883 series of standards pro