DIN EN ISO 15883-1-2014 Washer-disinfectors - Part 1 General requirements terms and definitions and tests (ISO 15883-1 2006 + Amd 1 2014) German version EN ISO 15883-1 2009 + A1 20.pdf

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1、October 2014Translation by DIN-Sprachendienst.English price group 29No 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

2、 11.080.10!%;7“2249420www.din.deDDIN EN ISO 15883-1Washer-disinfectors Part 1: General requirements, terms and definitions and tests(ISO 15883-1:2006 + Amd 1:2014);English version EN ISO 15883-1:2009 + A1:2014,English translation of DIN EN ISO 15883-1:2014-10Reinigungs-Desinfektionsgerte Teil 1: All

3、gemeine Anforderungen, Begriffe und Prfverfahren (ISO 15883-1:2006 +Amd 1:2014);Englische Fassung EN ISO 15883-1:2009 + A1:2014,Englische bersetzung von DIN EN ISO 15883-1:2014-10Laveurs dsinfecteurs Partie 1: Exigences gnrales, termes et dfinitions et essais (ISO 15883-1:2006 +Amd 1:2014);Version a

4、nglaise EN ISO 15883-1:2009 + A1:2014,Traduction anglaise de DIN EN ISO 15883-1:2014-10SupersedesDIN EN ISO 15883-1:2009-09www.beuth.deDocument comprises 87 pagesIn case of doubt, the German-language original shall be considered authoritative.10.14 DIN EN ISO 15883-1:2014-10 2 A comma is used as the

5、 decimal marker. National foreword This document (EN ISO 15883-1:2014) has been prepared by Technical Committee 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 Germ

6、an body involved in its preparation was the DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working 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.

7、The start and finish of text introduced or altered by amendment is indicated in the text by tags !“. 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-

8、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 waste containers Part 4: Requirements and tests for washer-

9、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 disinfection for non-invasive, non-critical medical devices and

10、 healthcare equipment Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (draft stage) The DIN Standards corresponding to the International Standards referred to in this document

11、are as follows: ISO 228-1 DIN EN ISO 228-1 ISO 7000 DIN ISO 7000 ISO 9000 DIN EN ISO 9000 ISO 9001 DIN EN ISO 9001 ISO 10012 DIN EN ISO 10012 ISO 10993 DIN EN ISO 10993 ISO 11138-1 DIN EN ISO 11138-1 ISO 11737-1 DIN EN ISO 11773-1 ISO 11737-2 DIN EN ISO 11773-2 ISO 12100 DIN EN ISO 12100 ISO 13485 D

12、IN EN ISO 13485 ISO 13849-2 DIN EN ISO 13849-2 ISO 14644-3 DIN EN ISO 14644-3 ISO 14698-1 DIN EN ISO 14698-1 DIN EN ISO 15883-1:2014-10 3 ISO 14971 DIN EN ISO 14971 ISO 17665-1 DIN EN ISO 17665-1 IEC 60073 DIN EN 60073 IEC 60584-1:1995 DIN EN 60584-1:1996 IEC 60751 DIN EN 60751 IEC 61010-2-040 DIN E

13、N 61010-2-040 IEC 61326-1:2005 DIN EN 61326-1:2006 IEC 61508-1 DIN EN 61508-1 Amendments This standard differs from DIN EN ISO 15883-1:2009-09 as follows: a) Amendment A1:2014 has been incorporated, including the following corrections: normative references, the Bibliography and cross references in t

14、he text have been revised and updated; terms and definitions have been revised (“D10-value” and “z-value” have been added) and references to ISO/TS 11139 have been updated; Subclause 5.2 “Safety” has been revised to be in conformity with the corresponding essential requirements of EU Directive 93/42

15、/EEC on medical devices; in Subclause 5.20 “Microprocessor control systems”, requirements for software have been included; in Subclause 8.3 “At delivery of the WD”, requirements for the instructions for use and address data to be provided by the manufacturer have been supplemented; Annex ZA (informa

16、tive) concerning 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/E

17、EC on the 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; b) terms and definitions of the German translation based on ISO/TS 11139 have been alig

18、ned with DIN EN ISO 17665-1. Previous editions DIN EN ISO 15883-1: 2006-07, 2009-09 DIN EN ISO 15883-1:2014-10 4 National Annex NA (informative) Bibliography DIN EN 60073, Basic and safety principles for man-machine interface, marking and identification Coding principles for indicators and actuators

19、 DIN EN 60571, Industrial platinum resistance thermometers and platinum temperature sensors DIN EN 60584-1:1996, Thermocouples Part 1: Reference tables DIN EN 61010-2-040, Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-040: Particular requirements for

20、 sterilizers and washer-disinfectors used to treat medical materials DIN EN 61326-1:2006, Electrical equipment for measurement, control and laboratory use EMC requirements Part 1: General requirements DIN EN 61508-1, Functional safety of electrical/electronic/programmable electronic safety-related s

21、ystems Part 1: General requirements DIN EN ISO 228-1, Pipe threads where pressure-tight joints are not made on the threads Part 1: Dimensions, tolerances and designation DIN EN ISO 9000, Quality management systems Fundamentals and vocabulary DIN EN ISO 9001, Quality management systems Requirements D

22、IN EN ISO 10012, Measurement management systems Requirements for measurement processes and measuring equipment DIN EN ISO 10993 (all parts), Biological evaluation of medical devices DIN EN ISO 11138-1, Sterilization of health care products Biological indicators Part 1: General requirements DIN EN IS

23、O 11773-1, Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products DIN EN ISO 11773-2, Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a

24、 sterilization process DIN EN ISO 12100, Safety of machinery General principles for design Risk assessment and risk reduction DIN EN ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes DIN EN ISO 13849-2, Safety of machinery Safety-related parts of control syst

25、ems Part 2: Validation DIN EN ISO 14644-3, Cleanrooms and associated controlled environments Part 3: Test method DIN EN ISO 15883-1:2014-10 5 DIN EN ISO 14698-1, Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles DIN EN ISO 14971, Medical devices Ap

26、plication of risk management to medical devices DIN EN ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices DIN ISO 7000, Graphical symbols for use on equipment Index and syno

27、psis DIN EN ISO 15883-1:2014-10 6 This page is intentionally blank EN ISO 15883-1 June 2009 + A1 July 2014 ICS 11.080.10 Supersedes EN ISO 15883-1:2006English Version Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006 + Amd 1:2014) Laveurs dsinfecte

28、urs - Partie 1: Exigences gnrales, termes et dfinitions et essais (ISO 15883-1:2006 + Amd 1:2014) Reinigungs-Desinfektionsgerte - Teil 1: Allgemeine Anforderungen, Begriffe und Prfverfahren (ISO 15883-1:2006 + Amd 1:2014)EN ISO 15883-1:2009 was approved by CEN on 2009-05-16 and Amendment A1:2014 on

29、2014-06-21. CEN members are bound 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 o

30、btained on application to the CEN-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

31、 CEN-CENELEC Management Centre has 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, Irel

32、and, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved

33、worldwide for CEN national Members. Ref. No. EN ISO 15883-1:2009 + A1:2014 EEUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 15883-1:2009 + A1:2014 (E) 2 DIN EN ISO 15883-1:2014-10 Contents PageFor

34、eword to EN ISO 15883-1:2006 .4!Foreword to EN ISO 15883-1:2009/A1:2014“ 5Introduction .61 Scope 72 Normative references 73 Terms and definitions .84 Performance requirements .144.1 General 144.2 Cleaning 154.3 Disinfection 164.4 Rinsing 174.5 Drying 174.6 Process chemicals 185 Mechanical and proces

35、s requirements .185.1 Materials, design and manufacture/construction .185.2 Safety 195.3 Calorifiers and tanks .205.4 Loading and unloading doors and their controls .215.5 Pipework and fittings 235.6 Spray systems 235.7 Dosing systems .245.8 Load temperature protection 245.9 Process temperature cont

36、rol limits .255.10 Switches, gauges and indicating devices .265.11 Process verification .265.12 Instrumentation and controls .275.13 Temperature indicating systems 285.14 Pressure indicating systems 295.15 Timing equipment 295.16 Operating cycle indicating equipment 295.17 Recording instruments (if

37、fitted) 295.18 Control systems .315.19 Override of automatic control 325.20 Microprocessor control systems .335.21 Access to software 335.22 Fault indication systems .335.23 Water supply 345.24 Venting and drainage systems .345.25 Drainage 355.26 Air filters installed within the WD .355.27 Load hand

38、ling and supports for use within the WD 355.28 Trolleys .365.29 Environment .376 Testing for conformity .376.1 General 376.2 Test equipment 406.3 Tests on doors, interlocks and fault indications 416.4 Tests on water quality and water volume .436.5 Tests on pipework .456.6 Tests on instrumentation fi

39、tted to the WD 47EN ISO 15883-1:2009 + A1:2014 (E) 3 DIN EN ISO 15883-1:2014-10 Page6.7 Tests on load carriers . 486.8 Thermometric tests . 496.9 Chemical dosing tests 526.10 Tests of cleaning efficacy . 536.11 Tests of air quality . 546.12 Load dryness test 556.13 Automatic control test 557 Documen

40、tation 568 Information to be supplied by the manufacturer . 568.1 General . 568.2 Before delivery of the WD and for installation . 578.3 At delivery of the WD 589 Marking, labelling and packaging 599.1 Marking and labelling 599.2 Packaging . 5910 Information to be requested from the purchaser by the

41、 supplier of the WD 60Annex A (informative) Test programme 61Annex B (informative) A0concept Comparative lethality of moist heat processes 65Annex C (normative) Test methods for the detection and assessment of residual proteinaceous contamination 69Annex D (normative) Microbiological recovery medium

42、 for estimation of bacterial contamination of water . 74Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices . 75Bibliography 79EN ISO 15883-1:2009 + A1:2014 (E) Foreword to EN ISO 15883-1:2006 The text of ISO

43、15883-1:2006 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 15883-1:2009 by Technical Committee CEN/TC 102 “Sterilizers for medical purposes” the secretariat of

44、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 withdrawn at the latest by March 2010. Attention is drawn to the po

45、ssibility 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 has been prepared under a mandate given to CEN by the European Commission and the European Free Trad

46、e Association, and supports essential requirements of EU Directive(s). This document supersedes EN ISO 15883-1:2006. For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards

47、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, Luxembourg, Malta, Netherlands, Norway, Poland, Portuga

48、l, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 15883-1:2006 has been approved by CEN as EN ISO 15883-1:2009 without any modification. 4 DIN EN ISO 15883-1:2014-10 EN ISO 15883-1:2009 + A1:2014 (E) !Foreword to EN ISO 15883-1:2009

49、/A1:2014This document (EN ISO 15883-1:2009/A1:2014) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” in collaboration with Technical Committee CEN/TC 102 “Sterilizers for medical purposes” the secretariat of which is held by DIN. This Amendment to the European Standard EN ISO 15883-1:2009 shall be given the status of a national standard, either by publi