BS EN ISO 15883-4-2009 Washer-disinfectors - Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes《清洗消毒器 不耐热内诊镜使用化学品消毒的清洗消毒器的试验.pdf

1、BS EN ISO15883-4:2009ICS 11.080.10NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDWasher-disinfectorsPart 4: Requirements and testsfor washer-disinfectors employingchemical disinfection for thermolabileendoscopes (ISO 15883-4:2008)This British Standardwas publis

2、hed underthe authority of theStandards Policy andStrategy Committee on 30September 2009 BSI 2009ISBN 978 0 580 66661 2Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 15883-4:2009National forewordThis British Standard is the UK implementation of EN ISO15883-4:2009. It is identica

3、l to ISO 15883-4:2008. It supersedes BS ENISO 15883-4:2008 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee LBI/35, Sterilizers, autoclaves and disinfectors.A list of organizations represented on this committee can be obtained onrequest to its secretary.

4、This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 15883-4June 2009ICS 11.080.1

5、0 Supersedes EN ISO 15883-4:2008 English VersionWasher-disinfectors - Part 4: Requirements and tests forwasher-disinfectors employing chemical disinfection forthermolabile endoscopes (ISO 15883-4:2008)Laveurs dsinfecteurs - Partie 4: Exigences et essais pourles laveurs dsinfecteurs destins la dsinfe

6、ctionchimique des endoscopes thermolabiles (ISO 15883-4:2008)Reinigungs-Desinfektionsgerte - Teil 4: Anforderungenund Prfverfahren fr Reinigungs-Desinfektionsgerte mitchemischer Desinfektion fr thermolabile Endoskope (ISO15883-4:2008)This European Standard was approved by CEN on 16 May 2009.CEN memb

7、ers 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 be obtained on application

8、 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 Management Centre has the s

9、ame 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, Norway, Poland, Portugal,Rom

10、ania, 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 by any means reservedworl

11、dwide for CEN national Members.Ref. No. EN ISO 15883-4:2009: EBS EN ISO 15883-4:2009EN ISO 15883-4:2009 (E) 3 Foreword The text of ISO 15883-4:2008 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” of the International Organization for Standardization (ISO)

12、and has been taken over as EN ISO 15883-4:2009 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 by endorsement, at the l

13、atest 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 for identifying any or all

14、 such patent rights. This document supersedes EN ISO 15883-4:2008. 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 Directive, see informative

15、 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, Denmark, Estonia, Finland, Fran

16、ce, 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 15883-4:2008 has been approved by CEN as a EN ISO 158

17、83-4:2009 without any modification. BS EN ISO 15883-4:2009EN ISO 15883-4:2009 (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 CEN by the European Commis

18、sion 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 been implemented as a natio

19、nal 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 EFTA regulations. Table ZA.

20、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 1, 2, 3, 4, 5, 6, 7.1, 7.2, 7.3, 7.5, 7.6, 8.1, 9.1, 9.2, 9.3, 12.1, 12.5

21、, 12.6, 12.7.1, 12.7.3, 12.7.5, 13.1, 13.3, 13.4, 13.6 The WD shall comply with the requirements of ISO 15883-1:2006 4.1.2 1, 3, 4, 6, 7.1, 7.2, 7.5, 8.1, 9.1 4.1.3 1, 3, 4, 6, 7.1,7.2, 7.5, 8.1, 9.1 4.1.4 13.3 i), 13.3 k) 4.1.5 7.3, 8.1 4.1.6 7.3, 8.1 4.1.7 3, 7.3, 8.1, 9.1 4.1.8 13.4, 13.6 h), 13.

22、3 k), 13.3 m) 4.2 3, 7.3, 7.5, 7.6, 8.1 4.3 3, 8.1 4.4 3, 8.1 4.5 3, 8.1 4.6 3, 8.1 4.7 3, 8.1 4.8 3, 9.1, 9.2 4.9 13.1, 13.6 d) 5.1 3, 9.1, 12.7.5 BS EN ISO 15883-4:2009EN ISO 15883-4:2009 (E) 5 Table ZA.1 (continued) Clauses/subclauses of this European Standard Essential requirements (ERs) of EU D

23、irective 93/42/EEC Qualifying remarks/Notes 5.2 3, 8.1, 13.1 5.3 7.2, 7.5, 8.1 5.4 3, 8.15.5 8.15.6 2, 3 6.2 1, 2, 3, 6, 7.1, 8.1 Testing for conformity 6.3 3, 9.1 Testing for conformity 6.4 3, 7.3, 8.1, 9.1 Testing for conformity 6.5 3, 7.5, 8.1, 9.1 Testing for conformity 6.6 3, 7.5, 8.1 Testing f

24、or conformity 6.7 3, 8.1 Testing for conformity 6.8 3, 8.1 Testing for conformity 6.9 3, 8.1 Testing for conformity 6.10 3, 8.1 Testing for conformity 6.11 3, 8.1 Testing for conformity 6.12 3, 8.1 7 13 The requirements of ISO 15883-1:2006 apply. 8 13.1, 13.3, 13.4, 13.6 In addition, the requirement

25、s of ISO 15883-1:2006 apply. 9 5, 13 The requirements of ISO 15883-1:2006 apply. 10 1, 3 In addition, the requirements of ISO 15883-1:2006 apply. - 12.1a) This relevant Essential Requirement is not addressed in this European Standard 7, 8, 9 13.3 a) This relevant Essential Requirement is partly addr

26、essed 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) falling within the scope of this standard. BS EN ISO 15883-4:2009EN ISO 15883-4:2009 (E) 6

27、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 essential requirements of Directive 2006/42/EC on Machinery to the extent to which they are

28、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 thus does not provide presumption of conformity for the machinery directive. Table ZA.2 Relev

29、ant 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) of this EN Essential Health and SafetyRequirements (EHSRs) ofDirective 2006/42/EC Qualifyin

30、g 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 Standard 4.1.1 1.1.3, 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,

31、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 are not addressed in this Standard BS EN ISO 15883-4:2009ISO 15883-4:2008(E) ISO 2008 All rights reserved iiiContents Page Foreword. v Introduction . vi 1 Scop

32、e . 1 2 Normative references . 2 3 Terms and definitions. 2 4 Performance requirements 3 4.1 General. 3 4.2 Systems for leak testing 4 4.3 Cleaning. 6 4.4 Disinfecting . 7 4.5 Final (post-disinfection) rinsing 9 4.6 Purging to remove rinse water 9 4.7 Drying. 9 4.8 Self-disinfection 10 4.9 Water tre

33、atment equipment . 11 5 Mechanical and process requirements 12 5.1 Materials Design, manufacture and construction. 12 5.2 Device channel irrigation system 12 5.3 Venting and drainage systems 13 5.4 Temperature control. 14 5.5 Process chemicals 14 5.6 Process verification 14 5.7 Dosing systems 14 6 T

34、esting for conformity 14 6.1 General. 14 6.2 Test equipment . 15 6.3 Water used for final (post-disinfection) rinsing. 15 6.4 Hardness of water used during type testing 15 6.5 Leak test 16 6.6 Channels non-obstruction test 18 6.7 Channels non-connection test 19 6.8 Load dryness. 20 6.9 Thermometric

35、tests. 20 6.10 Chemical dosing tests 21 6.11 Tests of cleaning efficacy 22 6.12 Test of disinfection efficacy 23 7 Documentation and inspection . 27 8 Information to be supplied by the manufacturer. 27 9 Marking, labelling and packaging . 28 10 Information to be requested from the purchaser by the m

36、anufacturer 28 Annex A (informative) Summary of activities covered by this Part of ISO 15883 29 Annex B (normative) Microbiological testing of the efficacy of chemical disinfection of the load. 31 Annex C (informative) Summary of test programmes 34 Annex D (normative) Methods for microbiological eva

37、luation of disinfection of liquid transport system 35 BS EN ISO 15883-4:2009ISO 15883-4:2008(E) iv ISO 2008 All rights reservedAnnex E (normative) Tests for microbial contamination of post-disinfection rinse water. 40 Annex F (informative) Typical specifications of trumpet valves and connection port

38、s 41 Annex G (informative) Additional notes on microbiological testing of chemical disinfection processes. 46 Bibliography . 48 BS EN ISO 15883-4:2009ISO 15883-4:2008(E) ISO 2008 All rights reserved vForeword ISO (the International Organization for Standardization) is a worldwide federation of natio

39、nal 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 represented on that committee. Internati

40、onal 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 drafted in accordance with the rul

41、es 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 Standard requires approval by at

42、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 15883-4 was prepared by Technical Committee ISO/T

43、C 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 definitions and tests Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instr

44、uments, 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 chemical disinfection for thermolabile

45、endoscopes Part 5: Test soils and methods for demonstrating cleaning efficacy BS EN ISO 15883-4:2009ISO 15883-4:2008(E) vi ISO 2008 All rights reservedIntroduction It is recommended that this introduction be read in conjunction with the introduction to ISO 15883-1. The washer-disinfectors specified

46、in this part of ISO 15883 are intended to process devices which can be immersed in water or aqueous solutions. For some devices this will require that, prior to processing, relevant parts of the device are protected from immersion in accordance with the device manufacturers operating instructions. F

47、ields of application within the scope of the ISO 15883 series include 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 immun

48、ologically compromised patients. Requirements for washer-disinfectors for other applications are specified in other parts of ISO 15883. Safety requirements for washer-disinfectors are given in IEC 61010-2-040. With respect to the potential adverse effects on the quality of water intended for human c

49、onsumption 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 15883-4:2009INTERNATIONAL STANDARD ISO 15883-4:2008(E) ISO 2008 All rights reserved 1Washer-disinfectors Part 4: Requirements and tes