EN ISO 16954-2015 en Dentistry - Test methods for dental unit waterline biofilm treatment《牙科 牙科综合治疗机水线生物膜处理的试验方法(ISO 16954 2015)》.pdf

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1、BSI Standards PublicationBS EN ISO 16954:2015Dentistry Test methods fordental unit waterline biofilmtreatmentBS EN ISO 16954:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO16954:2015.The UK participation in its preparation was entrusted to TechnicalComm

2、ittee CH/106/4, Dental Instruments and Equipment.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Stan

3、dards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 75176 9ICS 11.060.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 July 2015.Amend

4、ments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 16954 July 2015 ICS 11.060.20 English Version Dentistry - Test methods for dental unit waterline biofilm treatment (ISO 16954:2015) Mdecine bucco-dentaire - Mthodes dessais pour le traitement du

5、biofilm dans les conduites deau de lunit dentaire (ISO 16954:2015) Zahnheilkunde - Prfverfahren zur Biofilmbehandlung der wasserfhrenden Leitungen einer dentalen Behandlungseinheit (ISO 16954:2015) This European Standard was approved by CEN on 23 April 2015. CEN members are bound to comply with the

6、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-CENELEC Management

7、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 has the same status as

8、 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, Luxembourg, Malta, Net

9、herlands, 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 Brussels 2015 CEN All r

10、ights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 16954:2015 EBS EN ISO 16954:2015EN ISO 16954:2015 (E) 3 European foreword This document (EN ISO 16954:2015) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration

11、 with Technical Committee CEN/TC 55 “Dentistry” 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 January 2016, and conflicting national standards shall be w

12、ithdrawn at the latest by January 2016. 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. According to the CEN-CENELEC Internal Regulati

13、ons, the national standards 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

14、, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 16954:2015 has been approved by CEN as EN ISO 16954:2015 without any modification. BS EN ISO 16954

15、:2015ISO 16954:2015(E)Foreword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Treatment methods . 35 Test water and bacterial challenge suspensions . 35.1 Test water 35.1.1 Reagents 35.1.2 Preparation of hardness stock solution 1 . 35.1.3 Preparation of hardness stock solution 2 .

16、 35.1.4 Preparation of test water prior to inoculation . 35.2 Bacterial challenge. 45.3 Inoculated test water . 46 Test apparatus . 46.1 Test apparatus design . 56.1.1 General 56.1.2 Considerations specific to antimicrobial materials and materials which prevent microbial adhesion 66.2 Test apparatus

17、 operation . 66.2.1 Flow rates . 66.2.2 Flow patterns (on-off cycles) 66.2.3 Test environment temperature and preconditioning period 77 Test procedures . 77.1 Testing sequence . 77.2 Biofilm prevention or inhibition 77.2.1 General 77.2.2 Pretreatment of the test apparatuses 87.2.3 Concurrent exposur

18、e to inoculated test water and the treatment method for biofilm prevention or inhibition 87.2.4 Microbiological sampling and testing 87.2.5 Test duration . 87.2.6 Analysis of results . 97.3 Biofilm removal 97.3.1 General 97.3.2 Initial microbiological sampling and testing . 97.3.3 Application of the

19、 biofilm removal treatment method 107.3.4 Final microbiological sampling and testing .107.3.5 Analysis of results 108 Microbiological sampling and testing .118.1 Enumeration of bacteria levels in procedural water .118.1.1 Sampling. 118.1.2 Total viable count test procedure .118.1.3 Alternative total

20、 viable count test procedure 118.2 Biofilm on waterline surfaces . 128.2.1 Sampling. 128.2.2 Biofilm assessment test procedure .129 Test Report .13Bibliography .14 ISO 2015 All rights reserved iiiContents PageBS EN ISO 16954:2015ISO 16954:2015(E)ForewordISO (the International Organization for Standa

21、rdization) 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 subject for which a technical committee has been established has the right t

22、o 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 (IEC) on all matters of electrotechnical standardization.The procedures use

23、d to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules o

24、f the ISO/IEC Directives, Part 2 (see www.iso.org/directives). 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. Details of any patent rights identifie

25、d during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on t

26、he meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/

27、TC 106, Dentistry, Subcommittee SC 6, Dental equipment.This first edition of ISO 16954:2015 cancels and replaces the first edition of ISO/TS 11080:2009, of which it constitutes a technical revision.iv ISO 2015 All rights reservedBS EN ISO 16954:2015INTERNATIONAL STANDARD ISO 16954:2015(E)Dentistry T

28、est methods for dental unit waterline biofilm treatment1 ScopeThis International Standard provides type test methods for evaluating the effectiveness of treatment methods intended to prevent or inhibit the formation of biofilm or to remove biofilm present in dental unit procedural water delivery sys

29、tems under laboratory conditions.This International Standard does not apply to devices intended to deliver sterile procedural water or sterile solution. It also does not apply to lines, tubing, or hoses that deliver compressed air within the dental unit.This International Standard does not establish

30、 specific upper limits for bacterial contamination or describe test methods to be used in clinical situations. It also does not establish test methods for evaluating any deleterious side effects potentially caused by treatment methods.The test methods provided in this International Standard can be u

31、sed to test other dental equipment that delivers non-sterile water to the oral cavity.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For u

32、ndated references, the latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 3696:1987, Water for analytical laboratory use Specification and test methodsISO 7494-1, Dentistry Dental units Part 1: General requirements and test methodsISO 7494-

33、2, Dentistry Dental units Part 2: Water and air supplyISO 10523, Water quality Determination of pHISO 19458, Water quality Sampling for microbiological analysisIEC 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance3 Terms and definitionsFor

34、the purposes of this document, the terms and definitions given in IEC 60601-1, ISO 1942, ISO 7494-1, and ISO 7494-2 and the following apply.3.1biofilmstructured community of microorganisms inhabiting a self-developed extracellular biopolymeric matrix attached to a surface ISO 2015 All rights reserve

35、d 1BS EN ISO 16954:2015ISO 16954:2015(E)3.2dental unitcombination of interconnected dental equipment and dental instruments constituting a functional assembly for use in the provision of dental treatmentSOURCE: ISO 1942:2009, 2.863.3dental unit procedural water delivery systemsystem of components of

36、 a dental unit which convey water from a supply source to one or more outlets used for dental treatment3.4procedural waterwater supplied by the dental unit for use in the oral cavityEXAMPLE Handpiece procedural water, multifunctional syringe water, scaler procedural water, or rinse cup water.SOURCE:

37、 ISO 7494-2:2003, 3.13.5surrogate dental unit water systemtest apparatus which accurately recreates the procedural water delivery system of a dental unit, including design, construction, configuration, and operation of all water-bearing elements of the procedural water delivery system, but not neces

38、sarily including other dental unit components which do not directly come in contact with or control the flow of procedural water3.6test waterwater having specified chemical and physical characteristics used for testing prior to the addition of the specified bacterial challenge suspension3.7bacterial

39、 challenge suspensionconsortium of specified bacteria suspended in a nutrient growth medium or buffered solution used to inoculate test water3.8inoculated test waterprepared aqueous suspension used in testing, containing specified amounts of sterilized test water and one or more bacterial challenge

40、suspension(s)3.9test apparatus for the control groupapparatus used in testing in which no treatment method is applied and no antimicrobial material is present in the waterline components3.10test apparatus for the test groupapparatus used in testing in which a treatment specified by the dental unit m

41、anufacturer is applied and any antimicrobial materials specified by the manufacturer are present in the waterline components, unless otherwise specified in the test requirements2 ISO 2015 All rights reservedBS EN ISO 16954:2015ISO 16954:2015(E)4 Treatment methodsDepending upon the specific technical

42、 approach of a treatment method and its intended benefits, the performance objectives of a dental unit procedural water delivery system treatment method can include one or both of the following: prevention or inhibition of biofilm formation on surfaces within the dental unit procedural water deliver

43、y system; removal of biofilm from surfaces within the dental unit procedural water delivery system.This International Standard specifies separate test methods for each of the above performance objectives. These requirements can be expanded upon, for example to include additional replicates or test s

44、cenarios. Additions to the test method shall follow the general principles of this International Standard and be fully described in the test report.5 Test water and bacterial challenge suspensions5.1 Test waterThis subclause specifies the preparation of test water prior to inoculation.5.1.1 Reagents

45、5.1.1.1 Water, in accordance with ISO 3696:1987, grade 3.5.1.1.2 Calcium chloride (CaCl2), or an equivalent molar quantity of a calcium chloride hydrate.5.1.1.3 Magnesium chloride (MgCl2), or an equivalent molar quantity of a magnesium chloride hydrate.5.1.1.4 Sodium bicarbonate (NaHCO3).5.1.1.5 Try

46、ptic soy broth (TSB), 1/3-strength, 10,0 g tryptic soy medium per litre broth.5.1.1.6 Sodium hydroxide (NaOH), 1 mol/l.5.1.1.7 Hydrochloric acid (HCl), 1 mol/l.5.1.2 Preparation of hardness stock solution 1Dissolve 74,0 g of calcium chloride (5.1.1.2) and 31,7 g of magnesium chloride (5.1.1.3) in 1,

47、00 l water (5.1.1.1). Hardness stock solution 1 shall be sterilized by heat or filter-sterilized using a 0,2 m microfilter and used within 24 h or stored at (5 3) C for up to 6 months.5.1.3 Preparation of hardness stock solution 2Dissolve 56,0 g of sodium bicarbonate (5.1.1.4) in 1,00 l water (5.1.1

48、.1). Hardness stock solution 2 shall be filter-sterilized using 0,2 m microfilter and used within 24 h or stored at (5 3) C for up to 6 months. Hardness stock solution 2 is not to be heat sterilized.5.1.4 Preparation of test water prior to inoculationFor each litre of test water to be prepared, add

49、1,00 ml of 1/3-strength TSB (5.1.1.5) and 1,80 ml of hardness stock solution 1 (5.1.2) to 1,00 l water (5.1.1.1) and steam sterilize. After the sterilized solution has cooled, for each litre of test water add 4,00 ml of hardness stock solution 2 which has been filter- ISO 2015 All rights reserved 3BS EN ISO 16954:2015ISO 16954:2015(E)sterilized using a 0,2 m microfilter. Adjust the pH to 7,0 to 8,0, measured according to ISO 10523, by adding sodium hydroxide (5.1.1.6) or hydrochloric acid (5.1.1.7). The test water shall b