1、November 2015 English price group 11No 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 11.060.20!%GNJ“2364339www.din.d
2、eDIN EN ISO 16954Dentistry Test methods for dental unit waterline biofilm treatment (ISO 16954:2015);English version EN ISO 16954:2015,English translation of DIN EN ISO 16954:2015-11Zahnheilkunde Prfverfahren zur Biofilmbehandlung der wasserfhrenden Leitungen einer zahnrztlichen Behandlungseinheit (
3、ISO 16954:2015);Englische Fassung EN ISO 16954:2015,Englische bersetzung von DIN EN ISO 16954:2015-11Mdecine bucco-dentaire Mthodes dessais pour le traitement du biofilm dans les conduites deau de lunit dentaire (ISO 16954:2015);Version anglaise EN ISO 16954:2015,Traduction anglaise de DIN EN ISO 16
4、954:2015-11www.beuth.deDocument comprises 19 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.10.15DIN EN ISO 16954:2015-11 2 A comma is used as the decimal marker. National foreword This document (EN ISO 16954:2015) has been pr
5、epared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Working Committee NA 014-00-05
6、 AA Zahnrztliche Ausrstung and Working Group NA 014-00-05-04 AK Wasser und Luft. The DIN Standards corresponding to the International Standards referred to in Clause 2 of this standard are as follows: ISO 1942 DIN EN ISO 1942 ISO 3696 DIN ISO 3696 ISO 7494-1 DIN EN ISO 7494-1 ISO 7494-2 DIN EN ISO 7
7、494-2 ISO 19458 DIN EN ISO 19458 IEC 60601-1 DIN EN 60601-1 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 7494-1, Dentistry Dental units Part 1: General requirements and test methods DIN EN ISO 7494-2, Dentistry Dental units Part 2: Air, water, suction
8、 and wastewater systems DIN EN ISO 19458, Water quality Sampling for microbiological analysis DIN EN 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance DIN ISO 3696, Water for analytical laboratory use Specification and test methods EUROPEAN
9、 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 biofilm dans les conduites deau de lunit dentaire (ISO 1
10、6954:2015) 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 CEN/CENELEC Internal Regulations which stipulate the con
11、ditions 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 Centre or to any CEN member. This European Standard exis
12、ts 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 the official versions. CEN members are the national sta
13、ndards 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, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, S
14、lovenia, 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 rights of exploitation in any form and by any means reser
15、ved worldwide for CEN national Members. Ref. No. EN ISO 16954:2015 E European foreword .31 Scope . 42 Normative references 43 Terms and definitions . 44 Treatment methods . 65 Test water and bacterial challenge suspensions . 65.1 Test water 65.1.1 Reagents 65.1.2 Preparation of hardness stock soluti
16、on 1 . 65.1.3 Preparation of hardness stock solution 2 . 65.1.4 Preparation of test water prior to inoculation . 65.2 Bacterial challenge. 75.3 Inoculated test water . 76 Test apparatus . 76.1 Test apparatus design . 86.1.1 General 86.1.2 Considerations specific to antimicrobial materials and materi
17、als which prevent microbial adhesion 96.2 Test apparatus operation . 96.2.1 Flow rates . 96.2.2 Flow patterns (on-off cycles) 96.2.3 Test environment temperature and preconditioning period . 107 Test procedures 107.1 Testing sequence 107.2 Biofilm prevention or inhibition . 107.2.1 General. 107.2.2
18、Pretreatment of the test apparatuses . 117.2.3 Concurrent exposure to inoculated test water and the treatment method for biofilm prevention or inhibition . 117.2.4 Microbiological sampling and testing . 117.2.5 Test duration 117.2.6 Analysis of results 127.3 Biofilm removal . 127.3.1 General. 127.3.
19、2 Initial microbiological sampling and testing 127.3.3 Application of the biofilm removal treatment method 137.3.4 Final microbiological sampling and testing .137.3.5 Analysis of results 138 Microbiological sampling and testing .148.1 Enumeration of bacteria levels in procedural water .148.1.1 Sampl
20、ing.148.1.2 Total viable count test procedure .148.1.3 Alternative total viable count test procedure 148.2 Biofilm on waterline surfaces . 158.2.1 Sampling.158.2.2 Biofilm assessment test procedure .159 Test Report .16Bibliography .17Contents Page2 DIN EN ISO 16954:2015-11 EN ISO 16954:2015 (E)Europ
21、ean foreword This document (EN ISO 16954:2015) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration 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 p
22、ublication of an identical text or by endorsement, at the latest by January 2016, and conflicting national standards shall be withdrawn 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 CENE
23、LEC shall not be held responsible for identifying any or all such patent rights. 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, Croatia, Cyprus, Czech Republ
24、ic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endors
25、ement notice The text of ISO 16954:2015 has been approved by CEN as EN ISO 16954:2015 without any modification. 3DIN EN ISO 16954:2015-11 EN ISO 16954:2015 (E)1 ScopeThis International Standard provides type test methods for evaluating the effectiveness of treatment methods intended to prevent or in
26、hibit the formation of biofilm or to remove biofilm present in dental unit procedural water delivery systems 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
27、 hoses that deliver compressed air within the dental unit.This International Standard does not establish 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 p
28、otentially caused by treatment methods.The test methods provided in this International Standard can be used 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 documen
29、t and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 3696:1987, Water for analytical laboratory use Specification a
30、nd test methodsISO 7494-1, Dentistry Dental units Part 1: General requirements and test methodsISO 7494-2, 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 equi
31、pment Part 1: General requirements for basic safety and essential performance3 Terms and definitionsFor 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 inhabit
32、ing a self-developed extracellular biopolymeric matrix attached to a surface4 DIN EN ISO 16954:2015-11 EN ISO 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 1
33、942:2009, 2.863.3dental unit procedural water delivery systemsystem of components of 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
34、, multifunctional syringe water, scaler procedural water, or rinse cup water.SOURCE: 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
35、of all water-bearing elements of the procedural water delivery system, but not necessarily 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 testi
36、ng prior to the addition of the specified bacterial challenge suspension3.7bacterial 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, contai
37、ning specified amounts of sterilized test water and one or more bacterial challenge 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 tes
38、t groupapparatus used in testing in which a treatment specified by the dental unit manufacturer is applied and any antimicrobial materials specified by the manufacturer are present in the waterline components, unless otherwise specified in the test requirements5DIN EN ISO 16954:2015-11 EN ISO 16954:
39、2015 (E)4 Treatment methodsDepending upon the specific technical 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 forma
40、tion on surfaces within the dental unit procedural water delivery 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 expan
41、ded upon, for example to include additional replicates or test scenarios. 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 t
42、he preparation of test water prior to inoculation.5.1.1 Reagents5.1.1.1 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
43、chloride hydrate.5.1.1.4 Sodium bicarbonate (NaHCO3).5.1.1.5 Tryptic 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 chl
44、oride (5.1.1.2) and 31,7 g of magnesium chloride (5.1.1.3) in 1,00 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 2Dissol
45、ve 56,0 g of sodium bicarbonate (5.1.1.4) in 1,00 l water (5.1.1.1). 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
46、 to inoculationFor each litre of test water to be prepared, add 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 s
47、olution 2 which has been filter-6 DIN EN ISO 16954:2015-11 EN ISO 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 be used within 24 h or stored
48、at (5 3) C for up to one week.NOTE 1 The hardness of the prepared test water is approximately 1,8 mmol of calcium ions per litre (equivalent to approximately 180 mg/l as CaCO3). This corresponds to the upper limit of the generally accepted range for hard water.17NOTE 2 The test water has a concentra
49、tion of approximately 10 mg TSB per litre, which yields a total organic carbon (TOC) level of approximately 4 mg/l, although the exact TOC level might vary somewhat. This approximate TOC level is consistent with the recommended upper limit of 4 mg/l for TOC in chlorinated drinking water1and is included in the test water to reduce the time for biofilm formation.5.2 Bacterial challengeBacterial challenge suspensions used to inoculate the test water shall be prepared with the following bacteria
