SVENSK STANDARD SS-EN ISO 16954:2015

Transkript

1 SVENSK STANDARD SS-EN ISO 16954:2015 Fastställd/Approved: Publicerad/Published: Utgåva/Edition: 1 Språk/Language: engelska/english ICS: Tandvård Testmetoder för utvärdering av biofilm behandling i vattensystem i dentala units (ISO 16954:2015) Dentistry Test methods for dental unit waterline biofilm treatment (ISO 16954:2015)

2 Standarder får världen att fungera SIS (Swedish Standards Institute) är en fristående ideell förening med medlemmar från både privat och offentlig sektor. Vi är en del av det europeiska och globala nätverk som utarbetar internationella standarder. Standarder är dokumenterad kunskap utvecklad av framstående aktörer inom industri, näringsliv och samhälle och befrämjar handel över gränser, bidrar till att processer och produkter blir säkrare samt effektiviserar din verksamhet. Delta och påverka Som medlem i SIS har du möjlighet att påverka framtida standarder inom ditt område på nationell, europeisk och global nivå. Du får samtidigt tillgång till tidig information om utvecklingen inom din bransch. Ta del av det färdiga arbetet Vi erbjuder våra kunder allt som rör standarder och deras tillämpning. Hos oss kan du köpa alla publikationer du behöver allt från enskilda standarder, tekniska rapporter och standardpaket till handböcker och onlinetjänster. Genom vår webbtjänst e-nav får du tillgång till ett lättnavigerat bibliotek där alla standarder som är aktuella för ditt företag finns tillgängliga. Standarder och handböcker är källor till kunskap. Vi säljer dem. Utveckla din kompetens och lyckas bättre i ditt arbete Hos SIS kan du gå öppna eller företagsinterna utbildningar kring innehåll och tillämpning av standarder. Genom vår närhet till den internationella utvecklingen och ISO får du rätt kunskap i rätt tid, direkt från källan. Med vår kunskap om standarders möjligheter hjälper vi våra kunder att skapa verklig nytta och lönsamhet i sina verksamheter. Vill du veta mer om SIS eller hur standarder kan effektivisera din verksamhet är du välkommen in på eller ta kontakt med oss på tel Standards make the world go round SIS (Swedish Standards Institute) is an independent non-profit organisation with members from both the private and public sectors. We are part of the European and global network that draws up international standards. Standards consist of documented knowledge developed by prominent actors within the industry, business world and society. They promote cross-border trade, they help to make processes and products safer and they streamline your organisation. Take part and have influence As a member of SIS you will have the possibility to participate in standardization activities on national, European and global level. The membership in SIS will give you the opportunity to influence future standards and gain access to early stage information about developments within your field. Get to know the finished work We offer our customers everything in connection with standards and their application. You can purchase all the publications you need from us - everything from individual standards, technical reports and standard packages through to manuals and online services. Our web service e-nav gives you access to an easy-to-navigate library where all standards that are relevant to your company are available. Standards and manuals are sources of knowledge. We sell them. Increase understanding and improve perception With SIS you can undergo either shared or in-house training in the content and application of standards. Thanks to our proximity to international development and ISO you receive the right knowledge at the right time, direct from the source. With our knowledge about the potential of standards, we assist our customers in creating tangible benefit and profitability in their organisations. If you want to know more about SIS, or how standards can streamline your organisation, please visit or contact us on phone +46 (0)

3 Europastandarden EN ISO 16954:2015 gäller som svensk standard. Detta dokument innehåller den officiella engelska versionen av EN ISO 16954:2015. The European Standard EN ISO 16954:2015 has the status of a Swedish Standard. This document contains the official English version of EN ISO 16954:2015. Copyright / Upphovsrätten till denna produkt tillhör SIS, Swedish Standards Institute, Stockholm, Sverige. Användningen av denna produkt regleras av slutanvändarlicensen som återfinns i denna produkt, se standardens sista sidor. Copyright SIS, Swedish Standards Institute, Stockholm, Sweden. All rights reserved. The use of this product is governed by the end-user licence for this product. You will find the licence in the end of this document. Upplysningar om sakinnehållet i standarden lämnas av SIS, Swedish Standards Institute, telefon Standarder kan beställas hos SIS Förlag AB som även lämnar allmänna upplysningar om svensk och utländsk standard. Information about the content of the standard is available from the Swedish Standards Institute (SIS), telephone Standards may be ordered from SIS Förlag AB, who can also provide general information about Swedish and foreign standards. Denna standard är framtagen av kommittén för Tandvård, SIS / TK 327. Har du synpunkter på innehållet i den här standarden, vill du delta i ett kommande revideringsarbete eller vara med och ta fram andra standarder inom området? Gå in på - där hittar du mer information.

4

5 EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM Provläsningsexemplar / Preview EN ISO July 2015 ICS English Version Dentistry - Test methods for dental unit waterline biofilm treatment (ISO 16954:2015) Médecine bucco-dentaire - Méthodes d'essais pour le traitement du biofilm dans les conduites d'eau de l'unit dentaire (ISO 16954:2015) Zahnheilkunde - Prüfverfahren zur Biofilmbehandlung der wasserführenden Leitungen einer dentalen Behandlungseinheit (ISO 16954:2015) This European Standard was approved by CEN on 23 April 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 obtained 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 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, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 16954:2015 E

6 SS-EN ISO 16954:2015 (E) Provläsningsexemplar / Preview Contents Page Foreword...iv 1 Scope Normative references Terms and definitions Treatment methods Test water and bacterial challenge suspensions Test water Reagents Preparation of hardness stock solution Preparation of hardness stock solution Preparation of test water prior to inoculation Bacterial challenge Inoculated test water Test apparatus Test apparatus design General Considerations specific to antimicrobial materials and materials which prevent microbial adhesion Test apparatus operation Flow rates Flow patterns (on-off cycles) Test environment temperature and preconditioning period Test procedures Testing sequence Biofilm prevention or inhibition General Pretreatment of the test apparatuses Concurrent exposure to inoculated test water and the treatment method for biofilm prevention or inhibition Microbiological sampling and testing Test duration Analysis of results Biofilm removal General Initial microbiological sampling and testing Application of the biofilm removal treatment method Final microbiological sampling and testing Analysis of results Microbiological sampling and testing Enumeration of bacteria levels in procedural water Sampling Total viable count test procedure Alternative total viable count test procedure Biofilm on waterline surfaces Sampling Biofilm assessment test procedure Test Report...13 Bibliography...14 iii

7 SS-EN ISO 16954:2015 (E) European 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 publication 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 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 Regulations, 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, 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. iv

8

9 SS-EN ISO 16954:2015 (E) Dentistry Test methods for dental unit waterline biofilm treatment 1 Scope This 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 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 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 potentially 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 references The 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 undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1942, Dentistry Vocabulary ISO 3696:1987, Water for analytical laboratory use Specification and test methods ISO , Dentistry Dental units Part 1: General requirements and test methods ISO , Dentistry Dental units Part 2: Water and air supply ISO 10523, Water quality Determination of ph ISO 19458, Water quality Sampling for microbiological analysis IEC , Medical electrical equipment Part 1: General requirements for basic safety and essential performance 3 Terms and definitions For the purposes of this document, the terms and definitions given in IEC , ISO 1942, ISO , and ISO and the following apply. 3.1 biofilm structured community of microorganisms inhabiting a self-developed extracellular biopolymeric matrix attached to a surface 1

10 SS-EN ISO 16954:2015 (E) Provläsningsexemplar / Preview 3.2 dental unit combination of interconnected dental equipment and dental instruments constituting a functional assembly for use in the provision of dental treatment [SOURCE: ISO 1942:2009, 2.86] 3.3 dental unit procedural water delivery system system of components of a dental unit which convey water from a supply source to one or more outlets used for dental treatment 3.4 procedural water water supplied by the dental unit for use in the oral cavity EXAMPLE water. Handpiece procedural water, multifunctional syringe water, scaler procedural water, or rinse cup [SOURCE: ISO :2003, 3.1] 3.5 surrogate dental unit water system test 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 necessarily including other dental unit components which do not directly come in contact with or control the flow of procedural water 3.6 test water water having specified chemical and physical characteristics used for testing prior to the addition of the specified bacterial challenge suspension 3.7 bacterial challenge suspension consortium of specified bacteria suspended in a nutrient growth medium or buffered solution used to inoculate test water 3.8 inoculated test water prepared aqueous suspension used in testing, containing specified amounts of sterilized test water and one or more bacterial challenge suspension(s) 3.9 test apparatus for the control group apparatus used in testing in which no treatment method is applied and no antimicrobial material is present in the waterline components 3.10 test apparatus for the test group apparatus 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 requirements 2

11 SS-EN ISO 16954:2015 (E) 4 Treatment methods Depending 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 formation 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 expanded 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 suspensions 5.1 Test water This subclause specifies the preparation of test water prior to inoculation Reagents Water, in accordance with ISO 3696:1987, grade Calcium chloride (CaCl 2 ), or an equivalent molar quantity of a calcium chloride hydrate Magnesium chloride (MgCl 2 ), or an equivalent molar quantity of a magnesium chloride hydrate Sodium bicarbonate (NaHCO 3 ) Tryptic soy broth (TSB), 1/3-strength, 10,0 g tryptic soy medium per litre broth Sodium hydroxide (NaOH), 1 mol/l Hydrochloric acid (HCl), 1 mol/l Preparation of hardness stock solution 1 Dissolve 74,0 g of calcium chloride ( ) and 31,7 g of magnesium chloride ( ) in 1,00 l water ( ). Hardness stock solution 1 shall be sterilized by heat or filter-sterilized using a 0,2 μm microfilter and used within 24 h or stored at (5 ± 3) C for up to 6 months Preparation of hardness stock solution 2 Dissolve 56,0 g of sodium bicarbonate ( ) in 1,00 l water ( ). Hardness stock solution 2 shall be filter-sterilized using 0,2 μm 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 Preparation of test water prior to inoculation For each litre of test water to be prepared, add 1,00 ml of 1/3-strength TSB ( ) and 1,80 ml of hardness stock solution 1 (5.1.2) to 1,00 l water ( ) 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- 3