1、DD ISO/TS11080:2009ICS 11.060.20NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWDRAFT FOR DEVELOPMENTDentistry Essentialcharacteristics oftest methods forthe evaluation oftreatment methodsintended to improveor maintain themicrobiologicalquality of dental unitprocedural waterThi
2、s Draft for Developmentwas published underthe authority of theStandards Policy andStrategy Committee on 30November 2009 BSI 2009ISBN 978 0 580 62945 7Amendments/corrigenda issued since publicationDate CommentsDD ISO/TS 11080:2009National forewordThis Draft for Development is the UK implementation of
3、 ISO/TS11080:2009.This publication is not to be regarded as a British Standard.It is being issued in the Draft for Development series of publications andis of a provisional nature. It should be applied on this provisional basis,so that information and experience of its practical application can beob
4、tained.Comments arising from the use of this Draft for Development arerequested so that UK experience can be reported to the internationalorganization responsible for its conversion to an international standard.A review of this publication will be initiated not later than 3 years afterits publicatio
5、n by the international organization so that a decision can betaken on its status. Notification of the start of the review period will bemade in an announcement in the appropriate issue of Update Standards.According to the replies received by the end of the review period,the responsible BSI Committee
6、 will decide whether to support theconversion into an international Standard, to extend the life of theTechnical Specification or to withdraw it. Comments should be sent tothe Secretary of the responsible BSI Technical Committee at BritishStandards House, 389 Chiswick High Road, London W4 4AL.The UK
7、 participation in its preparation was entrusted to TechnicalCommittee CH/106/4, Dental Instruments and Equipment.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Us
8、ers are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.DD ISO/TS 11080:2009Reference numberISO/TS 11080:2009(E)ISO 2009TECHNICAL SPECIFICATION ISO/TS11080First edition2009-06-01Dentistry Essential characteristics of test method
9、s for the evaluation of treatment methods intended to improve or maintain the microbiological quality of dental unit procedural water Art dentaire Caractristiques essentielles des mthodes dessai pour lvaluation des mthodes de traitement pour amliorer ou maintenir la qualit microbiologique de leau pr
10、ocdurale de lunit dentaire DD ISO/TS 11080:2009ISO/TS 11080:2009(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installe
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13、se inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2009 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm,
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15、 rights reservedDD ISO/TS 11080:2009ISO/TS 11080:2009(E) ISO 2009 All rights reserved iiiContents Page Foreword iv 1 Scope 1 2 Normative references1 3 Terms and definitions .1 4 Dental unit water treatment methods 2 5 Test methods .2 5.1 General .2 5.2 Test methods for evaluating biofilm removal.3 5
16、.3 Test methods for evaluating biofilm prevention or inhibition 4 6 Test apparatus design and operation .5 6.1 Test apparatus design 5 6.2 Test apparatus operation5 7 Microbiological challenge.5 7.1 Microbiological consortium5 7.2 Microbiological characteristics5 8 Chemical characteristics of water
17、used for testing .6 8.1 Water type 6 8.2 Water characteristics 7 9 Microbiological sampling and testing .7 9.1 Sampling.7 9.2 Testing7 9.3 Corroborative testing 7 9.4 Measures for residual antimicrobial agents .8 10 Test report8 Bibliography9 DD ISO/TS 11080:2009ISO/TS 11080:2009(E) iv ISO 2009 All
18、rights reservedForeword ISO (the International Organization for Standardization) 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 subjec
19、t for which a technical committee has been established has the right to 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)
20、 on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules 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 committee
21、s are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. In other circumstances, particularly when there is an urgent market requirement for such documents, a technical committee may decide to p
22、ublish other types of normative document: an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in an ISO working group and is accepted for publication if it is approved by more than 50 % of the members of the parent committee casting a vote; an ISO Tech
23、nical Specification (ISO/TS) represents an agreement between the members of a technical committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting a vote. An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirme
24、d for a further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an International Standard or be withdrawn. Attention is drawn to the possi
25、bility 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/TS 11080 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental equipment. DD ISO/TS 11080:2009TEC
26、HNICAL SPECIFICATION ISO/TS 11080:2009(E) ISO 2009 All rights reserved 1Dentistry Essential characteristics of test methods for the evaluation of treatment methods intended to improve or maintain the microbiological quality of dental unit procedural water 1 Scope This Technical Specification provide
27、s guidelines for type test methods for evaluating the effectiveness of treatment methods intended to improve or maintain the microbiological quality of procedural water from dental units and other dental equipment under laboratory conditions. It does not establish specific upper limits for microbial
28、 contamination or describe test methods to be used in clinical situations. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referen
29、ced document (including any amendments) applies. ISO 1942, Dentistry Vocabulary ISO 7494-1, Dentistry Dental units Part 1: General requirements and test methods ISO 7494-2, Dentistry Dental units Part 2: Water and air supply ISO 19458, Water quality Sampling for microbiological analysis IEC 60601-1,
30、 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 60601-1, ISO 1942, ISO 7494-1 and ISO 7494-2 and the following apply. Two of the terms taken from ot
31、her documents are reproduced below for convenience and the sake of clarity. 3.1 biofilm structured community of microorganisms inhabiting a self-developed extracellular biopolymeric matrix attached to a surface DD ISO/TS 11080:2009ISO/TS 11080:2009(E) 2 ISO 2009 All rights reserved3.2 dental unit co
32、mbination of interconnected dental equipment and dental instruments constituting a functional assembly for use in the provision of dental treatment ISO 1942:, definition 2.86 3.3 procedural water water supplied by the dental unit for use in the oral cavity EXAMPLE Handpiece coolant water, syringe wa
33、ter, scaler coolant water or rinse cup water. ISO 7494-2:2003, definition 3.1 4 Dental unit water treatment methods Technical approaches for improving or maintaining the microbiological quality of dental unit procedural water, which are currently available, include, but need not be limited to: denta
34、l units with automatic or passive water treatment devices and/or antimicrobial materials; independent water bottles with intermittent or continuous chemical treatment. The test method used to evaluate a treatment method shall be specified with consideration for the technical approach of the method.
35、Depending upon the specific technical approach of a treatment method and its intended benefits, the test method shall evaluate one or both of the following aspects: removal of biofilm from surfaces within the dental unit water delivery system; prevention or inhibition of biofilm formation on surface
36、s within the dental unit water delivery system. Separate test method characteristics are specified in Clause 5 for each of the above performance metrics. 5 Test methods 5.1 General Test methods shall replicate the conditions of use and the technical approach specified by the manufacturer of the dent
37、al unit or waterline treatment product. The test apparatus should preferably consist of dental units. As an alternative, surrogate systems, which closely replicate the dental unit water system, may be used as the test apparatus. Test apparatus design and operation characteristics are specified in Cl
38、ause 6. Initial validation testing shall be performed under controlled laboratory conditions and not in clinical settings. Test methods shall include untreated controls. Since there is inherent variation in biofilm formation, testing should be replicated on separate dental units or surrogate waterli
39、ne systems. Test methods shall specify the number of test replicates to be included in the test group and control group. At least two units shall be included in the test group and at least one unit shall be included in the control group. DD ISO/TS 11080:2009ISO/TS 11080:2009(E) ISO 2009 All rights r
40、eserved 35.2 Test methods for evaluating biofilm removal 5.2.1 General Test methods for evaluating treatment methods that are intended to remove dental waterline biofilms shall include the following steps. 5.2.2 Biofilm formation and characterization A biofilm shall be established in the test appara
41、tus in a manner consistent with biofilms occurring in typical clinical situations. The method for establishing a biofilm in the test apparatus shall be able to be replicated by independent evaluators. The preferred method for generating a biofilm in the test apparatus consists of conditioning the te
42、st apparatus by flowing a microbiological challenge suspension through the test apparatus for a period sufficient to establish a reproducible biofilm. Test apparatus design and operation characteristics are specified in Clause 6. Microbiological challenge characteristics are specified in 7.1 and 7.2
43、.2. Chemical characteristics of the water used in the biofilm formation shall be consistent with the specifications in Clause 8. The presence of an established biofilm shall be verified using the methods specified in Clause 9. Colony counts in the effluent water from the test apparatus should be con
44、sistent with those found in typical clinical situations: 104CFU/ml to 106CFU/ml. 5.2.3 Application of the treatment method The treatment method for removal of the established biofilm shall be administered in accordance with the instructions of the manufacturer of the dental unit or waterline treatme
45、nt product (except for the untreated control group). Chemical characteristics of the water used in the application of the treatment method shall be consistent with the specifications in Clause 8. 5.2.4 Microbiological sampling and testing To determine the effectiveness of the treatment method, micro
46、biological sampling and testing of both the treated and untreated controls shall be performed in accordance with Clause 9. Consideration shall be given to specify the most appropriate time to sample after administering the treatment. If flushing with procedural water or another solution is specified
47、 by the manufacturer, this shall be performed before sampling and testing. 5.2.5 Analysis of results The effectiveness of the treatment method to remove biofilm shall be evaluated against criteria defined prior to testing. The criteria should include at least specifications for a maximum allowable l
48、evel of bacteria counts in the effluent water from the treated test group and a minimum level of bacteria counts in the effluent water of the control group. Preferably, criteria which more directly indicate whether biofilm has been removed should also be specified. DD ISO/TS 11080:2009ISO/TS 11080:2
49、009(E) 4 ISO 2009 All rights reserved5.3 Test methods for evaluating biofilm prevention or inhibition 5.3.1 General Test methods for evaluating treatment methods that are intended to inhibit or prevent biofilm formation shall include the following steps. Test apparatus design and operation characteristics are specified in Clause 6. 5.3.2 Pretreatment of the test apparatus The test apparatus shall be pretreated according to the instructions of the manufacturer of the dental unit or waterline treatment produc
