EN ISO 6874-2015 en Dentistry - Polymer-based pit and fissure sealants《牙科 聚合物凹陷和齿面裂沟封剂(ISO 6874 2015)》.pdf

1、BSI Standards PublicationBS EN ISO 6874:2015Dentistry Polymer-based pitand fissure sealantsBS EN ISO 6874:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 6874:2015.It supersedes BS EN ISO 6874:2005 which is withdrawn.The UK participation in its preparat

2、ion was entrusted to Technical Committee CH/106/1, Dental restorative and orthodontic materials.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are respons

3、ible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 88297 5 ICS 11.060.10 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standar

4、ds Policy and Strategy Committee on 30 September 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 6874 September 2015 ICS 11.060.10 Supersedes EN ISO 6874:2005English Version Dentistry - Polymer-based pit and fiss

5、ure sealants (ISO 6874:2015) Mdecine bucco-dentaire - Produits dentaires base de polymres pour comblement des puits et fissures (ISO 6874:2015) Zahnheilkunde - Versiegelungskunststoffe fr Grbchen und Fissuren (ISO 6874:2015) This European Standard was approved by CEN on 10 July 2015. CEN members are

6、 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 t

7、he 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 Cen

8、tre 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, Lithuan

9、ia, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-100

10、0 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 6874:2015 EBS EN ISO 6874:2015EN ISO 6874:2015 (E) 3 European foreword This document (EN ISO 6874:2015) has been prepared by Technical Committee ISO/TC 106 “Dentis

11、try“in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held byDIN. This European Standard shall be given the status of a national standard, either by publication of anidentical text or by endorsement, at the latest by March 2016, and conflicting national stan

12、dards shallbe withdrawn at the latest by March 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject ofpatent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patentrights. This document supersedes EN ISO 687

13、4:2005. According to the CEN-CENELEC Internal Regulations, the national standards organizations of thefollowing countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,France

14、, 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 6874:2015 has been approved by CEN as EN ISO 6874

15、:2015 without any modification. BS EN ISO 6874:2015ISO 6874:2015(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Classification 14 Requirements 14.1 Biocompatibility 14.2 Physical properties 14.2.1 Working time, Class 1 sealant . 14.2.2 Setting time, Class 1 sealant . 14.2.3 Depth of

16、 cure, Class 2 sealant . 15 Sampling 26 Test methods . 26.1 Inspection 26.2 Test conditions 26.3 Preparation of test specimens . 26.4 Working time, Class 1 sealant 26.4.1 Apparatus . 26.4.2 Procedure . 46.4.3 Treatment of results 46.5 Setting time, Class 1 sealant 56.5.1 Apparatus . 56.5.2 Procedure

17、 . 56.5.3 Treatment of results 56.6 Depth of cure, Class 2 sealant . 66.6.1 Apparatus . 66.6.2 Procedure . 66.6.3 Treatment of results 67 Packaging, marking and instructions and information to be supplied by the manufacturer . 67.1 Packaging . 77.2 Marking . 77.2.1 Capsule or single dose container .

18、 77.2.2 Outer pack . 77.3 Manufacturers instructions and information for the user . 7Bibliography 9 ISO 2015 All rights reserved iiiContents PageBS EN ISO 6874:2015ISO 6874:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies

19、(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. International organizations, g

20、overnmental 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 used to develop this document and those intended for its further main

21、tenance 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 of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Atte

22、ntion 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 identified during the development of the document will be in the Introductio

23、n 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 the meaning of ISO specific terms and expressions related to conformi

24、ty 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/TC 106, Dentistry, Subcommittee SC1, Filling and restorative materia

25、ls.This third edition cancels and replaces the second edition (ISO 6874:2005), of which it constitutes a minor revision.iv ISO 2015 All rights reservedBS EN ISO 6874:2015ISO 6874:2015(E)IntroductionThe efficacy of pit and fissure sealants for the prevention of dental caries is widely accepted. The p

26、olymer-based materials intended for this purpose and covered by this International Standard harden by a free-radical polymerisation reaction that is either initiated by mixing components or by external energy, e.g. visible light.Specific qualitative and quantitative requirements for freedom from bio

27、logical hazard are not included in this International Standard but, when assessing possible biological hazards, reference can be made to ISO 10993 (all parts) and ISO 7405. ISO 2015 All rights reserved vBS EN ISO 6874:2015BS EN ISO 6874:2015Dentistry Polymer-based pit and fissure sealants1 ScopeThis

28、 International Standard specifies requirements and test methods for polymer-based materials intended for sealing pits and fissures in teeth.This International Standard covers both self-curing and external-energy-activated materials.2 Normative referencesThe following documents, in whole or in part,

29、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 VocabularyISO 8601, Data elements

30、and interchange formats Information interchange Representation of dates and times3 ClassificationFor the purposes of this International Standard, polymer-based pit and fissure sealants are classified, according to the method of curing, as follows:Class 1: Materials whose setting is effected by mixin

31、g an initiator and activator (“self-curing” materials).Class 2: Materials whose setting is effected by the application of energy from an external source, such as visible light (“external-energy-activated” materials).4 Requirements4.1 BiocompatibilitySee the Introduction for guidance on biocompatibil

32、ity, ISO 7405 and ISO 10993-1.4.2 Physical properties4.2.1 Working time, Class 1 sealantThe working time for Class 1 sealants, determined in accordance with 6.4, shall not be less than 40 s.4.2.2 Setting time, Class 1 sealantThe setting time for Class 1 sealants, determined in accordance with 6.5, s

33、hall not be greater than 5 min.4.2.3 Depth of cure, Class 2 sealantThe depth of cure for Class 2 sealants, determined in accordance with 6.6, shall be not less than 1,5 mm. If the material is supplied in more than one shade, each shade shall comply with this requirement.INTERNATIONAL STANDARD ISO 68

34、74:2015(E) ISO 2015 All rights reserved 1BS EN ISO 6874:2015ISO 6874:2015(E)5 SamplingThe test sample shall consist of a retail package, or packages, from the same batch containing sufficient material (a minimum of 20 g) to carry out the specified tests and repeat tests, if necessary.6 Test methods6

35、.1 InspectionInspect visually to check that requirements specified in Clause 7 have been met.6.2 Test conditionsUnless specified otherwise by the manufacturer, prepare and test all specimens at (23 2) C. Control the relative humidity to ensure that it remains greater than 30 % at all times. If the m

36、aterial was refrigerated for storage, allow it to attain (23 2) C before use.For the preparation of class 2 materials, reference shall be made to the manufacturers instructions see 7.3 e) and g) that state the external energy source or sources recommended for the materials to be tested. Care shall b

37、e taken to ensure that the source is in a satisfactory operating condition.NOTE See also ISO 10650 (all parts).6.3 Preparation of test specimensMix or otherwise prepare the material in accordance with the manufacturers instructions and the test conditions specified in 6.2.6.4 Working time, Class 1 s

38、ealant6.4.1 Apparatus6.4.1.1 Thermometry apparatus, as shown in Figure 1.The apparatus consists of a piece of polyethylene (or similar material) tubing, A, located on a block of polyamide or similar material, B, which has a hole into which is inserted a stainless steel tube, C, containing a stabiliz

39、ed thermocouple D.The polyethylene tube A is 6 mm long, 4 mm in internal diameter and has a wall thickness of 1 mm. The locating part of block B is 4 mm in diameter and 2 mm high. When assembled, the two components form a specimen well 4 mm high 4 mm in diameter. In order to facilitate removal of th

40、e specimen after testing, the thermocouple D has a conical tip that protrudes 1 mm into the base of the specimen well. The tolerances on the above-mentioned dimensions are 0,1 mm.The thermocouple consists of wires (0,25 0,05) mm in diameter, made of a material (e.g. copper/constantan) capable of reg

41、istering rapid temperature changes in a specimen of setting material to an accuracy of 0,1 C. The thermocouple is connected to an instrument (e.g. voltmeter or chart recorder) capable of recording the temperature to that accuracy.NOTE A prefabricated thermocouple of similar size and performance can

42、be substituted.2 ISO 2015 All rights reservedBS EN ISO 6874:2015ISO 6874:2015(E)Key1 polyethylene tubing2 polyamide block3 stainless steel tube4 thermocouple5 silver solderingFigure 1 Apparatus for determination of working and setting times ISO 2015 All rights reserved 3BS EN ISO 6874:2015ISO 6874:2

43、015(E)6.4.2 ProcedurePrepare the sealant in accordance with the manufacturers instructions (see 7.3) and start timing from the moment mixing is begun. Maintain the mould at (23 1) C. At 30 s after the start of mixing, place the mixed sealant in the mould and record the temperature, T1, of the sealan

44、t. Maintain the apparatus at (23 1) C and continuously record the temperature of the sealant until the peak temperature is reached.NOTE A typical recording trace is shown in Figure 2. As soon as the sealant is inserted into the mould, the temperature can fall slightly until it becomes steady at T0an

45、d then starts to increase. The point at which the temperature begins to increase denotes the start of the setting reaction and, therefore, the end of the working time. The results are extremely temperature dependent and slight variations within the permitted temperature range will cause variations o

46、f several seconds.Record the time, tw,from the start of mixing until the temperature starts to increase.Carry out five determinations.KeyX time, in secondsY temperatureT0temperature at time of insertionT1temperature after a slight drop immediately after time of insertionT2peak temperaturetwtime of i

47、nsertion to the start of the setting reaction at T1, denoted as the working timetstime of insertion to the time of the peak temperature, denoted as the setting timeFigure 2 Typical recording trace showing temperature changes in time for determination of working and setting times6.4.3 Treatment of re

48、sultsRecord the working times and report as follows:a) if at least four of the times obtained are equal to or longer than 40 s, the material is deemed to have complied with the requirement of 4.2.1;4 ISO 2015 All rights reservedBS EN ISO 6874:2015ISO 6874:2015(E)b) if three or more of the times are

49、shorter than 40 s, the material is deemed to have failed;c) if only three of the times are equal to or longer than 40 s, repeat the whole test. All the specimens in the second series shall comply with the requirement otherwise the material is deemed to have failed the whole test.6.5 Setting time, Class 1 sealant6.5.1 Apparatus6.5.1.1 Thermometry apparatus, as specified in 6.4.1.1.6.5.2 ProcedureRepeat the procedure described in 6.4.2, but maintain the apparatus at (37 1) C in air.Record the time elapsed between