DIN EN ISO 6874-2015 Dentistry - Polymer-based pit and fissure sealants (ISO 6874 2015) German version EN ISO 6874 2015《牙科学 树脂基窝沟和裂纹封闭剂(ISO 6874-2015) 德文版本EN ISO 6874-2015》.pdf

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1、December 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 11.060.10!%J“2399688www.din.deD

2、IN EN ISO 6874Dentistry Polymer-based pit and fissure sealants (ISO 6874:2015);English version EN ISO 6874:2015,English translation of DIN EN ISO 6874:2015-12Zahnheilkunde Versiegelungskunststoffe fr Grbchen und Fissuren (ISO 6874:2015);Englische Fassung EN ISO 6874:2015,Englische bersetzung von DIN

3、 EN ISO 6874:2015-12Mdecine bucco-dentaire Produits dentaires base de polymres pour comblement des puits et fissures (ISO 6874:2015);Version anglaise EN ISO 6874:2015,Traduction anglaise de DIN EN ISO 6874:2015-12SupersedesDIN EN ISO 6874:2005-12www.beuth.deDocument comprises 16 pagesDTranslation by

4、 DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.01.16DIN EN ISO 6874:2015-12 2 A comma is used as the decimal marker. National foreword This document (EN ISO 6874:2015) has been prepared by Technical Committee CEN/TC 55 “Dentistry” (Secretariat: D

5、IN, Germany) in collaboration with Technical Committee ISO/TC 106 “Dentistry”. The responsible German body involved in its preparation was DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Working Committee NA 014-00-01 AA Fllungswerkstoffe. The DIN Standards corresponding to the Inter

6、national Standards referred to in Clause 2 of this standard are as follows: ISO 1942 DIN EN ISO 1942 ISO 8601 DIN ISO 8601 Amendments This standard differs from DIN EN ISO 6874:2005-12 as follows: a) ISO 1942 has been added to the normative references; b) the temperature range for testing specified

7、in 6.2 has been extended from (23 1) C to (23 2) C; c) marking of the capsule or single dose container shall now also include the expiry date; d) the manufacturers instructions shall now also include a description of the shade or shades of the material. Previous editions DIN EN ISO 6874: 2005-12 DIN

8、 EN 26874: 1992-10 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Vocabulary DIN ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 6874 September 2015 ICS 11.060.

9、10 Supersedes EN ISO 6874:2005English Version Dentistry - Polymer-based pit and fissure sealants Mdecine bucco-dentaire - Produits dentaires base de polymres pour comblement des puits et fissures Zahnheilkunde - Versiegelungskunststoffe fr Grbchen und Fissuren (ISO 6874:2015) This European Standard

10、was approved by CEN on 10 July 2015. 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 na

11、tional 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 lan

12、guage 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, Greec

13、e, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, 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 CE

14、N-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 6874:2015 E(ISO 6874:2015) (ISO 6874:2015) Foreword .Introduction 1 Scope .2 Normative references 3 Classificat

15、ion 4 Requirements 4.1 Biocompatibility 4.2 Physical properties 4.2.1 Working time, Class 1 sealant .4.2.2 Setting time, Class 1 sealant .4.2.3 Depth of cure, Class 2 sealant .5 Sampling 6 Test methods .6.1 Inspection 6.2 Test conditions 6.3 Preparation of test specimens .6.4 Working time, Class 1 s

16、ealant 6.4.1 Apparatus .6.4.2 Procedure .6.4.3 Treatment of results.6.5 Setting time, Class 1 sealant .6.5.1 Apparatus 6.5.2 Procedure 6.5.3 Treatment of results.6.6 Depth of cure, Class 2 sealant 6.6.1 Apparatus 6.6.2 Procedure 6.6.3 Treatment of results.7 Packaging, marking and instructions and in

17、formation to be supplied by the manufacturer 7.1 Packaging 7.2 Marking 7.2.1 Capsule or single dose container 7.2.2 Outer pack 7.3 Manufacturers instructions and information for the user Bibliography .Contents PageEuropean foreword. . 3 2EN ISO 6874:2015 (E) 45666666666777777791010101011111111111212

18、12121214DIN EN ISO 6874:2015-12 10European foreword This document (EN ISO 6874:2015) has been prepared by Technical Committee ISO/TC 106in 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 natio

19、nal standard, either by publication of an identical text or by endorsement, at the latest by March 2016, and conflicting national standards shall be 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 of patent ri

20、ghts. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 6874:2005. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Sta

21、ndard: 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, S

22、pain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 6874:2015 has been approved by CEN as EN ISO 6874:2015 without any modification. “Dentistry”EN ISO 6874:2015 (E) 3DIN EN ISO 6874:2015-12 ForewordISO (the International Organization for Standardization) is a

23、 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 to be represente

24、d 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 used to develop th

25、is 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 of the ISO/IEC D

26、irectives, 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 identified during the dev

27、elopment 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 the meaning of ISO

28、 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/TC 106, Dentistry

29、, Subcommittee SC1, Filling and restorative materials.This third edition cancels and replaces the second edition (ISO 6874:2005), of which it constitutes a minor revision.EN ISO 6874:2015 (E) 4DIN EN ISO 6874:2015-12 IntroductionThe efficacy of pit and fissure sealants for the prevention of dental c

30、aries is widely accepted. The polymer-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 re

31、quirements for freedom from biological 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.EN ISO 6874:2015 (E) 5DIN EN ISO 6874:2015-12 1 ScopeThis International Standard specifies requir

32、ements 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, are normatively referenced in this docum

33、ent 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 and interchange formats Information inte

34、rchange 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 mixing an initiator and activator (“self-curi

35、ng” 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 biocompatibility, ISO 7405 and ISO 10993-1.4.2 Physic

36、al 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, shall not be greater than 5 min.4.2.3 Dep

37、th 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.EN ISO 6874:2015 (E) 6DIN EN ISO 6874:2015-12 5 SamplingThe test samp

38、le 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 methods6.1 InspectionInspect visually to check that requirements specified in Clause 7 have been met.6.2 Te

39、st 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 material was refrigerated for storage, allow it to attain (23 2) C before use.For the preparation of

40、 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 be taken to ensure that the source is in a satisfactory operating condition.NOTE See also ISO 10650

41、(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 sealant6.4.1 Apparatus6.4.1.1 Thermometry apparatus, as shown in Figure 1.of polyamide or similar ma

42、terial, B, which has a hole into which is inserted a stainless steel tube, C, containing a stabilized 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 t

43、wo components form a specimen well 4 mm high 4 mm in diameter. In order to facilitate removal of the 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 consi

44、sts of wires (0,25 0,05) mm in diameter, made of a material (e.g. copper/constantan) capable of registering 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

45、temperature to that accuracy.NOTE A prefabricated thermocouple of similar size and performance can be substituted.EN ISO 6874:2015 (E) 7The apparatus consists of a piece of polyethylene (or similar material) tubing, AN1), located on a block N1)National footnote: In the key to Figure 1, items A, B, C

46、, and D are referred to as 1, 2, 3, and 4. DIN EN ISO 6874:2015-12 Key1 polyethylene tubing2 polyamide block3 stainless steel tube4 thermocouple5 silver solderingFigure 1 Apparatus for determination of working and setting timesEN ISO 6874:2015 (E) 8DIN EN ISO 6874:2015-12 6.4.2 ProcedurePrepare the

47、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 sealant. Maintain the apparatus at (23

48、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 begins to increase denotes the start of the setting reaction and, therefore, the e

49、nd of the working time. The results are extremely temperature dependent and slight variations within the permitted temperature range will cause variations of 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 insertion to the start of the setting reaction at T1, denoted as t