EN ISO 6876-2012 en Dentistry - Root canal sealing materials《牙医学 牙根管充填材料》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 6876:2012Dentistry Root canal sealingmaterials (ISO 6876:2012)BS EN ISO 6876:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN

2、ISO 6876:2012.It supersedes BS EN ISO 6876:2002 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/1, Dental restorative and orthodontic materials.A list of organizations represented on this committee can beobtained on request to its secretary.This

3、publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2012. Published by BSI StandardsLimited 2012ISBN 978 0 580 59578 3ICS 11.060.10Compliance with a British Standard cannot confer immun

4、ity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 July 2012.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 6876 July 2012 ICS 11.060.10 Supersedes EN ISO

5、 6876:2002English Version Dentistry - Root canal sealing materials (ISO 6876:2012) Mdecine bucco-dentaire - Matriaux de scellement des canaux radiculaires (ISO 6876:2012) Zahnheilkunde - Wurzelkanalfllpaste (ISO 6876:2012) This European Standard was approved by CEN on 16 June 2012. CEN members are b

6、ound 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

7、 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 Centr

8、e 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

9、, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 20

10、12 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 6876:2012: EBS EN ISO 6876:2012EN ISO 6876:2012 (E) 3 Foreword This document (EN ISO 6876:2012) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration

11、 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 2013, and conflicting national standards shall be w

12、ithdrawn at the latest by January 2013. 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. This document supersedes EN ISO 6876:2002. Acc

13、ording 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, German

14、y, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, the United Kingdom and Turkey. Endorsement notice The text of ISO 6876:2012 has been approved by CEN as a EN ISO 6876:201

15、2 without any modification. BS EN ISO 6876:2012ISO 6876:2012(E)ForewordISO (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 comm

16、ittees. 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, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the

17、International Electrotechnical Commission (IEC) 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

18、 Standards adopted by the technical committees 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.Attention is drawn to the possibility that some of the elements of this document may be the s

19、ubject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 6876 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and restorative materials.This third edition cancels and replaces the second edition (ISO 6876:2001)

20、, which has been technically revised. The main modifications are the following: the test procedures for flow, working time and solubility have been revised and a new limit value has been set; the test to determine dimensional change following setting has been removed. ISO 2012 All rights reserved ii

21、iBS EN ISO 6876:2012ISO 6876:2012(E)IntroductionFollowing the publication of the second edition of this International Standard (ISO 6876:2001), test houses reported difficulties with some of the test procedures. In an attempt to improve the test procedures, a planned programme of revision began in 2

22、006. The following should be taken into account when using this International Standard. Verification for a claim of sterility is the responsibility of the manufacturer. This International Standard does not specify requirements or test methods for sterility and it is recommended that reference be mad

23、e to any national requirements that may exist. When no national requirements exist, reference should be made to the United States, European or Japanese Pharmacopoeia. If a therapeutic effect is claimed, the purity and sterility of the constituents are expected to comply with the relevant pharmacopoe

24、ia applicable in the country in which the sealer is marketed, or with such national regulations as are applicable to purity and sterility of pharmaceutical products. Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological risks are not included in th

25、is International Standard but it is recommended that, for the assessment of such biological risks, reference be made to ISO 10993-1 and ISO 7405.iv ISO 2012 All rights reservedBS EN ISO 6876:2012Dentistry Root canal sealing materials1 ScopeThis International Standard specifies requirements and test

26、methods for root canal (endodontic) sealing materials which set with or without the assistance of moisture and are used for permanent obturation of the root canal with or without the aid of obturating points/cones. It only covers sealers intended for orthograde use i.e. a root filling placed from th

27、e coronal aspect of a tooth.Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological risks are not included in this International Standard but it is recommended that, for the assessment of such biological risks, reference be made to ISO 10993-1 and IS

28、O 7405.2 Normative referencesThe 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 referenced document (including any amendments) applies.ISO 1942, Dentistry V

29、ocabularyISO 3665, Photography Intra-oral dental radiographic film and film packets Manufacturer specificationsISO 3696, Water for analytical laboratory use Specification and test methodsISO 6873, Dentistry Gypsum productsISO 8601, Data elements and interchange formats Information interchange Repres

30、entation of dates and times3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.3.1root canal sealing materialendodontic material intended to permanently seal the root canal filling material into the cavities previously occupie

31、d by the removed pulp3.2root canal filling materialendodontic material intended to permanently obturate the cavities previously occupied by the pulp3.3mixing timethat part of the working time required in order to obtain a satisfactory mix of the components3.4working timeperiod of time, measured from

32、 the start of mixing, during which it is possible to manipulate the root canal sealer without any adverse effect on its propertiesINTERNATIONAL STANDARD ISO 6876:2012(E) ISO 2012 All rights reserved 1BS EN ISO 6876:2012ISO 6876:2012(E)3.5setting timeperiod of time measured from the end of mixing unt

33、il the sealer has set, according to the criteria and conditions described in 5.4NOTE For the purposes of this International Standard, the setting time is determined from the end of mixing because of the wide variation in mixing times.4 Requirements4.1 ComponentsThe components of the sealer shall be

34、free from extraneous matter when tested according to 5.1.The components shall, when used in accordance with the manufacturers instructions, form a sealer which complies with the requirements of this International Standard.4.2 Microbiological hazardSpecific qualitative and quantitative requirements f

35、or the determination of microbiological growth are not included in this International Standard.4.3 Physical and mechanical properties4.3.1 FlowWhen determined in accordance with 5.2, each disc shall have a diameter of not less than 17 mm.4.3.2 Working timeFor sealers that are claimed by the manufact

36、urer to have a stated working time of up to 30 min, the diameter of the flow test, determined in accordance with 5.2, shall be not less than 17 mm 15 s before the end of the stated working time.4.3.3 Setting timeFor sealers that are claimed by the manufacturer to have a setting time of up to 30 min,

37、 the setting time shall be no more than 10 % longer than that claimed by the manufacturer, when determined in accordance with 5.4.For sealers that are claimed by the manufacturer to have a setting time of more than 30 min and up to 72 h, and for which the manufacturer quotes a time range, the settin

38、g time measured shall be within the range stated by the manufacturer, when determined in accordance with 5.4.4.3.4 Film thicknessSealers shall have a film thickness of not more than 50 m when tested in accordance with 5.5.4.3.5 Solubility and disintegrationThe solubility of the set sealer, when dete

39、rmined in accordance with 5.6, shall not exceed 3,0 % by mass.The specimen shall show no evidence of disintegration when examined visually.4.3.6 Radio-opacityThe sealer, when tested in accordance with 5.7, shall have a radio-opacity equivalent to not less than 3 mm of aluminium.2 ISO 2012 All rights

40、 reservedBS EN ISO 6876:2012ISO 6876:2012(E)4.4 SamplingUse one or more retail packages from the same batch, containing sufficient sealer to carry out the specified tests, plus an allowance for repeats, if necessary.4.5 Test conditionsUnless otherwise stated by the manufacturer, carry out all tests

41、at (23 2) C and at (50 5) % RH. Condition all components at this temperature and relative humidity for at least 24 h prior to testing.4.6 Preparation of material for testingManipulate all the components of the sealer in accordance with the manufacturers instructions for use.5 Test methods5.1 Extrane

42、ous matterExamine under normal visual acuity.5.2 Flow5.2.1 Apparatus5.2.1.1 Two glass plates, at least 40 mm 40 mm and approximately 5 mm thick, and with a mass of approximately 20 g.5.2.1.2 A weight with a mass of approximately 100 g.5.2.1.3 Graduated syringe, designed to deliver (0,05 0,005) ml of

43、 mixed sealer.5.2.2 ProcedurePlace (0,05 0,005) ml of sealer on the centre of one of the glass plates using the graduated syringe.NOTE An alternative method is to use the mass of the sample, having first determined the density, and use the formula:m = V dwherem is mass;d is density;V is volume.At (1

44、80 5) s after the commencement of mixing, place the second glass plate centrally on top of the sealer and an additional mass on the plate to total (120 2) g. Ten minutes after the commencement of mixing, remove the weight and measure the maximum and minimum diameters of the compressed disc of sealer

45、. If the diameters are within 1 mm of each other, record the mean of the two diameters. If the two diameters are not within 1 mm of each other, repeat the test.5.2.3 Calculation and expression of resultsCarry out three determinations and calculate the mean value. Round the result to the nearest inte

46、ger in millimetres and record it as the flow value. ISO 2012 All rights reserved 3BS EN ISO 6876:2012ISO 6876:2012(E)5.3 Working timeIn order to determine the working time for sealers whose claimed working time is up to 30 min, use the procedure set out in 5.2 with the exception that the load is app

47、lied 15 s before the end of the manufacturers stated working time.5.4 Setting time5.4.1 Apparatus5.4.1.1 Cabinet, capable of being maintained at (37 1) C and not less than 95 % RH.5.4.1.2 Gilmore-type metric indenter, having a mass of (100,0 0,5) g and a flat end of diameter (2,0 0,1) mm. The needle

48、 tip shall be cylindrical over a distance of at least 5 mm. The end of the needle shall be plane and at right angles to the longitudinal axis.5.4.1.3 Mouldsa) For materials that do not require moisture for setting, a stainless steel ring mould, having an internal diameter of 10 mm and a height of 2

49、mm.b) For materials that do require moisture for setting, a gypsum mould (complying with Type 2 of ISO 6873) incorporating a cavity with a diameter of 10 mm and a height of 1 mm. NOTE This mould can be made by placing a plastics disc (D = 10 mm, h = 1 mm) on the bottom of a plastics cup (1 ml to 2 ml capacity) and filling the cup with freshly mixed gypsum. After the gypsum has set, the cup and disc are removed.5.4.1.4 Metal block, with dimensions of at least 8 mm 20 mm 10 mm, conditioned at (37 1) C in t