EN ISO 10139-2-2016 en Dentistry - Soft lining materials for removable dentures - Part 2 Materials for long-term use《牙科学 活动义齿软衬材料 第2部分 长期使用的材料》.pdf

1、BS EN ISO 10139-2:2016Dentistry Soft liningmaterials for removabledenturesPart 2: Materials for long-term use (ISO10139-2:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 10139-2:2016 BRITISH STANDARDNational forewordThis British Standard is the UK impl

2、ementation of EN ISO10139-2:2016. It supersedes BS EN ISO 10139-2:2009 which iswithdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/2, Prosthodontic 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 2016. Published by BSI StandardsLimited 2016ISBN 978 0 580 92758 4ICS 11.060.10Compliance with a British Standard cannot confer immu

4、nity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 July 2016.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10139-2 July 2016 ICS 11.060.10 Supersedes EN

5、 ISO 10139-2:2009English Version Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use (ISO 10139-2:2016) Mdecine bucco-dentaire - Produits souples pour intrados de prothses dentaires amovibles - Partie 2: Produits pour usage long terme (ISO 10139-2:2016)Zahn

6、heilkunde - Weichbleibende Unterftterungswerkstoffe fr Prothesen - Teil 2: Werkstoffe fr die Langzeitanwendung (ISO/FDIS 10139-2:2016) This European Standard was approved by CEN on 12 May 2016. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions f

7、or 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 thr

8、ee 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 bo

9、dies 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,

10、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-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldw

11、ide for CEN national Members. Ref. No. EN ISO 10139-2:2016 EBS EN ISO 10139-2:2016EN ISO 10139-2:2016 (E) 3 European foreword This document (EN ISO 10139-2:2016) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secret

12、ariat 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 2017, and conflicting national standards shall be withdrawn at the latest by January 2017. Attention is drawn

13、 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 10139-2:2009. According to the CEN-CENELEC Internal Regulations, the nat

14、ional 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, Li

15、thuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 10139-2:2016 has been approved by CEN as EN ISO 10139-2:2016 without any modification. BS EN ISO 10139-2:2016I

16、SO 10139-2:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Classification 25 Requirements 25.1 Shore A hardness, 24 h . 25.2 Shore A hardness, 30 d . 25.3 Bond strength. 25.4 Sorption . 25.5 Solubility 26 Sampling 37 Test methods . 37.1 Test conditions

17、 37.2 Shore A hardness 37.2.1 Apparatus . 37.2.2 Preparation of test samples 37.2.3 Procedure . 37.2.4 Expression of results 47.3 Bond strength. 47.3.1 Materials . 47.3.2 Preparation of acrylic denture base plates . 47.3.3 Preparation of test specimens 57.3.4 Procedure for tensile testing . 57.4 Wat

18、er sorption and solubility 67.4.1 Materials . 67.4.2 Apparatus . 77.4.3 Preparation of test specimens 87.4.4 Procedure . 87.4.5 Calculation and expression of results 98 Requirements for packaging, marking and instructions supplied by manufacturer . 98.1 Packaging . 98.2 Marking . 98.3 Manufacturers

19、instructions for use 10Bibliography .12 ISO 2016 All rights reserved iiiContents PageBS EN ISO 10139-2:2016ISO 10139-2:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing Internation

20、al 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, governmental and non-governmental, in liaison with ISO,

21、 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 maintenance are described in the ISO/IEC Directives, Part

22、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).Attention is drawn to the possibility that some of the ele

23、ments 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 Introduction and/or on the ISO list of patent declarations receiv

24、ed (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 conformity assessment, as well as information about ISOs adher

25、ence 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 SC 2, Prosthodontic materials.This third edition cancels and replaces the second edition (

26、ISO 10139-2:2009), of which it constitutes a minor revision to harmonize the definition of long-term use with other international definitions (30 days).ISO 10139 consists of the following parts, under the general title Dentistry Soft lining materials for removable dentures: Part 1: Materials for sho

27、rt-term use Part 2: Materials for long-term useiv ISO 2016 All rights reservedBS EN ISO 10139-2:2016ISO 10139-2:2016(E)IntroductionDenture lining materials for long-term use are classified in this part of ISO 10139 according to their softness. Although it is not claimed that any particular level of

28、softness is superior to another, this classification is intended to assist clinicians because clinicians will have more information with which to make an informed choice.Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this part of ISO 10139.

29、Information relevant to assessing possible biological or toxicological hazards is given in ISO 7405 and ISO 10993-1. ISO 2016 All rights reserved vBS EN ISO 10139-2:2016BS EN ISO 10139-2:2016Dentistry Soft lining materials for removable dentures Part 2: Materials for long-term use1 ScopeThis part of

30、 ISO 10139 specifies requirements for softness, adhesion, water sorption and water solubility, as well as for packaging, marking and manufacturers instructions for soft denture lining materials suitable for long-term use. These materials may also be used for maxillofacial prostheses.2 Normative refe

31、rencesThe following referenced 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)

32、 applies.ISO 1942, Dentistry VocabularyISO 3696, Water for analytical laboratory use Specification and test methodsISO 6344-1, Coated abrasives Grain size analysis Part 1: Grain size distribution testISO 7619-1, Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durome

33、ter method (Shore hardness)ISO 8601, Data elements and interchange formats Information interchange Representation of dates and timesISO 20795-1, Dentistry Base polymers Part 1: Denture base polymers3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942

34、and the following apply.3.1soft denture lining materialsoft resilient material bonded to the fitting surface of a denture to reduce trauma to the supporting tissues3.2long-term useuse for a period of more than 30 d3.3immediate containercontainer that is in direct contact with the materialINTERNATION

35、AL STANDARD ISO 10139-2:2016(E) ISO 2016 All rights reserved 1BS EN ISO 10139-2:2016ISO 10139-2:2016(E)4 ClassificationSoft lining materials for long-term use are classified into the following types according to Shore A hardness of 24 h specimens (5.1) as determined in accordance with 7.2: Type A: s

36、oft; Type B: extra soft.5 Requirements5.1 Shore A hardness, 24 hWhen 24 h test specimens are subjected to a 5 s Shore A hardness test in accordance with 7.2.3.2, the material shall conform to the requirements for the relevant type as shown in Table 1. For a material to be classified as a particular

37、type, the mean Shore A hardness for at least two of the three specimens shall conform to the requirements for that type, as specified in Table 1. If the results for two or more specimens are greater than 50, the material shall be deemed not to conform to this part of ISO 10139.Table 1 Shore A hardne

38、ss, 24 h 5 sType Shore A (24 h 5 s)A (soft) 25 Shore A 50B (extra soft) Shore A 255.2 Shore A hardness, 30 dWhen 30 d test specimens are subjected to a 5 s Shore A hardness test in accordance with 7.2.3.3, the material shall conform to the requirements for the relevant type as shown in Table 2 for a

39、t least two of the three specimens. If the results for two or more specimens are greater than 55 for Type A materials or greater than 35 for Type B materials, the material shall be deemed not to conform to this part of ISO 10139.Table 2 Shore A hardness, 30 d 5 sType Shore A (30 d 5 s)A (soft) 55B (

40、extra soft) 355.3 Bond strengthThe bond strength of the lining material to denture base shall be at least 1,0 MPa for eight out of 10 tested specimens for Type A materials and at least 0,5 MPa for eight out of ten tested specimens for Type B materials when tested in accordance with 7.3.5.4 SorptionT

41、he increase in mass per volume (water sorption) shall not exceed 20 g/mm3for at least four out of five tested specimens when the processed lining material is tested in accordance with 7.4.5.5 SolubilityThe loss in mass per volume (water solubility) shall not exceed 3 g/mm3for at least four out of fi

42、ve tested specimens when the processed lining material is tested in accordance with 7.4.2 ISO 2016 All rights reservedBS EN ISO 10139-2:2016ISO 10139-2:2016(E)If the loss in mass per volume (water solubility) does exceed 3 g/mm3for at least two out of five tested specimens when the processed lining

43、material is tested in accordance with 7.4, the manufacturer of the material shall state the amount and the nature of the solubles from the material.6 SamplingThe test sample shall consist of a retail package, or packages, from the same batch and containing enough material to carry out the specified

44、tests, plus an allowance for any repeat tests, if necessary.7 Test methods7.1 Test conditionsUnless specified otherwise by the manufacturer, prepare and test all specimens at a temperature of (23 2) C. Measurement equipment shall be used in a calibrated condition.7.2 Shore A hardness7.2.1 Apparatus7

45、.2.1.1 Shore A hardness equipment, corresponding to ISO 7619-1 with a precision of 1 HS.7.2.1.2 Water bath, capable of being maintained at (37 1) C, with water complying with grade 2 of ISO 3696.7.2.1.3 Mould, suitable for producing test specimens of at least 35 mm diameter and at least 6 mm thick,

46、constructed using a smooth metal or polymer disc as a template. A mould release agent, e.g. Polytetrafluoroethylene (PTFE) spray, may be used to avoid the adherence of material.7.2.1.4 Timing device, accurate to 0,1 s.7.2.2 Preparation of test samplesPrepare each test specimen in the mould cavity in

47、 accordance with the manufacturers instructions. Remove the specimen from the mould (7.2.1.3) and store it in the water bath (7.2.1.2) at (37 1) C for (24 1) h prior to testing. Prepare the three test specimens.7.2.3 Procedure7.2.3.1 GeneralCarry out the test procedure in accordance with 7.2.3.2, 7.

48、2.3.3 and ISO 7619-1 on each of the three test specimens. For the measurements, place the specimens on a flat and solid base and lower the Shore A hardness tester (7.2.1.1) gradually onto the surface of the specimen in such a way that the indenter foot just touches the specimen surface. The surface

49、of the specimens and the contact surface of the Shore A hardness tester shall be coplanar. Ensure that the indenter is normal to the specimen surface. Five measurements shall be made for each of the specimens at each testing time. The loading points shall be uniformly distributed on the surface and shall have a distance of at least 5 mm from the edge of the specimen.7.2.3.2 Shore A hardness test, 24 h specimenRemove the specimen from the water (7.2.1.2) bath 24 h after preparation and measu