DIN EN ISO 10139-2-2016 Dentistry - Soft lining materials for removable dentures - Part 2 Materials for long-term use (ISO 10139-2 2016) German version EN ISO 10139-2 2016《牙科学 可摘义齿.pdf

1、December 2016 English price group 12No 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!%“2595796www.din.deDI

2、N EN ISO 10139-2Dentistry Soft lining materials for removable dentures Part 2: Materials for longterm use (ISO 101392:2016);English version EN ISO 101392:2016,English translation of DIN EN ISO 10139-2:2016-12Zahnheilkunde Weichbleibende Unterftterungswerkstoffe fr Prothesen Teil 2: Werkstoffe fr die

3、 Langzeitanwendung (ISO 101392:2016);Englische Fassung EN ISO 101392:2016,Englische bersetzung von DIN EN ISO 10139-2:2016-12Mdecine buccodentaire Produits souples pour intrados de prothses dentaires amovibles Partie 2: Produits pour usage long terme (ISO 101392:2016);Version anglaise EN ISO 101392:

4、2016,Traduction anglaise de DIN EN ISO 10139-2:2016-12SupersedesDIN EN ISO 101392:201001www.beuth.deDocument comprises 21 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.12.16 DIN EN ISO 10139-2:2016-12 2 A comma is used as the

5、 decimal marker. National 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” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenau

6、sschuss Dental (DIN Standards Committee Dentistry), Working Committee NA 014-00-02 AA Polymere Prothetikwerkstoffe. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 1942 DIN EN ISO 1942 ISO 3696 DIN ISO 3696 ISO 6344-1 DIN ISO 6344-1 ISO

7、 7619-1 DIN ISO 7619-1 ISO 8601 DIN ISO 8601 ISO 20795-1 DIN EN ISO 20795-1 Amendments This standard differs from DIN EN ISO 10139-2:2010-01 as follows: a) in the definition for “long-term use” the period has been increased from more than 28 days to more than 30 days; b) additional requirements on w

8、ater sorption and water solubility have been included; c) the Shore A hardness test has been included as a new test method for determining the level of softness of denture lining materials. Previous editions DIN EN ISO 10139-2: 2001-12, 2010-01 DIN EN ISO 10139-2:2016-12 3 National Annex NA (informa

9、tive) Bibliography DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 20795-1, Dentistry Base polymers Part 1: Denture base polymers DIN ISO 3696, Water for analytical laboratory use Specification and test methods DIN ISO 6344-1, Coated abrasives Grain size analysis Part 1: Grain size distribution tes

10、t DIN ISO 7619-1, Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness) DIN ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times DIN EN ISO 10139-2:2016-12 4 This page is intentionally

11、blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10139-2 July 2016 ICS 11.060.10 Supersedes EN 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 pou

12、r intrados de prothses dentaires amovibles - Partie 2: Produits pour usage long terme (ISO 10139-2:2016)Zahnheilkunde - 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.

13、 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 national standards may be obtained on

14、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 language and notified to the CEN-CENELE

15、C 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, Greece, Hungary, Iceland, Ireland, Italy,

16、 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 CEN-CENELEC Management Centre: Avenue

17、Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10139-2:2016 EEuropean foreword 3Introduction 51 Scope . 62 Normative references 63 Terms and definitions . 64 Classification 75 Requirements 75.1

18、Shore A hardness, 24 h . 75.2 Shore A hardness, 30 d . 75.3 Bond strength. 75.4 Sorption . 75.5 Solubility 76 Sampling 37 Test methods . 87.1 Test conditions 87.2 Shore A hardness 87.2.1 Apparatus . 87.2.2 Preparation of test samples 87.2.3 Procedure . 87.2.4 Expression of results 97.3 Bond strength

19、. 97.3.1 Materials . 97.3.2 Preparation of acrylic denture base plates . 97.3.3 Preparation of test specimens . 107.3.4 Procedure for tensile testing 107.4 Water sorption and solubility . 117.4.1 Materials 117.4.2 Apparatus 127.4.3 Preparation of test specimens . 137.4.4 Procedure 137.4.5 Calculatio

20、n and expression of results . 148 Requirements for packaging, marking and instructions supplied by manufacturer 148.1 Packaging 148.2 Marking 148.3 Manufacturers instructions for use 15Bibliography .17Contents PageDIN EN ISO 10139-2:2016-12 EN ISO 10139-2:2016 (E)2Foreword 4European foreword This do

21、cument (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 secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an i

22、dentical 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 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 h

23、eld 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 national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, C

24、roatia, 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, Spain, Sweden, Switzerland, Turkey an

25、d 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. DIN EN ISO 10139-2:2016-12 EN ISO 10139-2:2016 (E)3 ForewordISO (the International Organization for Standardization) is a worldwide federation of national s

26、tandards 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 represented on that committee. International

27、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 this document and those intended for

28、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 Directives, Part 2 (see www.iso.org/

29、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 development of the document will be in

30、 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 specific terms and expressions rel

31、ated 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, Subcommittee SC 2, Prosthodontic

32、materials.This third edition cancels and replaces the second edition (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 S

33、oft lining materials for removable dentures: Part 1: Materials for short-term use Part 2: Materials for long-term useDIN EN ISO 10139-2:2016-12 EN ISO 10139-2:2016 (E)4 IntroductionDenture lining materials for long-term use are classified in this part of ISO 10139 according to their softness. Althou

34、gh it is not claimed that any particular level of 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 h

35、azard are not included in this part of ISO 10139. Information relevant to assessing possible biological or toxicological hazards is given in ISO 7405 and ISO 10993-1.DIN EN ISO 10139-2:2016-12 EN ISO 10139-2:2016 (E)5 1 ScopeThis part of ISO 10139 specifies requirements for softness, adhesion, water

36、 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 referencesThe following referenced documents, in whole or in part,

37、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 3696, Water for anal

38、ytical 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: Durometer method (Shore hardness)ISO 8601, Data elements and intercha

39、nge 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 and the following apply.3.1soft denture lining materialsoft res

40、ilient 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 materialDIN EN ISO 10139-2:2016-12 EN ISO 10139-2:2016 (E)6 4 ClassificationSoft l

41、ining 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: soft; Type B: extra soft.5 Requirements5.1 Shore A hardness, 24 hWhen 24 h test specimens are subjected to a 5 s Shore A hardn

42、ess 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 type, the mean Shore A hardness for at least two of the three specimens shall conform to the requirements for that type, as s

43、pecified 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 hardness, 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 sp

44、ecimens 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 at least two of the three specimens. If the results for two or more specimens are greater than 55 for Type A materials or grea

45、ter 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 (extra soft) 355.3 Bond strengthThe bond strength of the lining material to denture base shall be at least 1,0 MPa for eight o

46、ut 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 SorptionThe increase in mass per volume (water sorption) shall not exceed 20 g/mm3for at least four out of five tested specimens when

47、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 five tested specimens when the processed lining material is tested in accordance with 7.4.DIN EN ISO 10139-2:2016-12 EN ISO 101

48、39-2:2016 (E)7 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 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