EN ISO 10139-2-2009 6875 Dentistry - Soft lining materials for removable dentures - Part 2 Materials for long-term use《牙科 活动假牙用弹性衬料 第2部分 长期材料》.pdf

1、BS EN ISO10139-2:2009ICS 11.060.10NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDDentistry Softlining materials forremovable denturesPart 2: Materials for long-term use(ISO 10139-2:2009)Copyright European Committee for Standardization Provided by IHS under lice

2、nse with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-This British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 31 August2009 BSI 2009ISBN 978 0 580 59584 4Amendments/corrigenda issued since publicationDate Comments

3、BS EN ISO 10139-2:2009National forewordThis British Standard is the UK implementation of EN ISO10139-2:2009. It is identical to ISO 10139-2:2009. It supersedes BS ENISO 10139-2:2001 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/2, Prosthodontic

4、 materials.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immun

5、ityfrom legal obligations.Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 10139-2August 2009ICS 11.060.10 Supersedes EN ISO

6、10139-2:2001 English VersionDentistry - Soft lining materials for removable dentures - Part 2:Materials for long-term use (ISO 10139-2:2009)Art dentaire - Produits souples pour intrados de prothsesdentaires amovibles - Partie 2: Produits pour usage longterme (ISO 10139-2:2009)Zahnheilkunde - Weichbl

7、eibende Unterftterungswerkstoffefr Prothesen - Teil 2: Werkstoffe fr dieLangzeitanwendung (ISO 10139-2:2009)This European Standard was approved by CEN on 31 July 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStan

8、dard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French,

9、 German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech

10、 Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN D

11、E NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 10139-2:2009: ECopyright European Committee for Standardization Provided by IH

12、S under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 10139-2:2009EN ISO 10139-2:2009 (E) 3 Foreword This document (EN ISO 10139-2:2009) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration with by Technical C

13、ommittee 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 February 2010, and conflicting national standards shall be withdrawn at the

14、 latest by February 2010. 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 10139-2:2001. According to t

15、he CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithua

16、nia, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 10139-2:2009 has been approved by CEN as a EN ISO 10139-2:2009 without any modification. Copyright European Committee for

17、Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 10139-2:2009ISO 10139-2:2009(E) ISO 2009 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms a

18、nd definitions. 1 4 Classification. 2 5 Requirements 2 5.1 Shore A hardness, 24 h 2 5.2 Shore A hardness, 28 d 2 5.3 Bond strength . 2 5.4 Sorption . 2 5.5 Solubility 2 6 Sampling 3 7 Test methods. 3 7.1 Test conditions . 3 7.2 Shore A hardness . 3 7.3 Bond strength . 4 7.4 Water sorption and solubi

19、lity 6 8 Requirements for packaging, marking and instructions supplied by manufacturer. 9 8.1 Packaging 9 8.2 Marking 10 8.3 Manufacturers instructions for use . 10 Bibliography . 12 Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction

20、or networking permitted without license from IHS-,-,-BS EN ISO 10139-2:2009ISO 10139-2:2009(E) iv ISO 2009 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing Internatio

21、nal 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

22、, also take part in the work. ISO collaborates closely with the 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 com

23、mittees is to prepare International Standards. Draft International 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

24、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. ISO 10139-2 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials. This second

25、edition cancels and replaces the first edition (ISO 10139-2:1999) which has been technically revised. ISO 10139 consists of the following parts, under the general title Dentistry Soft lining materials for removable dentures: Part 1: Materials for short-term use Part 2: Materials for long-term use Co

26、pyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 10139-2:2009ISO 10139-2:2009(E) ISO 2009 All rights reserved vIntroduction Denture lining materials for long-term use are

27、classified in this part of ISO 10139 according to their softness. Although 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. In this

28、 second edition of this part of ISO 10139, additional requirements for bond strength to denture base are added, as well as requirements for water sorption and solubility. A new test for the determination of the softness of the lining materials, the Shore A hardness test, has been introduced. This te

29、st cancels and replaces the penetration test of the first edition of this part of ISO 10139. Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this part of ISO 10139. Information relevant to assessing possible biological or toxicological hazard

30、s is given in ISO 7405 and ISO 10993-1. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 10139-2:2009Copyright European Committee for Standardization Provided by IHS und

31、er license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 10139-2:2009INTERNATIONAL STANDARD ISO 10139-2:2009(E) ISO 2009 All rights reserved 1Dentistry Soft lining materials for removable dentures Part 2: Materials for long-term use 1 Scope This

32、 part of 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 Normat

33、ive references The 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 Vocabulary ISO

34、 3696, Water for analytical laboratory use Specification and test methods ISO 6344-1, Coated abrasives Grain size analysis Part 1: Grain size distribution test ISO 7619-1, Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness) ISO 8601, Da

35、ta elements and interchange formats Information exchange Representation of dates and times ISO 20795-1, Dentistry Base polymers Part 1: Denture base polymers 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply. 3.1 soft dentu

36、re lining material soft resilient material bonded to the fitting surface of a denture to reduce trauma to the supporting tissues 3.2 long-term use use for a period of more than 28 d 3.3 immediate container container that is in direct contact with the material Copyright European Committee for Standar

37、dization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 10139-2:2009ISO 10139-2:2009(E) 2 ISO 2009 All rights reserved4 Classification Soft lining materials for long-term use are classified into the following types a

38、ccording to Shore A hardness of 24 h specimens (see 5.1) as determined in accordance with 7.2. Type A: soft; Type B: extra soft. 5 Requirements 5.1 Shore A hardness, 24 h When 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 t

39、he 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 specified in Table 1. If the results for two or more specimens are gr

40、eater than 50, the material shall be deemed not to conform to this part of ISO 10139. Table 1 Shore A hardness, 24 h 5 s Type Shore A (24 h 5 s) A (soft) 25 Shore A u 50 B (extra soft) Shore A u 25 5.2 Shore A hardness, 28 d When 28 d test specimens are subjected to a 5 s Shore A hardness test in ac

41、cordance 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 greater than 35 for Type B materials, the material shall be d

42、eemed not to conform to this part of ISO 10139. Table 2 Shore A hardness, 28 d 5 s Type Shore A (28 d 5 s) A (soft) u 55 B (extra soft) u 35 5.3 Bond strength The bond strength of the lining material to denture base shall be at least 1,0 MPa for eight out of ten tested specimens for Type A materials

43、, 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 Sorption The 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

44、accordance with 7.4. 5.5 Solubility The 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. Copyright European Committee for Standardization Provided by IHS under licens

45、e with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 10139-2:2009ISO 10139-2:2009(E) ISO 2009 All rights reserved 3If the loss in mass per volume (water solubility) does exceed 3 g/mm3for at least two out of five tested specimens when the processed l

46、ining 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 Sampling The test sample shall consist of a retail package, or packages, from the same batch and containing enough material to carry out the sp

47、ecified tests, plus an allowance for any repeat tests, if necessary. 7 Test methods 7.1 Test conditions Unless 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 hardness 7.2

48、.1 Apparatus 7.2.1.1 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, constructed using a smooth metal or polymer disc as a template. A mould release agent, e.g. Teflon spray, may be used to avoid the adherence of material. 7.2.1.4 Timing device, accurate to 0,