EN ISO 10139-1-2018 en Dentistry - Soft lining materials for removable dentures - Part 1 Materials for short-term use.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Dentistry - Soft lining materials for removable denturesPart 1: Materials for short-term useBS EN ISO 10139-1:2018National forewordThis British Standard is the UK implementation of EN ISO 10139-1:2018. It is identical t

2、o ISO 10139-1:2018. It supersedes BS EN ISO 10139-1:2005, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/106/2, Prosthodontic materials.A list of organizations represented on this committee can be obtained on request to its secretary.This publicati

3、on does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 90224 6ICS 11.060.10Compliance with a British Standard cannot confer immunity fro

4、m legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 10139-1:2018EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 10139-

5、1May 2018ICS 11.060.10 Supersedes EN ISO 10139-1:2005EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2018 CEN Ref. No. EN ISO 10139-1:2018: EAll rights of exploitation in any form and b

6、y any means reserved worldwide for CEN national MembersDentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use (ISO 10139-1:2018)Mdecine bucco-dentaire - Produits souples pour intrados de prothses dentaires amovibles - Partie 1: Produits pour usage court terme

7、 (ISO 10139-1:2018)Zahnheilkunde - Weichbleibende Unterftterungswerkstoffe fr Prothesen - Teil 1: Werkstoffe fr kurzzeitige Anwendungen (ISO 10139-1:2018)This European Standard was approved by CEN on 23 April 2018.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipul

8、ate 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 CEN-CENELEC Management Centre or to any CEN member.This European Sta

9、ndard 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 Centre has the same status as the official versions.CEN members are the nat

10、ional 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, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Se

11、rbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 10139-1:2018 (E)European forewordThis document (EN ISO 10139-1:2018) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration with Technical Committee CEN/TC 55 “Dentistry” t

12、he 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 November 2018, and conflicting national standards shall be withdrawn at the latest by November 2018.Attention

13、 is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.This document supersedes EN ISO 10139-1:2005.According to the CEN-CENELEC Internal Regulations, the national st

14、andards 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, Lithuania,

15、 Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 10139-1:2018 has been approved by CEN as EN ISO 10139-1:2018 without any modification.2BS EN ISO 10139-1:2018ISO

16、 10139-1:2018Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Classification 24.1 Types 24.2 Classes 25 Requirements 25.1 Shore A0 hardness . 25.1.1 Shore A0 hardness at 2 h 25.1.2 Shore A0 hardness at 7 d 25.2 Consistency 25.3 Detail reproduction . 36 Samplin

17、g 37 Test methods . 37.1 Ambient conditions for testing . 37.2 Shore A0 hardness . 37.2.1 Apparatus . 37.2.2 Procedure . 37.3 Consistency test . 57.3.1 Test conditions. 57.3.2 Apparatus . 57.3.3 Test procedure . 57.4 Detail reproduction test 57.4.1 General 57.4.2 Apparatus . 57.4.3 Procedure . 68 Re

18、quirement for packaging, marking and instructions supplied by the manufacturer 88.1 Packaging . 88.2 Marking and manufacturers instructions for use 8Bibliography .10 ISO 2018 All rights reserved iiiContents PageBS EN ISO 10139-1:2018ISO 10139-1:2018ForewordISO (the International Organization for Sta

19、ndardization) is a 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 righ

20、t 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 International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures

21、used to develop this 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 rule

22、s of the ISO/IEC Directives, 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 identif

23、ied during the development 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

24、the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword

25、.html.This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials.This third edition cancels and replaces the second edition (ISO 10139-1:2005), which has been technically revised. It also incorporates the Technical Corrigendum ISO 10139-1:2005

26、/Cor.1:2006.A list of all parts in the ISO 10139 series can be found on the ISO website.iv ISO 2018 All rights reservedBS EN ISO 10139-1:2018ISO 10139-1:2018IntroductionClinically, short-term denture-lining materials are used commonly as tissue conditioners and as temporary soft lining materials. Fu

27、rthermore, some materials are also indicated for functional impression taking. Therefore, the tests are designed to cover the more common usages.It is recognized that the short-term material, when used as a tissue conditioner, is commonly changed every few days with the aim of returning the mucosa t

28、o a healthy condition as quickly as possible. As a temporary soft lining, the material is commonly placed in immediate dentures and in dentures that need to be modified as part of implant treatment. Therefore the specification has been so designed to necessitate that a material exhibit the required

29、properties over a 7 d period. It is of course recognized that there are a number of clinical situations where it is appropriate to retain the soft lining in the denture for periods longer than 7 d. It is also recognized that manufacturers may wish to provide more than one set of times, temperatures,

30、 proportions and procedures to mix or prepare the material properly in order that the material can satisfy the requirements of more than one type or class.In an attempt to establish some degree of harmony with the procedures used to evaluate related dental materials, the detail reproduction test has

31、 been adopted for materials also used for functional impression taking (ISO 4823). As well, in this revision of the standard, the Shore A0 hardness test has replaced the depth of penetration test, and the consistency test has been reintroduced as a replacement of the elastic recovery test due to com

32、plexity of this method.Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological hazards are not included in this document, but it is recommended that, for the assessment of possible biological hazards, reference should be made to ISO 10993-1 and ISO 7

33、405. ISO 2018 All rights reserved vBS EN ISO 10139-1:2018This page deliberately left blankDentistry - Soft lining materials for removable dentures Part 1: Materials for short-term use1 ScopeThis document specifies requirements for the physical properties, test methods, packaging, marking and manufac

34、turers instructions for soft denture lining materials suitable for short-term use, including functional impression taking using existing removable prosthesis.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirem

35、ents 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 3696, Water for analytical laboratory use Specification and test methodsISO 4823:2015, Dentistry Elastomeric impre

36、ssion materialsISO 7619-1, Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness)ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times3 Terms and definitionsFor the purposes of this docum

37、ent, the following terms and definitions apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at https:/www.iso.org/obp3.1soft denture lining mater

38、ialsoft resilient material bonded to the fitting surface of a denture to reduce trauma to the supporting tissuesNote 1 to entry: A soft lining material can be used as a tissue conditioning material when placed in the fitting surface of a denture and intended to be in contact with the denture-support

39、ing mucosa, commonly for a period of up to 7 d, with the aim of assisting its return to a healthy condition.3.2short-term useuse normally for a continuous period of between 60 minutes and 30 days3.3functional impression takinguse of a soft denture lining material (3.1) to take a functional impressio

40、n using existing removable prosthesisINTERNATIONAL STANDARD ISO 10139-1:2018 ISO 2018 All rights reserved 1BS EN ISO 10139-1:2018ISO 10139-1:20184 Classification4.1 TypesMaterials for short-term use shall be classified into the following types in accordance with Shore A0 hardness test at 2 h (5.1.1)

41、 as determined in accordance with 7.2: Type A: soft materials; Type B: extra soft materials.4.2 ClassesThe materials shall be further subdivided into classes in accordance with consistency (5.2) as determined in accordance with 7.3: Class 1: medium flow materials; Class 2: high flow materials.5 Requ

42、irements5.1 Shore A0 hardness5.1.1 Shore A0 hardness at 2 hWhen 2 h old test specimens are subjected to the Shore A0 hardness test in accordance with 7.2, the individual mean Shore A0-value for three specimens of the material shall conform to the requirements in Table 1. If only two or fewer specime

43、ns meet the requirement, the material shall be deemed not to conform to this document.Table 1 Shore A0 hardnessType Shore A0 hardness, 2 hA (soft) 30 15 mm from the edge and 6 mm apartFigure 1 Shore A0 hardness specimen and testing points7.2.2.2 Shore A0 hardness test, 2 h specimenAfter (120 5) min

44、immersion, remove the test specimen from the mould and measure the Shore A0 hardness as described below within 3 min after having removed the specimen from the water bath. Place the specimen on a flat and solid base. Using the stand, lower the Shore A0 hardness tester slowly onto the surface of the

45、specimen, ensuring that the specimen surface is coplanar with the surface of the hardness tester, until the indenter foot just touches the specimen surface. Record the values 5 s after loading, using a timing device. Repeat the test using four more loading points ensuring that no measurement is made

46、 closer than 6 mm to a previous one. All the loading points shall be at least 15 mm inside from the edge of the specimen. Each loading point shall be 90 from another loading point and the 5th point shall be on the centre of the specimen (see Figure 1).Return the specimens to the water bath at (37 1)

47、 C and maintain them for an additional 7 d.Carry out the test on all three specimens, and calculate the mean of the five Shore A0 values for each specimen.7.2.2.3 Shore A0 hardness test, 7 d specimenRemove the specimen from the water bath 7 d after the first testing, and measure the Shore A0 hardnes

48、s as described in 7.2.2.2 on the opposite side of the 2 h measurement within 3 min after having removed the specimen from the water bath.Carry out the test on all three specimens, and calculate the mean of the five Shore A0 values for each specimen.4 ISO 2018 All rights reservedBS EN ISO 10139-1:201

49、8ISO 10139-1:20187.3 Consistency test7.3.1 Test conditionsAllow the test apparatus (“upper” glass plate and weight) to reach equilibrium in the environment of (37 1) C for at least 30 min before testing.7.3.2 Apparatus7.3.2.1 Delivery tube or syringe, for example, glass or polytetrafluoroethylene (PTFE), capable of dispensing a volume in excess of sample size i.e. in excess of (2 0,1) ml.7.3.2.2 Two glass plates of size 100 mm by 100 mm, one of which (the “upper” plate) has a mass of (100 1) g and a thickness of not l