BS EN ISO 20795-1-2013 Dentistry Base polymers Denture base polymers《牙科学 原料聚合物 假牙原料聚合物》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 20795-1:2013Part 1: Denture base polymersDentistry Base polymers BS EN ISO 20795-1:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation

2、of EN ISO 20795-1:2013. It supersedes BS EN ISO 20795-1:2008 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/106/2, Prosthodontic materials.A list of organizations represented on this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 public

3、ation does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2013. Published by BSI Standards Limited 2013ISBN 978 0 580 79560 2 ICS 11.060.10 Compliance with a British Standard cannot confer immuni

4、ty from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 March 2013.Amendments issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 20795-1 March 2013 ICS 11.060.10 S

5、upersedes EN ISO 20795-1:2008English Version Dentistry - Base polymers - Part 1: Denture base polymers (ISO 20795-1:2013) Mdecine bucco-dentaire - Polymres de base - Partie 1: Polymres pour base de prothses dentaires (ISO 20795-1:2013) Zahnheilkunde - Kunststoffe - Teil 1: Prothesenkunststoffe (ISO

6、20795-1:2013) This European Standard was approved by CEN on 26 February 2013. 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 bibl

7、iographical 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 three official versions (English, French, German). A version in any other language made by translation under the respon

8、sibility 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 bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Repu

9、blic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMA

10、LISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 20795-1:2013: EBS EN ISO 20795-1:2013EN ISO 20795-1:2013 (E) 3 Foreword This docu

11、ment (EN ISO 20795-1:2013) 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 ide

12、ntical text or by endorsement, at the latest by September 2013, and conflicting national standards shall be withdrawn at the latest by September 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

13、 held responsible for identifying any or all such patent rights. This document supersedes EN ISO 20795-1:2008. 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,

14、 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, Spain, Sweden, Switzerland, Turkey

15、and the United Kingdom. Endorsement notice The text of ISO 20795-1:2013 has been approved by CEN as EN ISO 20795-1:2013 without any modification. BS EN ISO 20795-1:2013ISO 20795-1:2013(E) ISO 2013 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms

16、 and definitions . 24 Classification 35 Requirements 35.1 Unpolymerized material . 35.2 Polymerized material 46 Sampling 67 Preparation of test specimens 67.1 Laboratory environment 67.2 Procedures 77.3 Special equipment 78 Test methods . 78.1 Inspection for compliance determination . 78.2 Packing p

17、lasticity 78.3 Colour 98.4 Colour stability . 108.5 Polishability, translucency, freedom from porosity, ultimate flexural strength, and flexural modulus . 128.6 Fracture toughness with a modified bending test .178.7 Bonding to synthetic polymer teeth 218.8 Residual methyl methacrylate monomer 228.9

18、Water sorption and solubility . 279 Requirements for labelling, marking, packaging, and instructions supplied by the manufacturer 299.1 Packaging 299.2 Marking of outer packages and containers . 309.3 Manufacturers instructions . 31Annex A (normative) HPLC method for determination of MMA content .32

19、Bibliography .35BS EN ISO 20795-1:2013ISO 20795-1:2013(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 committees

20、. 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 Intern

21、ational 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 Stand

22、ards 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 subject

23、 of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 20795-1 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials.This second edition cancels and replaces the first edition (ISO 20795-1:2008), of which

24、 it constitutes a minor revision. It also incorporates the Technical Corrigendum ISO 20795-1:2008/Cor 1:2009.ISO 20795 consists of the following parts, under the general title Dentistry Base polymers: Part 1: Denture base polymers Part 2: Orthodontic base polymersiv ISO 2013 All rights reservedBS EN

25、 ISO 20795-1:2013ISO 20795-1:2013(E)IntroductionSpecific qualitative and quantitative requirements for freedom from biological hazard are not included in this part of ISO 20795, but it is recommended that, in assessing possible biological or toxicological hazards, reference be made to ISO 10993-1 an

26、d ISO 7405. ISO 2013 All rights reserved vBS EN ISO 20795-1:2013BS EN ISO 20795-1:2013Dentistry Base polymers Part 1: Denture base polymers1 Scope1.1 This part of ISO 20795 classifies denture base polymers and copolymers and specifies their requirements. It also specifies the test methods to be used

27、 in determining compliance with these requirements. It further specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for use of these materials. Furthermore, it applies to denture base polymers for which the manufacturer claims that the mate

28、rial has improved impact resistance. It also specifies the respective requirement and the test method to be used.1.2 Although this part of ISO 20795 does not require manufacturers to declare details of the composition, attention is drawn to the fact that some national or international authorities re

29、quire such details to be provided.1.3 This part of ISO 20795 is applicable to denture base polymers such as those listed below:a) poly(acrylic acid esters);b) poly(substituted acrylic acid esters);c) poly(vinyl esters);d) polystyrene;e) rubber modified poly(methacrylic acid esters);f) polycarbonates

30、;g) polysulfones;h) poly(dimethacrylic acid esters);i) polyacetals (polyoxymethylene);j) copolymers or mixtures of the polymers listed in a) to i).2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition c

31、ited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 463, Geometrical Product Specifications (GPS) Dimensional measuring equipment Design and metrological characteristics of mechanical dial gaugesISO 1942, Dentistry VocabularyISO

32、3696:1987, Water for analytical laboratory use Specification and test methodsISO 7491:2000, Dental materials Determination of colour stabilityINTERNATIONAL STANDARD ISO 20795-1:2013(E) ISO 2013 All rights reserved 1BS EN ISO 20795-1:2013ISO 20795-1:2013(E)ISO 8601, Data elements and interchange form

33、ats Information interchange Representation of dates and timesISO 22112:2005, Dentistry Artificial teeth for dental prostheses3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.3.1autopolymerizable materialsproducts having pol

34、ymerization initiated by chemical means and not requiring application of temperatures above 65 C to complete the polymerization3.2capsulated materialmaterial consisting of two or more components supplied in a container that keeps them separated until the time they are mixed together and dispensed fo

35、r use directly from the container3.3dentureartificial substitute for missing natural teeth and adjacent tissues, to also include any additions needed for optimum function3.4denture basethat part of a denture which rests on soft tissue foundations and to which artificial teeth are added3.5heat-polyme

36、rizable materialsproducts requiring application of temperatures above 65 C to complete polymerization3.6immediate containercontainer that is in direct contact with the denture base materials3.7liquidmonomeric liquid to be mixed with polymeric particles to form a mouldable dough or fluid resin mixtur

37、e used for forming denture bases3.8powderpolymeric particles to be mixed with monomeric liquid to form a mouldable dough or fluid resin mixture used for forming denture bases3.9outer packaginglabelled container or wrapping within which other containers are packed3.10packingact of filling a denture b

38、ase mould with a material (using a compression, pour, or injection technique) to form a denture base3.11initial packing timetime after mixing, or other preparation, when a denture base material mixture first reaches packing consistency2 ISO 2013 All rights reservedBS EN ISO 20795-1:2013ISO 20795-1:2

39、013(E)3.12final packing timelast time, after achievement of the initial packing time, at which a denture base material mixture retains packing consistency3.13processingprocedure of preparing a solid denture base polymer plate and/or specimen by polymerization or injection moulding3.14thermoplasticch

40、aracteristic of a hard polymeric material that allows it to be softened by application of heat to make it mouldable, and then return to the hardened state upon cooling3.15translucencycapacity of a body of material to allow the passage of light, yet diffusing the light so as not to render objects lyi

41、ng beyond the body clearly visible4 ClassificationDenture base polymers covered by this part of ISO 20795 are categorized into the following types and classes: Type 1: Heat-polymerizable materials Class 1: Powder and liquid Class 2: Plastic cake Type 2: Autopolymerizable materials Class 1: Powder an

42、d liquid Class 2: Powder and liquid for pour-type resins Type 3: Thermoplastic blank or powder Type 4: Light-activated materials Type 5: Microwave cured materials5 Requirements5.1 Unpolymerized material5.1.1 Liquid component5.1.1.1 GeneralThe liquid shall consist essentially of monomeric material co

43、mpatible with the powder.5.1.1.2 HomogeneityThe liquid shall be free of deposit or sediment that can be observed by visual inspection (see 8.1.1). ISO 2013 All rights reserved 3BS EN ISO 20795-1:2013ISO 20795-1:2013(E)5.1.2 Solid componentsThe solid or semi-solid components shall be free of extraneo

44、us material that can be observed by visual inspection (see 8.1.1).5.1.3 Packing plasticityWhen Type 1 Class 1 and Type 2 Class 1 materials are tested in accordance with 8.2, at the initial packing time recommended by the manufacturer, they shall be capable of being intruded into at least two holes i

45、n the die (8.2.2.1) to a depth of not less than 0,5 mm (see 8.2.4.2). Type 1 Class 1, Type 1 Class 2, and Type 5 materials shall meet the requirements when tested at the final packing time (see 8.2.4.3).5.2 Polymerized material5.2.1 BiocompatibilitySpecific qualitative requirements for freedom from

46、biological hazard are not included in this part of ISO 20795, but it is recommended that, in assessing possible biological or toxicological hazards, reference be made to ISO 10993-1 and ISO 7405.5.2.2 Surface characteristics5.2.2.1 When processed in the manner recommended by the manufacturer and in

47、contact with materials recommended by the manufacturer, denture base specimens prepared in accordance with 8.4.3, 8.8.2.2, and 8.9.3 shall have a smooth, hard, and glossy surface (see 8.1.1).5.2.2.2 The specimens for colour stability, the specimens for residual methyl methacrylate monomer, and the s

48、pecimens for sorption and solubility testing shall retain their form without visible distortion after processing (see 8.1.1).5.2.2.3 When polished in accordance with 8.5.1.4, the specimen plates shall present a smooth surface with a high gloss (see 8.1.1).5.2.3 Shape capabilityWhen prepared in accor

49、dance with the manufacturers instructions, all types of denture base polymers shall produce a test specimen plate with defined edges after deflasking (see 8.5.1.4).5.2.4 ColourThe colour of a specimen strip shall be as stated by the manufacturer when tested in accordance with 8.3 and inspected in accordance with 8.1.1.The manufacturer shall provide a shade guide on request.Coloured denture base polymers shall be translucent (see 5.2.6 and 8.5.2) and pigment and fibres shall be evenly distributed.Clear (transparent) dentu