EN ISO 22112-2006 en Dentistry - Artificial teeth for dental prostheses《牙科学 牙修复术用假牙(ISO 22112-2005)》.pdf

1、BRITISH STANDARDBS EN ISO 22112:2006Dentistry Artificial teeth for dental prosthesesThe European Standard EN ISO 22112:2006 has the status of a British StandardICS 11.060.10g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g5

2、1g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 22112:2006This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 March 2006 BSI ISBN 0 580 47999 4National forewordThis British Standard is the official English la

3、nguage version of EN ISO 22112:2006. It is identical with ISO 22112:2005. It supersedes both BS EN ISO 3336:1996 and BS EN ISO 4824:1997, which are withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/106, Dentistry, to Subcommittee CH/106/2, Prosthodontic materi

4、als, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary.Cross-referencesThe British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under

5、 the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct applic

6、ation. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor

7、 related international and European developments and promulgate them in the UK.Summary of pagesThis document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to iv, pages 1 to 16, an inside back cover and a back cover.The B

8、SI copyright notice displayed in this document indicates when the document was last issued.Amendments issued since publicationAmd. No. Date CommentsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 22112March 2006ICS 11.060.10English VersionDentistry - Artificial teeth for dental prostheses (ISO

9、22112:2005)Art dentaire - Dents artificielles pour prothses dentaires(ISO 22112:2005)Zahnheilkunde - Knstliche Zhne fr Dentalprothesen(ISO 22112:2005)This European Standard was approved by CEN on 6 February 2006.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulat

10、e the conditions for giving this EuropeanStandard 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 Central Secretariat or to any CEN member.This European Standard exists i

11、n three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of

12、Austria, Belgium, Cyprus, Czech 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

13、 STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 22112:2006: EForeword The text of ISO 22112:2

14、005 has been prepared by Technical Committee ISO/TC 106 “Dentistry” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 22112:2006 by Technical Committee CEN/TC 55 “Dentistry“, the secretariat of which is held by DIN. This European Standard shall be given th

15、e status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2006, and conflicting national standards shall be withdrawn at the latest by September 2006. According to the CEN/CENELEC Internal Regulations, the national standards organizatio

16、ns of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia,

17、 Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 22112:2005 has been approved by CEN as EN ISO 22112:2006 without any modifications. EN ISO 22112:2006Reference numberISO 22112:2005(E)INTERNATIONAL STANDARD ISO22112First edition2005-11-01Dentistry Artificia

18、l teeth for dental prostheses Art dentaire Dents artificielles pour prothses dentaires EN ISO 22112:2006ii iiiContents Page Foreword iv 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 1 4 Classification. 2 5 Requirements 2 5.1 General. 2 5.2 Ceramic teeth 3 5.3 Synthetic polymer teet

19、h . 3 6 Sampling 3 7 Inspection and test methods . 4 7.1 Visual inspection 4 7.2 Dimensions of teeth 4 7.3 Comparison with shade guide. 4 7.4 Surface finish of ceramic teeth . 5 7.5 Surface finish of synthetic polymer teeth 5 7.6 Porosity of ceramic teeth. 6 7.7 Porosity of synthetic polymer teeth a

20、nd other defects 7 7.8 Radioactivity of ceramic teeth. 9 7.9 Anchorage of ceramic teeth to denture base polymers . 9 7.10 Resistance of ceramic teeth to thermal shock 9 7.11 Quality of bonding of synthetic polymer teeth to denture-base polymers. 10 7.12 Resistance to blanching, distortion and crazin

21、g of synthetic polymer teeth. 12 7.13 Colour stability of synthetic polymer teeth 13 7.14 Dimensional stability of synthetic polymer teeth 13 8 Marking, labelling, packaging, and information to be supplied by the manufacturer. 14 8.1 Marking, labelling and packaging . 14 8.2 Information to be suppli

22、ed by manufacturer . 14 8.3 Manufacturers instructions 15 Bibliography . 16 EN ISO 22112:2006iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carr

23、ied 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, also take part in the work.

24、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 committees is to prepare Internat

25、ional 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 possibility that some of the e

26、lements 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 22112 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials. This first edition cancels and replaces ISO

27、3336:1993, ISO 4824:1993 and ISO 4824:1993/Amd. 1:1997 which have been technically revised. EN ISO 22112:20061Dentistry Artificial teeth for dental prostheses 1 Scope This International Standard specifies the classification, requirements, and test methods for synthetic polymer and ceramic teeth that

28、 are manufactured for use in prostheses used in dentistry. 2 Normative 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 (in

29、cluding any amendments) applies. ISO 483 1), Plastics Small enclosures for conditioning and testing using aqueous solutions to maintain the humidity at a constant value ISO 1567:1999, Dentistry Denture base polymers ISO 1942 2), Dentistry Vocabulary ISO 3950:1984, Dentistry Designation system for te

30、eth and areas of the oral cavity ISO 6873:1998, Dental gypsum products ISO 7491:2000, Dental materials Determination of colour stability 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply. 3.1 diatoric teeth teeth designed t

31、o be retained by anchorage slots and/or holes 3.2 pin teeth teeth designed to be retained by headed pins 3.3 set set of six anterior teeth or eight posterior teeth, as received from the manufacturer 1) To be published. (Revision of ISO 483:1988) 2) To be published. Revision of ISO 1942 (all parts):1

32、989 EN ISO 22112:20062 3.4 half-set three teeth on one side of a set of anterior teeth or four teeth on one side of a set of posterior teeth 3.5 mould chart chart representing the form, shape and dimensions of all individual teeth of a set 4 Classification Artificial teeth are grouped in accordance

33、with the following classification: a) Type 1: anterior teeth; b) Type 2: posterior teeth. 5 Requirements 5.1 General 5.1.1 Biocompatibility Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this International Standard, but it is recommended tha

34、t, in assessing possible biological or toxicological hazards, reference be made to ISO 10993-1 and ISO 7405. 5.1.2 Dimensions of teeth The dimensions of the teeth when examined in accordance with 7.2 shall not differ by more than 5 % for synthetic polymer teeth and 7 % for ceramic teeth from the val

35、ues shown in the manufacturers mould chart. 5.1.3 Colour and blending of shades When tested in accordance with 7.3, sets of anterior and posterior teeth shall exhibit no perceptible colour difference compared with the manufacturers shade guide (8.2.2) or nominated shade guide. Blended teeth shall sh

36、ow no line of demarcation between incisal and cervical portions on the facial aspects of the teeth. NOTE This requirement is not intended to disallow especially designed demarcations placed to simulate borders of restorations or enamel imperfections found in natural teeth. 5.1.4 Surface finish When

37、inspected visually in accordance with 7.1, the teeth as received (excluding retention areas) shall have a smooth, lustrous, non-porous surface. When ceramic teeth are tested in accordance with 7.4, the processing shall not have impaired the original finish of the teeth, and the teeth shall be capabl

38、e of being ground and polished. When synthetic polymer teeth are tested in accordance with 7.5, the teeth shall be capable of being polished to restore the original finish. 5.1.5 Freedom from porosity and other defects Ceramic teeth shall not show more than a total of 16 pores of diameter greater th

39、an 30 m on the four test surfaces when tested in accordance with 7.6. No more than six of those pores shall have diameters ranging from W 40 m and u 150 m. There shall be no pores of diameter greater than 150 m. EN ISO 22112:20063Synthetic polymer teeth, when examined in accordance with 7.7, shall e

40、xhibit no porosity or defect, such as rough trimming, rough finish or visible impurities, on the coronal surfaces. 5.2 Ceramic teeth 5.2.1 Radioactivity When tested in accordance with 7.8, ceramic teeth shall have an activity concentration of no more than 1,0 Bqg1of uranium238. 5.2.2 Anchorage All c

41、eramic diatoric teeth, examined in accordance with 7.9, shall provide a means of positive retention and have holes all of which shall be open and unsealed. 5.2.3 Resistance to thermal shock Ceramic teeth shall, when tested in accordance with 7.10, show no signs of cracking. 5.3 Synthetic polymer tee

42、th 5.3.1 Bonding to denture base polymers All synthetic polymer teeth shall be capable of being bonded to heat-polymerized denture-base materials (Type 1), which conform to ISO 1567:1999. For five out of the six test specimens, the bond formed between the ridge lap portion of the teeth and the dentu

43、re base polymer shall pass the test described in 7.11. 5.3.2 Resistance to blanching, distortion and crazing When tested in accordance with 7.12, no teeth shall exhibit blanching or distortion. No teeth shall exhibit crazing with the exception of the ridge lap surfaces and the cervical portion of th

44、e teeth up to the cervical line. 5.3.3 Colour stability When tested in accordance with 7.13, there shall be no perceptible colour change between the exposed and unexposed halves of the tooth and the unexposed tooth. 5.3.4 Dimensional stability When tested in accordance with 7.14, the dimensional cha

45、nge of a tooth shall be within r 2 % of its original mesio-distal dimension. 6 Sampling The sample shall consist of six groups, each comprising sets of mandibular and maxillary anterior and posterior teeth (if available). For comparisons with the manufacturers shade guide, all available shades of an

46、terior teeth and five shades of available posterior teeth shades shall be included. Five mould sizes shall be included covering the range of mould sizes shown by the manufacturers mould chart. The teeth shall be representative of the physical dimensions of the brand and type. EN ISO 22112:20064 7 In

47、spection and test methods 7.1 Visual inspection Visually examine without magnification all the teeth in each set for compliance with the requirements given in 5.1.3 and 5.1.4. 7.2 Dimensions of teeth 7.2.1 Apparatus 7.2.1.1 Micrometer, accurate to r 0,01 mm and fitted with parallel steel face pieces

48、. 7.2.2 Procedure Measure the maximum mesio-distal dimension of each upper (l1, l5) and lower (l3, l7) set of teeth (see Clause 6) in the in-line plane for conformity to the mould chart dimensions (see 5.1.2). Measure the maximum mesio-distal (l2, l4) and cervico-incisal (h1, h2) dimensions of the u

49、pper and lower left central incisors (21, 31), and the overall facio-lingual (l6, l8) dimensions of the crowns of the upper and lower left first molars (26, 36), using a micrometer (7.2.1.1). See Figure 1 for these dimensions given in parentheses. The numerical tooth designations given in parentheses are in accordance with ISO 3950:1984. a) Dimensions of Type 1 teeth b) Dimensions of Type 2 teeth Figure 1 Dimensions of teeth to be measured 7.3 Comparison with shade guide Select a maxillary central incisor of all available anterior shades