EN ISO 15854-2005 en Dentistry - Casting and baseplate waxes《牙科学 铸型蜡和假牙托蜡 ISO 15854-2005 代替EN ISO 12163-2000 和 EN ISO 1567-2000》.pdf

1、BRITISH STANDARDBS EN ISO 15854:2005Dentistry Casting and baseplate waxesThe European Standard EN ISO 15854:2005 has the status of a British StandardICS 11.060.10g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g

2、44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 15854:2005This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 December 2005 BSI 30 December 2005ISBN 0 580 47383 XNational forewordThis British Standard is the official En

3、glish language version of EN ISO 15854:2005. It is identical with ISO 15854:2005. It supersedes both BS EN ISO 12163.2000 and BS EN ISO 1561:1998, which are withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/106, Dentistry, to Subcommittee CH/106/2, Prosthodont

4、ic materials, 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 Catalo

5、gue under 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 corre

6、ct application. 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

7、; monitor 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 v, a blank page, pages 1 to 12, an inside back cover

8、and a back cover.The BSI copyright notice displayed in this document indicates when the document was last issued.Amendments issued since publicationAmd. No. Date CommentsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 15854July 2005ICS 11.060.10 Supersedes EN ISO 12163:2000, EN ISO 1567:2000 E

9、nglish VersionDentistry - Casting and baseplate waxes (ISO 15854:2005)Art dentaire - Cires pour coule et pour plaque de base(ISO 15854:2005)Zahnheilkunde - Guss- und Basisplattenwachse (ISO15854:2005)This European Standard was approved by CEN on 1 July 2005.CEN members are bound to comply with the C

10、EN/CENELEC Internal Regulations which stipulate 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

11、any CEN member.This European Standard exists in 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

12、 members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and

13、United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2005 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 15854:20

14、05: EForeword This document (EN ISO 15854:2005) 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

15、 publication of an identical text or by endorsement, at the latest by January 2006, and conflicting national standards shall be withdrawn at the latest by January 2006. This document supersedes EN ISO 12163:2000 and EN ISO 1567:2000. According to the CEN/CENELEC Internal Regulations, the national st

16、andards organizations 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,

17、 Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 15854:2005 has been approved by CEN as EN ISO 15854:2005 without any modifications. EN ISO 15854:2005Reference numberISO 15854:2005(E)INTERNATIONAL STANDARD ISO15854First edition2005-07-15Dentistry

18、 Casting and baseplate waxesArt dentaire Cires pour coule et pour plaque de base EN ISO 15854:2005ii iiiContents Page Foreword iv Introduction v 1 Scope 1 2 Normative references 1 3 Terms and definitions .1 4 Classification2 5 Requirements.2 5.1 Appearance 2 5.2 Flow.2 5.3 Behaviour on trimming .2 5

19、.4 Behaviour on softening (Type 1)3 5.5 Appearance after flaming (Type 2).3 5.6 Behaviour on softening (Type 2)3 5.7 Residue on artificial teeth (Type 2) 3 5.8 Behaviour of colouring material (Type 2)3 5.9 Adhesion on storage (Type 2) 3 5.10 Residue on ignition (Type 1).3 5.11 Biocompatibility.3 6 S

20、ampling.3 7 Test methods General 3 7.1 Ambient temperature.3 7.2 Apparatus function verification4 8 Test methods Specific 4 8.1 Visual inspection .4 8.2 Flow.4 8.3 Behaviour on trimming .8 8.4 Behaviour on softening (Type 1)8 8.5 Appearance after flaming (Type 2).8 8.6 Behaviour on softening (Type 2

21、)8 8.7 Residue on artificial teeth and behaviour of colouring material (Type 2)8 8.8 Adhesion on storage (Type 2) 10 8.9 Residue on ignition (Type 1).10 9 Marking and packaging.11 9.1 Marking .11 9.2 Packaging .11 Bibliography 12 EN ISO 15854:2005iv Foreword ISO (the International Organization for S

22、tandardization) 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 ri

23、ght 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. Internationa

24、l 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 Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as

25、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 of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO

26、 15854 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials. This first edition cancels and replaces ISO 1561:1995 and ISO 12163:1999, which have been technically revised. EN ISO 15854:2005vIntroduction This International Standard does not include spe

27、cific and quantitative requirements for freedom from biological hazards. It is recommended that, in assessing possible biological or toxicological hazards, reference be made to ISO 7405 and ISO 10993-1 (see Bibliography). EN ISO 15854:2005blank1Dentistry Casting and baseplate waxes 1 Scope This Inte

28、rnational Standard is applicable to dental casting wax and to dental baseplate wax. It specifies the classification of, and requirements for, dental casting wax and baseplate wax together with the test methods to be employed to determine compliance with these requirements. 2 Normative references The

29、 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 1942-2, Dental vocabulary Part 2: Dental materia

30、ls ISO 3336, Dentistry Synthetic polymer teeth1)ISO 4824, Dentistry Ceramic denture teeth1)ISO 6873, Dental gypsum products ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times 3 Terms and definitions For the purposes of this document, the terms a

31、nd definitions given in ISO 1942-2 and the following apply. 3.1 casting wax mouldable material primarily for shaping patterns in the production of fixed cast restorations using the “lost-wax” procedure 3.2 baseplate wax mouldable material primarily for shaping patterns that will be duplicated in den

32、ture base polymers, and for forming occlusion rims and other patterns 1) ISO 3336 and ISO 4824 are to be combined and revised as ISO 22112, Dentistry Artificial teeth for dental prostheses. EN ISO 15854:20052 4 Classification Dental waxes covered by this International Standard are classified accordi

33、ng to the flow characteristics that represent their hardness, as follows: a) Type 1 (casting wax): 1) Class 1 Soft 2) Class 2 Hard b) Type 2 (baseplate wax): 1) Class 1 Soft 2) Class 2 Hard 3) Class 3 Extra hard 5 Requirements 5.1 Appearance The wax shall be uniform in colour, supplied in pieces of

34、uniform size, of smooth texture and free of foreign materials. Test in accordance with 8.1. 5.2 Flow The samples of the wax when tested in accordance with 8.2 shall have flow properties complying with the requirements in Table 1. Table 1 Flow requirements Type 1 Casting wax Type 2 Baseplate wax Clas

35、s 1 Class 2 Class 1 Class 2 Class 3 Temperature Min. Max. Min. Max. Min. Max. Min. Max. Min. Max. C % % % % % % % % % % 23,0 0,1 1,0 0,6 0,2 30,0 0,1 1,0 37,0 0,1 1,0 5,0 90,0 10,0 1,2 40,0 0,1 50,0 20,0 45,0 0,1 70,0 90,0 70,0 90,0 50,0 90,0 5,0 50,0 Undefined. 5.3 Behaviour on trimming The wax sha

36、ll be capable of being trimmed without chipping, flaking or tearing when tested in accordance with 8.3. EN ISO 15854:200535.4 Behaviour on softening (Type 1) The wax shall soften without flaking or crumbling and shall cohere readily when tested in accordance with 8.4. 5.5 Appearance after flaming (T

37、ype 2) The wax shall present a smooth glossy surface when tested in accordance with 8.5. 5.6 Behaviour on softening (Type 2) The wax shall soften without becoming sticky or crumbly and shall be mouldable without breaking or laminating when tested in accordance with 8.6. 5.7 Residue on artificial tee

38、th (Type 2) The wax shall not leave a residue on either ceramic or plastic teeth when tested in accordance with 8.7. 5.8 Behaviour of colouring material (Type 2) The colouring material shall neither separate from the wax nor impregnate the gypsum mould when tested in accordance with 8.7. 5.9 Adhesio

39、n on storage (Type 2) Self-adhesion during storage of the wax shall be such that when tested in accordance with 8.8, there shall be no evidence of damage to wax surfaces that have been in contact with either wax or paper. Where separating paper is used, the wax and paper surfaces shall separate clea

40、nly and readily. 5.10 Residue on ignition (Type 1) If the manufacturer does not state a value for the residue on ignition, the solid residue of the wax, as determined in accordance with 8.9, shall be no greater than 0,1 %. If the manufacturer states a value for the residue on ignition, the solid res

41、idue of the wax, as determined in accordance with 8.9, shall not differ by more than 20 % from that value. 5.11 Biocompatibility See ISO 7405 and ISO 10993-1 for guidance on compatibility. 6 Sampling The amount of material procured for testing shall be at least 250 g for Type 1, or 500 g for Type 2,

42、 and from one batch. 7 Test methods General 7.1 Ambient temperature Unless otherwise specified in this International Standard, all specimen preparation and testing shall be conducted at an ambient temperature of (23 2) C. EN ISO 15854:20054 7.2 Apparatus function verification All accessories, instru

43、ments and equipment shall be examined before use to ensure that they are in acceptable working order, appropriately calibrated and complying with specifications stated for them in this International Standard. 8 Test methods Specific 8.1 Visual inspection Carry out visual inspection at nominally norm

44、al visual acuity and without magnification. 8.2 Flow 8.2.1 Apparatus 8.2.1.1 Micrometer screw gauge For measuring specimen length, use a micrometer screw gauge with a range of at least 10 mm, being accurate to 0,005 mm or better. 8.2.1.2 Flow-testing instrument Use a flow-testing instrument, such as

45、 the one shown in Figure 1, consisting of the following components: metallic cylindrical weight (item 1 in Figure 1); plastic or hard rubber shaft (item 2 in Figure 1); brass plate (item 3 in Figure 1); measuring dial gauge (item 4 in Figure 1), with a range of at least 10 mm, accurate to 0,005 mm o

46、r better, and rigidly supported (optional); locking screw (item 5 in Figure 1) (optional). The total mass of the components of items 1, 2 and 3 shall be such as to provide an axial compressive force of (19,6 0,1) N. The weight (1) shall be separated a minimum distance of 76 mm from the brass plate (

47、3) by the shaft (2). The diameter of the brass plate (3) shall be no less than 50 mm and the thickness no greater than 6,5 mm. The optional dial gauge (4) and locking screw (5) may replace the micrometer screw gauge for direct measurement (8.2.3). 8.2.1.3 Pouring pan For melting the wax, use a metal

48、 or porcelain pan with handle similar to the example shown in Figure 2. 8.2.1.4 Infrared lamp For heating the wax, use an infrared lamp with nominal power of 250 W. EN ISO 15854:20055Key 1 weight 2 shaft 3 brass plate 4 gauge 5 locking screw Figure 1 Flow-testing instrument EN ISO 15854:20056 Figure

49、 2 Example of pouring pan Dimensions in millimetres Figure 3 Mould for forming flow specimens 8.2.1.5 Mould For forming the specimens, use a mould as shown in Figure 3, consisting of a flat stainless steel plate, (6,0 0,1) mm thick, with parallel top and bottom surfaces. The plate shall have four holes (10,0 0,1) mm in diameter, with the axes of the holes perpendicular to the surface of the plate. The sides of the holes shall be polished such that the