SANS 15854-2008 Dentistry - Casting and baseplate waxes《牙科 铸型蜡和假牙托塑性材料》.pdf

1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA

2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any

3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ISBN 978-0-626-21432-6 SANS 15854:2008Edition 1 ISO 15854:2005Edition 1 SOUTH AFRICAN NATIONAL STANDARD Dentistry Casting and baseplate waxes This nation

4、al standard is the identical implementation of ISO 15854:2005 and is adopted with the permission of the International Organization for Standardization. Published by SABS Standards Division 1 Dr Lategan Road Groenkloof Private Bag X191 Pretoria 0001Tel: +27 12 428 7911 Fax: +27 12 344 1568 www.sabs.c

5、o.za SABS SANS 15854:2008 Edition 1 ISO 15854:2005 Edition 1 Table of changes Change No. Date Scope National foreword This South African standard was approved by National Committee SABS SC 106B, Dental equipment and materials Dental materials, in accordance with procedures of the SABS Standards Divi

6、sion, in compliance with annex 3 of the WTO/TBT agreement. This SANS document was published in September 2008. Reference numberISO 15854:2005(E)ISO 2005INTERNATIONAL STANDARD ISO15854First edition2005-07-15Dentistry Casting and baseplate waxesArt dentaire Cires pour coule et pour plaque de base SANS

7、 15854:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 15854:2005(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited u

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12、blished in Switzerland ii ISO 2005 All rights reservedSANS 15854:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 15854:2005(E) ISO 2005 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope 1 2 Normative references 1

13、 3 Terms and definitions .1 4 Classification2 5 Requirements.2 5.1 Appearance 2 5.2 Flow.2 5.3 Behaviour on trimming .2 5.4 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 colour

14、ing 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 Sampling.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 tr

15、imming .8 8.4 Behaviour on softening (Type 1)8 8.5 Appearance after flaming (Type 2).8 8.6 Behaviour on softening (Type 2)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

16、 9.1 Marking .11 9.2 Packaging .11 Bibliography 12 SANS 15854:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 15854:2005(E) iv ISO 2005 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwid

17、e 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 right to be represented on that

18、 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. International Standards are drafted in ac

19、cordance 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 an International Standard req

20、uires 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 15854 was prepared by Techni

21、cal 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. SANS 15854:2008This s tandard may only be used and printed by approved subscription and freemailing clients

22、of the SABS .ISO 15854:2005(E) ISO 2005 All rights reserved vIntroduction This International Standard does not include specific and quantitative requirements for freedom from biological hazards. It is recommended that, in assessing possible biological or toxicological hazards, reference be made to I

23、SO 7405 and ISO 10993-1 (see Bibliography). SANS 15854:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .SANS 15854:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .INTERNATIONAL

24、STANDARD ISO 15854:2005(E) ISO 2005 All rights reserved 1Dentistry Casting and baseplate waxes 1 Scope This International 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

25、with the test methods to be employed to determine compliance with these requirements. 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

26、the referenced document (including any amendments) applies. ISO 1942-2, Dental vocabulary Part 2: Dental materials 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 inte

27、rchange Representation of dates and times 3 Terms and definitions For the purposes of this document, the terms and 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-w

28、ax” procedure 3.2 baseplate wax mouldable material primarily for shaping patterns that will be duplicated in denture 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

29、. SANS 15854:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 15854:2005(E) 2 ISO 2005 All rights reserved4 Classification Dental waxes covered by this International Standard are classified according to the flow characteristics that re

30、present 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 uniform size, of smooth texture and fr

31、ee 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 Class 1 Class 2 Class 1 Class 2 Class 3 Te

32、mperature 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 shall be capable of being trimmed without

33、 chipping, flaking or tearing when tested in accordance with 8.3. SANS 15854:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 15854:2005(E) ISO 2005 All rights reserved 35.4 Behaviour on softening (Type 1) The wax shall soften without

34、flaking or crumbling and shall cohere readily when tested in accordance with 8.4. 5.5 Appearance after flaming (Type 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 sh

35、all be mouldable without breaking or laminating when tested in accordance with 8.6. 5.7 Residue on artificial teeth (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 sh

36、all neither separate from the wax nor impregnate the gypsum mould when tested in accordance with 8.7. 5.9 Adhesion 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

37、 contact with either wax or paper. Where separating paper is used, the wax and paper surfaces shall separate cleanly 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

38、.9, shall be no greater than 0,1 %. If the manufacturer states a value for the residue on ignition, the solid residue 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

39、. 6 Sampling The amount of material procured for testing shall be at least 250 g for Type 1, or 500 g for Type 2, 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 a

40、n ambient temperature of (23 2) C. SANS 15854:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 15854:2005(E) 4 ISO 2005 All rights reserved7.2 Apparatus function verification All accessories, instruments and equipment shall be examined

41、 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 normal visual acuity and without magnific

42、ation. 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 the one shown in Figure 1, consistin

43、g 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 or better, and rigidly supported (opti

44、onal); 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 (3) by the shaft (2). The diameter of

45、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 or porcelain pan with handle similar

46、 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. SANS 15854:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 15854:2005(E) ISO 2005 All rights reserved 5Key

47、 1 weight 2 shaft 3 brass plate 4 gauge 5 locking screw Figure 1 Flow-testing instrument SANS 15854:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 15854:2005(E) 6 ISO 2005 All rights reservedFigure 2 Example of pouring pan Dimensions

48、 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

49、the axes of the holes perpendicular to the surface of the plate. The sides of the holes shall be polished such that the surface roughness (Ra) is less than 0,3 m. 8.2.1.6 Glass slab As a base for the mould, use a glass slab, approximately 152 mm long, 76 mm wide and 19 mm thick. SANS 15854:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 15854:200