SIST EN ISO 1567:2000
(Main)Dentistry - Denture base polymers (ISO 1567:1988)
Dentistry - Denture base polymers (ISO 1567:1988)
Zahnheilkunde - Prothesenkunststoffe (ISO 1567:1988)
1.1 In dieser Internationalen Norm werden die Prothesenkunststoffe klassifiziertund die Anforderungen festgelegt. Außerdem werden die Prüfverfahren zur Feststellung der Übereinstimmung mit diesen Anforderungen festgesetzt. Die vorliegende Internationale Norm bezieht sich auf die folgenden Prothesen- kunststoffe: a) Polyacrylsäureester; b) Substituierter Polyacrylsäureester; c)Polyvinylester; d) Polystyrol; e) mit Gummi veränderter Polymethacrylsäureester; f) Polycarbonate; g) Polysulfonate; h) Copolymerisate oder Mischungen der in a) bis g) aufgeführten Polymere.
Art dentaire - Polymeres pour base de protheses dentaires (ISO 1567:1988)
Dentistry - Denture base polymers (ISO 1567:1988)
General Information
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Dentistry - Denture base polymers (ISO 1567:1988)Zahnheilkunde - Prothesenkunststoffe (ISO 1567:1988)Art dentaire - Polymeres pour base de protheses dentaires (ISO 1567:1988)Dentistry - Denture base polymers (ISO 1567:1988)11.060.10Dental materialsICS:Ta slovenski standard je istoveten z:EN ISO 1567:1995SIST EN ISO 1567:2000en01-januar-2000SIST EN ISO 1567:2000SLOVENSKI
STANDARD
SIST EN ISO 1567:2000
SIST EN ISO 1567:2000
SIST EN ISO 1567:2000
SIST EN ISO 1567:2000
SIST EN ISO 1567:2000
INTERNATIONAL STANDARD Dentistry - Denture base polymers Art dentaire - Polymères pour base de prothèses dentaires IS0 1567 Second edition 1988-1 1-01 Reference number IS0 1567 : 1988 (E) SIST EN ISO 1567:2000
IS0 1567 : 1988 (E) Foreword IS0 (the International Organization for Standardization) is a worldwide federation of national standards bodies (IS0 member bodies). The work of preparing International Standards is normally carried out through IS0 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, govern- mental and non-governmental, in liaison with ISO, also take part in the work. IS0 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft International Standards adopted by the technical committees are circulated to the member bodies for approval before their acceptance as International Standards by the IS0 Council. They are approved in accordance with IS0 procedures requiring at least 75 % approval by the member bodies voting. International Standard IS0 1567 was prepared by Technical Committee ISO/TC 106, Dentistry. This second edition cancels and replaces the first edition (IS0 1567 : 1978). of which it constitutes a minor revision. 0 International Organization for Standardization, 1988 O Printed in Switzerland , I SIST EN ISO 1567:2000
IS0 1567 : 1988 (E) Introduction This revised edition of IS0 1567 has been prepared in the light of experience gained in the use of the first edition (IS0 1567-1978). The main changes are found in the test procedures and the calculation of water sorption and solubility, and in the test procedures for colour stability to light. A requirement for compatibility (bonding) to synthetic polymer teeth has also been included. Accordingly, most autopolymerized (type II polymers) and thermoplastic materials (type III) are required to have the follow- ing statement on a label : "WILL NOT BOND TO SYNTHETIC POLYMER TEETH". Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this International Standard, but it is recommended that reference should be made to ISO/TR 7405 when assessing possible biological or toxicological hazards. iii SIST EN ISO 1567:2000
SIST EN ISO 1567:2000
INTERNATIONAL STANDARD IS0 1567 : 1988 (E) Dentistry - Denture base polymers 1 Scope 1.1 This International Standard gives a classification of, and specifies requirements for, denture base polymers; it also specifies the test methods to be used to determine compliance with these requirements. This International Standard applies to the following denture base polymers : poly(acrylic acid esters); poly(substituted acrylic acid esters); poiy(viny1 esters); polystyrene; rubber modified poly(methacry1ic acid esters); polycarbonates; polysulfones; copolymers or mixtures of the polymers listed in a) to g). 1.2 Although this International Standard does not require manufacturers to declare details of the composition, attention is drawn to the fact that some national or international authorities require details to be provided to them. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the standards listed below. Members of IEC and IS0 maintain registers of currently valid International Standards. IS0 3336 : 1977, Dentistry - Synthetic resin teeth. ISOITR 7405 : 1984, Biological evaluation of dental materials. IS0 7491 : 1985, Dental materials - Determination of colour stability of dental polymeric materials. IS0 8601 : 1988, Data elements and interchange formats - Information interchange - Representation of dates and times. 3 Classification Denture base polymers covered by this International Standard are of the following types and classes : Type I : Heat-processed polymers - Class 1 : Powder and liquid - Class 2 : Plastic cake Type II : Autopolymerized polymers - Class 1 : Powder and liquid - Class 2 : Powder and liquid pour-type resins Type III : Thermoplastic blank or powder to form the denture base 4 Requirements 4.1 Composition See 1.2 for guidance on composition. 4.2 Liquid component 4.2.1 General The liquid shall consist essentially of monorneric material com- patible with the powder. It shall be clear and free of deposit or sediment when inspected (see 7.1). 4.2.2 Thermal stability The liquid shall show no thickening or discoloration when com- pared (see 7.11 with the original sample, after being maintained at 60 OC f 2 OC for 24 h in a closed container in the absence of light. 4.3 Solid components The solid or semi-solid components shall be free of extraneous material when inspected (see 7.1 1. 1 SIST EN ISO 1567:2000
IS0 1567 : 1988 (E) 4.4 Unprocessed resin, packing plasticity When type I, class 1 and 2 resins are tested in accordance with 7.2, at the initial and final packing times recommended by the manufacturer, they shall be capable of being intruded into at least two holes of the die (see figure 1) to a depth of not less than 0,5 mm (see 7.1). When prepared in accordance with the manufacturer’s instruc- tions, type 111 polymers shall produce a transverse specimen plate (see figure 3) with well defined edges. 4.5 Polymerized material 4.5.1 Quality When processed in accordance with the manufacturer’s instructions, the polymer shall produce a denture base com- plying with the requirements laid down in this International Standard. 4.5.2 Surface properties When processed in the manner and against materials recom- mended by the manufacturer, specimens, prepared in accord- ance with 7.3.2 and 7.4.1, shall have a smooth, hard, glossy surface. The test specimens for sorption and solubility shall retain their form without distortion after processing. When polished by conventional dental methods, the polymer shall present a smooth surface having a high gloss (see 7.1). 4.5.3 Biocompatibility See the Introduction (p. iii) for guidance on biocompatibility. 4.5.4 Colour Samples shall be prepared in accordance with 7.4.1 and in- spected in accordance with 7.1. Coloured processed polymer shall be of the colour stated by the manufacturer and shall match the manufacturer’s shade guide, if supplied. It shall be translucent (see 4.5.5 and 7.4.2) and evenly pigmented or mottled (fibred). Clear processed polymer shall be clear and colourless. If the manufacturer‘s instructions (see 8.3) allow the use of separating media other than tin foil, the colour and general appearance of the surface of the polymer processed against such media and polished by conventional dental methods shall not differ from that of the polymer processed against tin foil and polished in a similar manner. 4.5.5 Translucency When tested in accordance with 7.4.2, the illuminated opaque disc shall be visible from the opposite side of the test specimen plate (see 7.1). 4.5.6 Freedom from porosity When prepared in accordance with 7.4.3, specimen strips shall not show voids (see 7.1) when viewed without magnification (7.4.4). 4.5.7 Sorption When the processed polymer is tested in accordance with 7.3, the increase in mass per unit volume (water sorption) shall not exceed 32 pg/mm3for either type I, type II or type III materials. 4.5.8 Solubility When the processed polymer is tested in accordance with 7.3, the loss in mass per unit volume (soluble matter) shall not exceed 1,6 pg/mm3 for type I and type III materials, and shall not exceed 8,O pg/mm3 for type II materials. 4.5.9 Transverse deflection When determined in accordance with 7.4.5, the transverse deflection of the processed polymer shall meet the requirements specified in table 1 when tested in water at 37 OC f 1 OC. The transverse breaking force shall be not less than 55 N for type I and type III materials and not less than 50 N for type II materials. Table 1 - Transverse deflection Deflection min. I max. Force increment N I Between 15 and 35 1 FIT ~~ I Between15and 50 I2 151 4.5.10 Colour stability Test specimens shall not show (see 7.1) more than a slight change in colour, perceptible with difficulty, when tested in accordance with 7.5. 4.5.11 Bonding to synthetic polymer teeth For denture base polymers intended for use with synthetic polymer teeth, either - the polymer shall be capable of bonding to polymer teeth complying with the requirements of IS0 3336, or - the outer package and containers shall be marked with a statement of the inability to bond [see 8.2.1 I) and 8.2.2 I)], or - the outer package and containers shall contain infor- mation about special treatments necessary to achieve ade- quate bonding [see 8.2.1 mi and 8.2.2 m)]. 5 Sampling The test sample shall consist of a retail package or packages, containing sufficient material to carry out the specified tests, plus an allowance for any necessary repetition of the tests. If more than one package is required, the material in both shall be from the same batch. 2 SIST EN ISO 1567:2000
IS0 1567 : 1988 (E) 6 Preparation of test specimens 6.1 Ambient conditions The test specimens shall be prepared at 23 OC I 2 OC and at a relative humidity of 50 % f 10 %, except where otherwise specified by the manufacturer. 7.3 Water sorption and solubility 7.3.1 Apparatus and materials 7.3.1.1 Desiccator. 7.3.1.2 Rack to keep the specimens parallel and separated. 6.2 Procedure Prepare the specimens from resins proportioned, mixed, packed and processed in accordance with the manufacturer’s instructions (see 8.3). 7 Test methods 7.1 Inspection requirements Visually inspect without magnification the test specimens to determine compliance with the requirements laid down in 4.2, 4.3, 4.4, 4.5.2, 4.5.4, 4.5.5, 4.5.6, 4.5.10 and clause 8. Inspect for colour (see 4.5.4) and colour stability (see 4.5.10) in ac- cordance with IS0 7491. 7.2 Packing plasticity 7.2.1 Apparatus 7.2.1.1 Perforated brass die, having the dimensions shown in figure 1, with perforations having a diameter of 0,75 mm f 0,05 mm. 7.2.1.2 Glass plate, 60mm f 5mm x 60mm f 5mm x 5mm I 1 mm. 7.2.1.3 Weight, capable of applying a force of 50 N. 7.2.2 Test conditions The perforated brass die (7.2.1.1) and glass plate (7.2.1.2) shall be maintained at ambient temperature except where otherwise specified by the manufacturer. 7.2.3 Procedure Prepare a sample of resin with a mass of 8 g to 10 g in accord- ance with the manufacturer’s instructions. Immediately prior to the recommended initial packing time [see 8.3~11, shape to a thickness of approximately 5 mm, place on the upper surface of the perforated brass die and cover with a sheet of regenerated cellulose or polyethylene film. At the recommended packing time, carefully place the glass plate and weight (7.2.1.3) on top. After 10 min, remove the weight. When the material is firm, record the depth of penetration with a precision of 0,2 mm by measuring from the lower surface of the brass die to the in- truded polymer and subtracting this from the thickness of the brass die. Repeat the test at the maximum working time recom- mended by the manufacturer [see 8.3~11. Report the number of holes penetrated to a depth of not less than 0.5 mm. 7.3.1.3 Oven or incubator, capable of being maintained at 37% f 1 OC. 7.3.1.4 Stainless steel mould and cover, having the dimensions shown in figure 2, mounted in gypsum in separate halves of a denture flask. 7.3.1.5 Sheet of polyester film, having a thickness of 50 pm k 25 pm and a diameter of 80 mm. 7.3.1.6 Silica gel, freshly dried for 5 h at 130 OC. 7.3.1.7 Water, prepared in one of the following ways : a) by multiple distillation; b) c) by distillation followed by deionization; by distillation followed by reverse osmosis. 7.3.2 Preparation of test specimen discs Three specimens shall be prepared. Mix the resin and pack the mixture into the mould (7.3.1.4) with the polyester film (7.3.1.5) against the steel cover of the mould. Process the mixture in accordance with the manufacturer’s in- structions, but retain the polyester film during the processing cycle. Check to ensure that each specimen disc has a diameter of 50 mm I 1 mm and a thickness of 0.5 mm I 0,l m
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