SIST EN 23107:2000
(Main)Dental zinc oxide/eugenol cements and zinc oxide non-eugenol cements (ISO 3107:1988)
Dental zinc oxide/eugenol cements and zinc oxide non-eugenol cements (ISO 3107:1988)
Zahnärztliche Zinkoxid-Eugenol- und Zinkoxid-Noneugenol-Zemente (ISO 3107:1988)
Ciments dentaires a base d'oxyde de zinc-eugénol et ciments dentaires a base d'oxyde de zinc sans eugénol (ISO 3107:1988)
Dental zinc oxide/eugenol cements and zinc oxide non-eugenol cements (ISO 3107:1988)
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Dental zinc oxide/eugenol cements and zinc oxide non-eugenol cements (ISO 3107:1988)Zahnärztliche Zinkoxid-Eugenol- und Zinkoxid-Noneugenol-Zemente (ISO 3107:1988)Ciments dentaires a base d'oxyde de zinc-eugénol et ciments dentaires a base d'oxyde de zinc sans eugénol (ISO 3107:1988)Dental zinc oxide/eugenol cements and zinc oxide non-eugenol cements (ISO 3107:1988)11.060.10Dental materialsICS:Ta slovenski standard je istoveten z:EN 23107:1991SIST EN 23107:2000en01-januar-2000SIST EN 23107:2000SLOVENSKI
STANDARD
SIST EN 23107:2000
SIST EN 23107:2000
SIST EN 23107:2000
INTERNATIONAL STANDARD INTERNATIONAL ORGANIZATION FOR STANDARDIZATION ORGANISATION INTERNATIONALE DE NORMALISATION MEXAYHAPOAHAR OPTAHM3A~Mfi l-l0 CTAH,lJAPTM3A~MM Dental zinc oxide/eugenol cements and zinc Oxide non-eugenol cements Ciments dentaires & base d’oxyde de zinc-eughol et ciments dentaires 4 base d’oxyde de iinc sans eughnol Second edition 1988-11-01 Reference number ISO 3107: 1988 (E) SIST EN 23107:2000
ISO 3107:1988 (EI 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 carried out through ISO technical committees. Esch 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. ISO 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 ISO Council. They are approved in accordance with ISO procedures requiring at least 75 % approval by the member bodies voting. International Standard ISO 3107 was prepared by Technical Committee ISO/TC 106, Dentistry. This second edition cancels and replaces the first editions of ISO 3106 : 1974 and ISO 3107 : 1974. Users should note that all International Standards undergo revision from time to time and that any reference made herein to any other International Standard implies its latest edition, unless othewise stated. 0 International Organkation for Standardkation, 1988 0 Printed in Switzerland SIST EN 23107:2000
INTERNATIONAL STANDARD ISO 3107 : 1988 (E) Dental zinc oxide/eugenol cements and zinc Oxide non-eugenol cements 0 Introduction Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this International Standard, but it is recommended that in assessing possible biological or toxicological hazards, reference should be made to ISO/TR 7405. 1 Scope This International Standard specifies requirements and test methods for zinc oxide/eugenol or zinc oxide/non-eugenol cements supplied as two separate components which may be either powder/liquid or paste/paste and which are suitable for use in the oral cavity. These non-aqueous cements may contain eugenol or an aromatic Oil, compounds capable of reacting with zinc Oxide such as accelerators, and gums, resins and inert inorganic fillers. 2 Field of application This International Standard covers commercially manufactured zinc oxide/eugenol and modified zinc oxide/eugenol cements suitable for use in restorative dentistry for temporary cemen- tation, for permanent cementation, such as temporary resto- rations and bases, and as cavity liners. This International Stan- dard also covers non-eugenol cements containing zinc Oxide and aromatic oils suitable for temporary cementation. 3 References ISO 2590, General method for the determination of arsenic - Silver die th yldithiocarbama te pho tome tric me thod. ISOITR 7405, Biological evaluation of dental materials. 4 Classif ication For the purposes of this International Standard, zinc oxide/eugenol cements are classified, according to their intended use in restorative dentistry, into the following types. Type 1: For temporary cementation - setting and non-setting Class 1 : Powder and liquid Class 2A: Setting Paste and Paste containing eugenol Class 2B : Setting Paste and Paste not containing eugenol Class 3: Non-setting Paste and Paste Type II: For permanent cementation Class 1 : Powder and liquid Type Ill: For temporary restorations and bases Class 1 : Powder and liquid Class 2: Paste and Paste Type IV: For cavity liners Class 1 : Powder and liquid Class 2: Setting Paste and Paste Zinc oxide/non-eugenol cements covered by this International Standard are indicated as such. 5 Requirements 5.1 Material The components of the material, when mixed in accordance with the manufacturer’s instructions, shall produce a material with characteristics suitable for its intended use within a given time. 5.2 Components 5.2.1 Liquid The liquid shall be clear, colourless or have only a slight amber tinge, and shall be free from suspended matter or deposits. 5.2.2 Powder The powder shall be free of extraneous materials. When coloured, the Pigment shall be uniformly dispersed throughout the powder. SIST EN 23107:2000
ISO 3107 : 1988 EI 5.2.3 Pastes The unit package of pastes shall consist of two collapsible tubes or other Containers, one containing the zinc Oxide Paste with or without modifiers, and the other containing eugenol or non-eugenol Paste with or without modifiers. These pastes shall be homogeneous and free from extraneous matter. 5.3 Performance requirements When tested in accordance with the appropriate test methods specified in clause 7, cements shall comply with the perfor- mance requirements specified in the table. 5.4 Biocompatibility See clause 0 for use of ISO/TR 7405. The total arsenic content of the cement shall not exceed the limit specified in the table, when tested in accordance with 7.6. 5.5 Manufacturer’s instructions Instructions for guidance of the user in proportioning, mixing and manipulation shall accompany each unit package. The following details shall be included: a) the recommended temperature and humidity for mix- ing, and condition and type of mixing surface; b) the component ratio recommended for each specific application ; c) the rate of incorporation of the components; d) the time of mixing ; e) the working time after the end of mixing ; f) the setting time, where appropriate. 6 Sampling and inspection 6.1 Procurement The method of procurement shall be the subject of an agree- ment between the manufacturer and test authority, and shall be recorded. 6.2 Sampling A Sample drawn from one batch shall provide sufficient powder and liquid or the appropriate pastes to complete all the specif ied tests. 6.3 Inspection Compliance with the requirements specified in 5.2.1, 5.2.2, 5.2.3, 5.5 and clause 8 shall be determined by visual inspection. 7 Test methods 7.1 Preparation of test specimens 7.1.1 Ambient conditions Carry out all mixing of the cement for the preparation of test specimens at a temperature of 23 OC & 1 OC and a relative humidity of 50 % + 2 %. Type and class Type I-class 1 Type 1-class 2A Type 1-class 2B Type 1-class 3 Type Il-class 1 Type Ill-class 1 Type Ill-class 2 Type IV-class 1 Type IV-class 2 ’ NA = not applicable Table - Performance requirements 1 Setting time Compressive Disintegration Film Acid-soluble at 37 OC strength at 24 h after 24 h thickness arsenic content min MPa % bnlm) Pm mg/ kg (ppm) 4 min. max. min. max. max. max. max. 4 10 35 2,5 25 2 4 I 10 35 2,5 25 2 4 IO 35 2,5 25 2 Penetration at 1 h NA* NA* NA* 25 2 4 10 35 115 25 2 3 10 25 1,5 NA* 2 3 10 25 1,5 NA* 2 4 10 5 115 NA* 2 4 10 5 1,5 NA* 2 SIST EN 23107:2000
ISO3107:1988 (EI 7.12 Apparatus for mixing 7.2.2 Procedure Condition the metal block (7.2.1.4) and indentor needle (7.2.1.2) in the oven (7.2.1.1) at 37 OC Ifr 1 OC. 7.1.2.1 Smooth glass slab, approximately 150 mm x 75 mm x 20 mm. If a mixing pad is supplied by the manufac- turer, it may be used. Place the metal mould (7.2.1.31, conditioned at 23 OC $r 1 OC, on the flat glass plate (7.2.1.5) and fill to a level surface with the cement mixed in accordance with the manufacturer’s instruc- tions. 7.1.2.2 Rigid spatula, inert to the cement. All apparatus used for mixing and testing shall be kept clean, dry and free from particles of hardened cement. After 120 s + IO s for type Ill-class 1, or 180 s + 10 s for type 1-classes 1, 2A and 2B, type Il-class 1 and type IV- classes 1 and 2 from the Start of mixing, transfer the specimen to the oven for testing. 7.1.3 Conditioning Before the Start of mixing, condition the test samples and ap- paratus at the ambient conditions specified in 7.1 .l, for at least 1 h, except where otherwise stated by the manufacturer. As soon as possible after placing the specimens in the oven, carefully lower the indentor needle vertically onto the surface of the cement. Make indentations at 15 s intervals until the time of setting has been reached. Maintain the needle in a clean condi- tion between indentations. 7.1.4 Procedure for mixing Place the components on the specified by the manufacturer. mixing surface in the Record the setting time as the period of time which elapses from the Start of mixing to the time when the needle fails to penetrate completely the 2 mm depth of cement. This penetra- tion tan be confirmed by holding the specimen up to the light and examining visually. Repeat this test once. If the material is supplied as a paste/paste System, use a com- ponent ratio in grams per gram or in measured lengths, in ac- cordante with the manufacturer’s instructions, producing a minimum of 0,75 ml of mixed material. NOTE - Type I-class 3 is non-setting. To verify this property, use the 100 g k 0,5 g indentor needle and test every 15 min for 1 h. Complete Penetration shall be obtained for each trial. Completely mix the compo manufacturer’s instructions. nents in accordance with the 7.2.3 Expression of results 7.2 Determination of setting time Calcu late the average of result to the nearest 15 s. two determinations and record 7.2.1 Apparatus 7.2.1.1 Oven or cabinet, capable of being maintained at a temperature of 37 OC + 1 OC and a relative humidity from 95 % to 100 %. 7.3 Determination of compressive strength 7.3.1 Apparatus 7.2.1.2 Indentor needle, of mass 400 g + 2 g and having a flat end of diameter 1,O mm + 0,l mm. The needle tip shall be cylindrical for a distance of approximately 5,0 mm. The needle end shall be plane and at right angles to the axis of the rod. This indentor needle shall be used for testing type 1-class 1, type II- class 1, type Ill-class 1 and type IV-class 1. 7.3.1.1 Oven or cabinet, as specified in 7.2.1 .l. 7.3.1.2 Five Split moulds and plates, such as shown in figure 2, 6 mm high and with an internal diameter of 4 mm, made of stainless steel or other material which is not attacked or corroded by the cement. A similar indentor needle of mass 100 g + 0,5 g and having a flat end of diameter 2,0 mm + 0,l mm shall be used for type I- classes 2A and 28, and type IV-class 2. 7.3.1.3
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