1、January 2008DEUTSCHE NORM English price group 13No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.060.10!$Kh“1409269w
2、ww.din.deDDIN EN ISO 9917-1Dentistry Water-based cements Part 1: Powder/liquid acid-base cements (ISO 9917-1:2007)English version of DIN EN ISO 9917-1:2008-01Zahnheilkunde Wasserhrtende Zemente Teil 1: Zemente, die beim Vermischen von Pulver und Flssigkeit ber eineSure-Base-Reaktion abbinden (ISO 99
3、17-1:2007)Englische Fassung DIN EN ISO 9917-1:2008-01SupersedesDIN EN ISO 9917-1:2004-04www.beuth.deDocument comprises 28 pagesDIN EN ISO 9917-1:2008-01 2 National foreword This standard has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC
4、55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Dental (Dentistry Standards Committee), Technical Committee NA 014-00-01 AA Fllungswerkstoffe. The DIN Standards corresponding to the International Standards referred to in the
5、 EN are as follows: ISO 3696 DIN ISO 3696 ISO 7405 DIN EN ISO 7405 ISO 7491 DIN EN ISO 7491 ISO 10993-1 DIN EN ISO 10993-1 Amendments This standard differs from DIN EN ISO 9917-1:2004-04 as follows: a) The standard has been editorially revised. Previous editions DIN 13902: 1972-12 DIN 13903: 1972-12
6、 DIN 13916: 1974-12 DIN 13918: 1977-01 DIN 13944: 1991-05 DIN EN 29917: 1994-06 DIN EN ISO 9917-1: 2004-04 National Annex NA (informative) Bibliography DIN ISO 3696, Water for analytical laboratory use Specification and test methods DIN EN ISO 7405, Dentistry Preclinical evaluation of biocompatibili
7、ty of medical devices used in dentistry Test methods for dental materials DIN EN ISO 7491, Dental materials Determination of colour stability DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system EUROPEAN STANDARD NORME EUROPENNE
8、EUROPISCHE NORM EN ISO 9917-1 October 2007 ICS 11.060.10 Supersedes EN ISO 9917-1:2003 English Version Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements (ISO 9917-1:2007) Art dentaire - Ciments base deau - Partie 1: Ciments acido-basiques liquides/en poudre (ISO 9917-1:2007)
9、Zahnheilkunde - Wasserhrtende Zemente - Teil 1: Zemente, die beim Vermischen von Pulver und Flssigkeit ber eine Sure-Base-Reaktion abbinden (ISO 9917-1:2007) This European Standard was approved by CEN on 8 October 2007. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which
10、stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member. This European Stan
11、dard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national st
12、andards bodies of Austria, Belgium, Bulgaria, 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 K
13、ingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2007 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 9917-1:200
14、7: EContents Page EN ISO 9917-1:2007 (E) Foreword 3 1 Scope .4 2 Normative references .4 3 Terms and definitions 4 4 Classification 5 5 Material 5 6 Preparation of test specimens 6 7 Sampling .6 8 Requirements 6 9 Packaging, marking and information to be supplied by manufacturer 7 Annex A (normative
15、) Determination of net setting time 10 Annex B (informative) Chemical composition and applications of dental cements .12 Annex D (normative) Determination of compressive strength .15 Annex E (normative) Determination of acid erosion 17 Annex G (normative) Determination of acid-soluble arsenic and le
16、ad contents 23 Annex H (normative) Determination of radio-opacity 24 Bibliography .26 Annex F (normative) Determination of optical properties (polyalkenoate restorative cements only).20 Annex C (normative) Determination of film thickness (luting cements only) .13 2 DIN EN ISO 9917-1:2008-01 Foreword
17、 3 This document (EN ISO 9917-1:2007) 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 publicatio
18、n of an identical text or by endorsement, at the latest by April 2008, and conflicting national standards shall be withdrawn at the latest by April 2008. This document supersedes EN ISO 9917-1:2003. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the follow
19、ing countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slove
20、nia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 9917-1:2007 has been approved by CEN as a EN ISO 9917-1:2007 without any modification. EN ISO 9917-1:2007 (E) DIN EN ISO 9917-1:2008-01 1 Scope This part of ISO 9917 specifies requirements and test methods for
21、 powder/liquid acid-base dental cements intended for permanent cementation, lining and restoration. This part of ISO 9917 is applicable to both hand-mixed and capsulated cements for mechanical mixing. This part of ISO 9917 specifies limits for each of the properties according to whether the cement i
22、s intended for use as a luting agent, a base or liner or as a restorative material. This part of ISO 9917 is not intended to address resin-modified water-based cements. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated referen
23、ces, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 2590, General method for the determination of arsenic Silver diethyldithiocarbamate photometric method ISO 3665:1996, Photography Intra-oral dental radio
24、graphic film Specification ISO 3696:1987, Water for analytical laboratory use Specification and test methods ISO 7491, Dental materials Determination of colour stability 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 mixing time that part of
25、 the working time required in order to obtain a satisfactory mix of the components 3.2 working time period of time, measured from the start of mixing, during which it is possible to manipulate a dental material without an adverse effect on its properties 3.3 net setting time period of time, measured
26、 from the end of mixing, until the material has set according to the criteria and conditions specified in Annex A NOTE For the purposes of this part of ISO 9917, in view of the wide variation in mixing times of cements, the net setting time is determined from the end of mixing. 4 EN ISO 9917-1:2007
27、(E) DIN EN ISO 9917-1:2008-01 4 Classification 4.1 Chemical type For the purposes of this part of ISO 9917, dental cements shall be classified on the basis of their chemical composition, as follows: a) zinc phosphate cement, see Clause B.1; b) zinc polycarboxylate cement, see Clause B.2; c) glass po
28、lyalkenoate cement, see Clause B.3. Acid-base setting, water-based cements other than those listed above may fall within the scope of this part of ISO 9917. If the manufacturer wishes to claim conformity for such a product, the type of material for which equivalence of properties is claimed shall be
29、 specified in accordance with 4.1 and 4.2 so that the correct performance limits are applied. 4.2 Application For the purposes of this part of ISO 9917, the application of water-based cements shall be classified as follows: a) luting; b) bases or lining; c) restoration. 5 Material 5.1 General The ce
30、ment shall consist of a powder and liquid which, when mixed in accordance with the manufacturers instructions, shall conform to requirements in this clause and Clause 8. 5.2 Components 5.2.1 Liquid For non-encapsulated cements, visually inspect the liquid. It shall be free from deposits or filaments
31、 on the inside of its container. There shall be no visible signs of gelation. 5.2.2 Powder For non-encapsulated cements, visually inspect the powder. It shall be free from extraneous material. If the powder is coloured, the pigment shall be uniformly dispersed throughout the powder. 5.3 Unset cement
32、 The cement shall be mixed in accordance with Clause 6, and then visually inspected. It shall be homogeneous and of a smooth consistency. 5 EN ISO 9917-1:2007 (E) DIN EN ISO 9917-1:2008-01 6 Preparation of test specimens 6.1 Ambient conditions Specimens shall be prepared at a temperature of (23 1) C
33、 and a relative humidity of (50 10) %. 6.2 Method of mixing The cement shall be prepared in accordance with the manufacturers instructions. Sufficient cement shall be mixed to ensure that the preparation of each specimen is completed from one mix. A fresh mix shall be prepared for each specimen. NOT
34、E For encapsulated materials, more than one capsule simultaneously mixed, may be required for certain specimens. 7 Sampling 7.1 Hand-mixed cements A sample drawn from one batch shall provide sufficient material to complete all the prescribed tests and any necessary repeats. NOTE Approximately 50 g o
35、f powder is necessary to complete the tests. 7.2 Encapsulated cements The test sample shall comprise a retail package of a sufficient number of capsules from one batch to complete all the tests and any necessary repeats. 8 Requirements 8.1 Net setting time When determined in accordance with Annex A,
36、 the net setting time of the cement shall conform to relevant requirements specified in Table 1. 8.2 Film thickness (luting cements only) When determined in accordance with Annex C, the film thickness shall conform to relevant requirements specified in Table 1. 8.3 Compressive strength When determin
37、ed in accordance with Annex D, the compressive strength of the cement shall conform to the relevant requirements specified in Table 1. 8.4 Acid erosion When determined in accordance with Annex E, the acid erosion of the cement shall conform to the relevant requirements specified in Table 1. 6 EN ISO
38、 9917-1:2007 (E) DIN EN ISO 9917-1:2008-01 8.5 Optical properties (polyalkenoate restorative cements only) When prepared, stored and tested in accordance with Annex F, cements shall meet the following requirements. a) The opacity of the set restorative cements shall be within the limits specified in
39、 Table 1, unless the restorative cement is designated as opaque by the manufacturer see 9.2 f). b) The colour of the set cement shall match the manufacturers shade guide. If a shade guide is not supplied by the manufacturer, then the manufacturer shall nominate a commercially available shade guide t
40、hat shall be used in assessing compliance with this requirement see 9.3.1 c). 8.6 Acid-soluble arsenic and lead contents 8.6.1 Acid-soluble arsenic content When determined in accordance with Annex G, the acid-soluble arsenic content shall not exceed the relevant limits specified in Table 1. 8.6.2 Ac
41、id-soluble lead content When determined in accordance with Annex G, the acid-soluble lead content shall not exceed the relevant limits specified in Table 1. 8.7 Radio-opacity (if claimed) When the manufacturer describes the material as being radio-opaque see 9.2 g), the radio-opacity shall be at lea
42、st equivalent to that for the same thickness of aluminium when determined in accordance with Annex H. When the manufacturer claims a greater radio-opacity, the measured value shall not be less than the value claimed when determined in accordance with Annex H. 9 Packaging, marking and information to
43、be supplied by manufacturer NOTE Additional information can be included at the discretion of the manufacturer or as required by other applicable rules or regulations. 9.1 Packaging The materials shall be supplied in containers or capsules (for the purposes of this part of ISO 9917, the container or
44、capsule shall be considered to be the immediate wrapping of the material) that afford adequate protection and have no adverse effect on the quality of the contents. An outer pack may also be used to present the containers or capsules as a single unit. 9.2 Marking Each outer container shall be clearl
45、y marked with the following details: a) the name and/or trademark of the manufacturer and the trade name, type and application of the cement; b) the shade of the powder according to the manufacturers nominated shade guide; c) the minimum net mass, in grams, of the powder or the minimum net volume, i
46、n millilitres of the liquid as appropriate; d) the manufacturers batch or lot number; 7 EN ISO 9917-1:2007 (E) DIN EN ISO 9917-1:2008-01 e) on the outermost packaging, the recommended conditions of storage, and the “expiry date” for the material under those conditions of storage; f) on the outer pac
47、kaging, whether the cement is designated opaque; g) on the outer packaging, whether the cement is designated as radio-opaque; h) on each outer container of encapsulated cements, the number of capsules in the container, and the net mass in each capsule. 9.3 Manufacturers instructions 9.3.1 General In
48、structions shall accompany each package of the material and shall include the following: a) the trade name of the product; b) the manufacturers name and contact details; c) a shade guide or, when no shade guide is provided, details of a commercially available shade guide for use with the material. I
49、n addition, at least the information in 9.3.2 or 9.3.3, as appropriate, shall be given. For those materials not mentioned specifically in 4.1, the manufacturer shall indicate the type of material (see 4.1 and 4.2) against whose performance requirements the material shall be tested. 9.3.2 Hand-mixed cements For hand-mixed cements, the following information shall be supplied: a) the temperature range for preparation; b) the recommended powder:liquid ratio, expressed as a mass:mass ratio for the recommended temperature range, and
