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1、BRITISH STANDARD BS EN ISO 9917-1:2003 Incorporating Corrigendum No. 1 Dentistry Water-based cements Part 1: Powder/liquid acid-base cements The European Standard EN ISO 9917-1:2003 has the status of a British Standard ICS 11.060.10 ? Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:02 G
2、MT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 9917-1:2003 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 10 December 2003 BSI 20 January 2004 ISBN 0 580 43054 5 National foreword This British Standard is the official English language v
3、ersion of EN ISO 9917-1:2003. It is identical with ISO 9917-1:2003. It supersedes BS EN 29917:1994 which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee CH/106, Dentistry, to Subcommittee CH/106/1, Dental restoative and orthodontic materials, which has the
4、responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section enti
5、tled “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 correct application. Complianc
6、e 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 the UK interests informed; monitor related int
7、ernational and European developments and promulgate them in the UK. Summary of pages This 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 iv, pages 1 to 22, the Annex ZA page and a back cover. The BSI copyright
8、 notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments 14973 Corrigendum No. 1 20 January 2004Incorporating corrected EN ISO foreword page and adding Annex ZA page Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 1
9、7 10:08:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9917-1 November 2003 ICS 11.060.10 English version Dentistry - Water-based cements - Part 1: Powder/liquid acid- base cements (ISO 9917-1:2003) Art dentaire - Ciments base deau - Partie 1:
10、Ciments acido-basiques liquides/en poudre (ISO 9917-1:2003) Zahnheilkunde - Wasserhrtende Zemente - Teil 1: Zemente, die beim Vermischen von Pulver und Flssigkeit ber eine Sure-Base-Reaktion abbinden (ISO 9917- 1:2003) This European Standard was approved by CEN on 3 October 2003. CEN members are bou
11、nd to comply with the CEN/CENELEC Internal Regulations which 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 M
12、anagement Centre or to any CEN member. This European Standard 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 Management Centre has the same status as t
13、he official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN CO
14、MMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2003 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 9917-1:2003 E Licensed Copy: s
15、heffieldun sheffieldun, na, Fri Nov 17 10:08:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI I NESO 99-71:12( 300E) 2 CORRECTED 2003-12-17 Foreword This document (EN ISO 9917-1:2003) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration with Technical Committee CEN/TC 55 “De
16、ntistry“, the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by May 2004, and conflicting national standards shall be withdrawn at the latest by May 2004. Accord
17、ing to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, N
18、orway, Portugal, Slovakia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 9917-1:2003 has been approved by CEN as EN ISO 9917-1:2003 without any modifications. NOTE Normative references to International Standards are listed in Annex ZA (normative). EN ISO 99171
19、:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 9917-1:2003(E) INTERNATIONAL STANDARD ISO 9917-1 First edition 2003-11-01 Dentistry Water-based cements Part 1: Powder/liquid acid-base cements Art dentaire Ciments b
20、ase deau Partie 1: Ciments acido-basiques liquides/en poudre EN ISO 99171:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI caceptl on siibality in this .aera Ai ebods a tedarmfo kra Aebod SystemI snctaropro.de teDials fo teh sfotwcudorp
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22、 plsaee ifnrom ttneC ehlar Secterirata ta teh serddaig sleb nevwo. ii EN ISO 99171:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii Contents Page Forewordiv 1 Scope1 2 Normative references .1 3 Terms and definitions.1 4 Classificatio
23、n.2 5 Material.2 6 Preparation of test specimens.3 7 Sampling3 8 Net setting time .3 9 Film thickness (luting cements only)3 10 Compressive strength3 11 Acid erosion 4 12 Optical properties (polyalkenoate restorative cements only)4 13 Acid-soluble arsenic and lead contents.4 14 Radiopacity4 15 Packa
24、ging, marking and information to be supplied by manufacturer.4 Annex A (normative) Determination of net setting time.7 Annex B (informative) Chemical compositions and applications of dental cements9 Annex C (normative) Determination of film thickness (luting cements only)10 Annex D (normative) Deter
25、mination of compressive strength12 Annex E (normative) Determination of acid erosion 14 Annex F (normative) Determination of optical properties (polyalkenoate restorative cements only) 17 Annex G (normative) Determination of acid-soluble arsenic and lead contents.20 Annex H (normative) Determination
26、 of radiopacity 21 EN ISO 99171:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of
27、 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 committee. International organizations, governmental and non-governmental
28、, 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 accordance with the rules given in the ISO/IEC Directives, Part 2. The main
29、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 requires approval by at least 75 % of the member bodies casting a vote. Atten
30、tion 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 9917-1 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and resto
31、rative materials. This part of ISO 9917 cancels and replaces ISO 9917:1991, which has been technically revised. ISO 9917 consists of the following parts, under the general title Dental materials Water-based cements: Part 1: Powder/liquid acid-base cements Part 2: Light-activated cements EN ISO 99171
32、:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 1 Dentistry Water-based cements Part 1: Powder/liquid acid-base cements 1 Scope This part of ISO 9917 specifies requirements and test methods for powder/liquid acid-base dental cements in
33、tended for permanent cementation, lining and restoration. It is applicable to both hand-mixed cements and encapsulated cements for mechanical mixing. It specifies limits for each of the properties according to whether the cement is intended for use as a luting agent, a base or liner, or a restorativ
34、e material. Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this part of ISO 9917, but it is recommended that, in assessing possible biological or toxicological hazards, reference should be made to ISO 7405, Dentistry Preclinical evaluation o
35、f biocompatibility of medical deviced used in dentistry Test methods for dental materials, and ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing. 2 Normative references The following referenced documents are indispensable for the application of this document. For d
36、ated references, 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, Photography Intra-oral denta
37、l radiographic film Specification ISO 3696, 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
38、of 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 EN ISO 99171:2003 Licensed Copy: sheffieldu
39、n sheffieldun, na, Fri Nov 17 10:08:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 2 3.3 net setting time period of time, measured 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 o
40、f the wide variation in mixing times of cements, the net setting time is determined from the end of mixing. 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 cemen
41、t, see Clause B.1; b) zinc polycarboxylate cement, see Clause B.2; c) glass polyalkenoate 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 a particular p
42、roduct, the manufacturer shall specify the type of material 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, materials shall be classified on the basis of their usage as follows: a) luting cements; b) bases
43、or liners; c) restorative cements. 5 Material 5.1 General The cement shall consist of a powder and liquid which, when mixed in accordance with the manufacturers instructions, shall conform with the requirements in this clause and in Clauses 8 to 15. 5.2 Components 5.2.1 Liquid For non-encapsulated c
44、ements, visually inspect the liquid. It shall be free from deposits or filaments 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,
45、the pigment shall be uniformly dispersed throughout the powder. Encapsulated cements shall not be examined in this way. EN ISO 99171:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 3 5.3 Unset cement The cement shall be mixed in accorda
46、nce with Clause 6, and then visually inspected. It shall be homogeneous and of a smooth consistency. 6 Preparation of test specimens 6.1 Ambient conditions All specimens shall be prepared at a temperature of (23 1) C and a relative humidity of (50 10) %. 6.2 Method of mixing The cement shall be prep
47、ared 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. NOTE For encapsulated materials, more than one capsule simultaneously mixed may be requ
48、ired for certain specimens. 7 Sampling 7.1 Hand-mixed cements The sample, drawn from one batch, shall provide sufficient material to complete all the prescribed tests and any necessary repeats. NOTE Approximately 50 g of powder is necessary to complete the tests. 7.2 Encapsulated cements The sample
49、shall comprise a retail package of a sufficient number of capsules from one batch to complete all the tests. 8 Net setting time When determined in accordance with Annex A, the net setting time of the cement shall conform to relevant requirements specified in Table 1. 9 Film thickness (luting cements only) When determined in accordance with Annex C, the film thickness shall conform to relevant requirements specified in Table 1. 10 Compressive strength