BS EN ISO 9917-1-2007 Dentistry - Water-based cements - Powder liquid acid-base cements《牙科学 水基粘结剂 粉末 液体酸基粘结剂》.pdf

1、BRITISH STANDARDBS EN ISO 9917-1:2007Dentistry Water-based cements Part 1: Powder/liquid acid-base cementsThe European Standard EN ISO 9917-1:2007 has the status of a British StandardICS 11.060.10g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g

2、38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 9917-1:2007This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2007 BSI 2007ISBN 978 0 580 59694 0National forewordThis British

3、Standard is the UK implementation of EN ISO 9917-1:2007. It supersedes BS EN ISO 9917-1:2003 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/106, Dentistry, to Subcommittee CH/106/1, Dental restorative and orthodontic materials.A list of organizatio

4、ns represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.Ame

5、ndments issued since publicationAmd. No. Date CommentsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 9917-1October 2007ICS 11.060.10 Supersedes EN ISO 9917-1:2003 English VersionDentistry - Water-based cements - Part 1: Powder/liquid acid-base cements (ISO 9917-1:2007)Art dentaire - Ciments b

6、ase deau - Partie 1: Cimentsacido-basiques liquides/en poudre (ISO 9917-1:2007)Zahnheilkunde - Wasserhrtende Zemente - Teil 1:Zemente, die beim Vermischen von Pulver und Flssigkeitber eine Sure-Base-Reaktion abbinden (ISO 9917-1:2007)This European Standard was approved by CEN on 8 October 2007.CEN m

7、embers are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on applicat

8、ion to the CEN Management 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has th

9、e same status as theofficial versions.CEN members are the national standards 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,

10、Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2007 CEN All rights of exploitation in any form and by any means reserve

11、dworldwide for CEN national Members.Ref. No. EN ISO 9917-1:2007: EForeword 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 Standar

12、d shall be given the status of a national standard, either by publication 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

13、Internal Regulations, the national standards organizations of the following 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

14、, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, 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 9917-1:2007Reference numberISO 9917-1:2007(

15、E)INTERNATIONAL STANDARD ISO9917-1Second edition2007-10-01Dentistry Water-based cements Part 1: Powder/liquid acid-base cements Art dentaire Ciments base deau Partie 1: Ciments acido-basiques liquides/en poudre EN ISO 9917-1:2007ii iiiContents Page Foreword iv 1 Scope . 1 2 Normative references . 1

16、3 Terms and definitions. 1 4 Classification. 2 5 Material 2 6 Preparation of test specimens 3 7 Sampling 3 8 Requirements 3 9 Packaging, marking and information to be supplied by manufacturer. 4 Annex A (normative) Determination of net setting time. 7 Annex B (informative) Chemical composition and a

17、pplications of dental cements . 9 Annex C (normative) Determination of film thickness (luting cements only) 10 Annex D (normative) Determination of compressive strength 12 Annex E (normative) Determination of acid erosion 14 Annex F (normative) Determination of optical properties (polyalkenoate rest

18、orative cements only) 17 Annex G (normative) Determination of acid-soluble arsenic and lead contents. 20 Annex H (normative) Determination of radio-opacity. 21 Bibliography . 23 EN ISO 9917-1:2007iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of nation

19、al 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 committee. Internatio

20、nal 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 accordance with the rule

21、s 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 requires approval by at l

22、east 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 9917-1 was prepared by Technical Committee ISO/TC

23、106, Dentistry, Subcommittee SC 1, Filling and restorative materials. This second edition cancels and replaces the first edition (ISO 9917-1:2003), of which it constitutes a minor revision. The main purpose for modification of this part of ISO 9917 was to include a new test method for acid erosion,

24、a new test and requirement for radio-opacity and to distinguish between the requirements for manufacturers instructions for hand-mixed cements and those for capsulated cements. Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this part of ISO

25、9917, but it is recommended that, in assessing possible biological or toxicological hazards, reference should be made to ISO 7405 and ISO 10993-1. A bibliography has been added to this document. ISO 9917 consists of the following parts, under the general title Dentistry Water-based cements: Part 1:

26、Powder/liquid acid-base cements Part 2: Light-activated cements EN ISO 9917-1:20071Dentistry 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 intended for permanent cementation

27、, 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 is intended for use as a luting agent, a base or liner or as a restorative

28、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 references, only the edition cited applies. For undated references, the latest ed

29、ition 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 radiographic film Specification ISO 3696:1987, Water for analytical laboratory

30、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 the working time required in order to obtain a satisfactory mix of the co

31、mponents 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 from the end of mixing, until the material has set according to the crite

32、ria 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. EN ISO 9917-1:20072 4 Classification 4.1 Chemical type For the purposes of this part of ISO 991

33、7, 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 polyalkenoate cement, see Clause B.3. Acid-base setting, water-based cements other than those listed above

34、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 specified in accordance with 4.1 and 4.2 so that the correct performance limits are applied. 4.2 Applica

35、tion 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 cement shall consist of a powder and liquid which, when mixed in accordance with the manufacturers instruct

36、ions, 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 on the inside of its container. There shall be no visible signs of gelation. 5.2.2 Powder For non-encaps

37、ulated 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 The cement shall be mixed in accordance with Clause 6, and then visually inspected. It shall be homogene

38、ous and of a smooth consistency. EN ISO 9917-1:200736 Preparation of test specimens 6.1 Ambient conditions 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 prepared in accordance with the manufacturers instruction

39、s. 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 required for certain specimens. 7 Sampling 7.1 Hand-mixe

40、d 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 of powder is necessary to complete the tests. 7.2 Encapsulated cements The test sample shall comprise a retail package of a sufficient num

41、ber 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, the net setting time of the cement shall conform to relevant requirements specified in Table 1. 8.2 Film thickness (luting cements only)

42、 When determined in accordance with Annex C, the film thickness shall conform to relevant requirements specified in Table 1. 8.3 Compressive strength When determined in accordance with Annex D, the compressive strength of the cement shall conform to the relevant requirements specified in Table 1. 8.

43、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. EN ISO 9917-1:20074 8.5 Optical properties (polyalkenoate restorative cements only) When prepared, stored and tested in accordance with Annex F,

44、cements shall meet the following requirements. a) The opacity of the set restorative cements shall be within the limits specified in 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 guid

45、e. If a shade guide is not supplied by the manufacturer, then the manufacturer shall nominate a commercially available shade guide that 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 determi

46、ned in accordance with Annex G, the acid-soluble arsenic content shall not exceed the relevant limits specified in Table 1. 8.6.2 Acid-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-o

47、pacity (if claimed) When the manufacturer describes the material as being radio-opaque see 9.2 g), the radio-opacity shall be at least 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

48、 value shall not be less than the value claimed when determined in accordance with Annex H. 9 Packaging, marking and information to 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

49、.1 Packaging The materials shall be supplied in containers or capsules (for the purposes of this part of ISO 9917, the container or 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 clearly marked with the following details: a) the name and/or trademark of the manufacturer and the trade