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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN ISO 9917-2:2000 The
2、 European Standard EN ISO 9917-2:1999 has the status of a British Standard ICS 11.060.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Dental water-based cements Part 2: Light-activated cements Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:09:14 GMT+00:00 2006, U
3、ncontrolled Copy, (c) BSI This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 February 2000 BSI 02-2000 ISBN 0 580 35872 0 BS EN ISO 9917-2:2000 Amendm
4、ents issued since publication Amd. No.DateComments National foreword This British Standard is the official English language version of EN ISO 9917-2:1999. It is identical with ISO 9917-2:1998. The UK participation in its preparation was entrusted to Technical Committee CH/53, Dental restorative and
5、orthodontic materials, which has the responsibility to: 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 international and European devel
6、opments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references Attention is drawn to the fact that CEN and CENELEC Standards normally include an annex which lists normative references to international publica
7、tions with their corresponding European publications. The British Standards which implement these international or European publications may be found in the BSI Standards Catalogue under the section entitled International Standards Correspondence Index, or by using the Find facility of the BSI Stand
8、ards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pag
9、es 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 14, the annex ZA page and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Li
10、censed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:09:14 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:09:14 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 9917-2:1999 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:09:14 GMT+0
11、0:00 2006, Uncontrolled Copy, (c) BSI AReference number ISO 9917-2:1998(E) INTERNATIONAL STANDARD ISO 9917-2 First edition 1998-07-01 Dental water-based cements Part 2: Light-activated cements Ciments dentaires hydrauliques Partie 2: Ciments photo-activs EN ISO 9917-2:1999 Licensed Copy: sheffieldun
12、 sheffieldun, na, Wed Nov 15 13:09:14 GMT+00:00 2006, Uncontrolled Copy, (c) BSI )E(8991:2-7199 OSI Descriptors: dentistry, dental materials, dental cements, classification, specifications, materials specifications, tests, performance tests, marking, packaging, instructions. ii Contents 1 Scope 1 2
13、Normative references 1 3 Definitions 1 4 Classification 2 5 Requirements. 2 6 Sampling. 3 7 Test methods 3 7.1 Preparation of test specimens and test conditions 3 7.2 Sensitivity to ambient light . 4 7.3 Setting time and initial hardening time 5 7.4 Depth of cure 6 7.5 Flexural Strength 7 7.6 Radiop
14、acity. 9 7.7 Opacity (restorative cements only) . 10 7.8 Shade and colour stability (restorative cements only) 11 8 Packaging, marking and information to be supplied by manufacturer 12 Annex A Bibliography 14 EN ISO 9917-2:1999 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:09:14 GMT+00:0
15、0 2006, Uncontrolled Copy, (c) BSI OSI)E(8991:2-7199 OSI iii 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 commi
16、ttees. 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, in liaison with ISO, also take part in the work. ISO collaborates closely with the I
17、nternational Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. 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 memb
18、er bodies casting a vote. International Standard ISO 9917-2 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and restorative materials. ISO 9917 consists of the following parts, under the general title Dental water-based cements: Part 1: (at present ISO 9917:1991
19、) Part 2: Light-activated cements. Annex A of this part of ISO 9917 is for information only. EN ISO 9917-2:1999 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:09:14 GMT+00:00 2006, Uncontrolled Copy, (c) BSI )E(8991:2-7199 OSI OSI iv Introduction This part of ISO 9917 has been prepared in
20、 order to present the requirements and test methods for water-based cements in which setting is activated by an external radiation source. Some products which fall within the scope of this part of ISO 9917 may also have a second mode of activation. As far as possible, test methods employed within th
21、is part of ISO 9917 have been harmonized with those used in ISO 4049 and ISO 9917:1991. NOTE Existing standard ISO 9917:1991 will become ISO 9917-1 on revision. Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this part of ISO 9917, but it is
22、recommended that when assessing possible biological or toxicological hazards reference be made to ISO 10993-1 and ISO 7405. EN ISO 9917-2:1999 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:09:14 GMT+00:00 2006, Uncontrolled Copy, (c) BSI INTERNATIONAL STANDARD ISOISO 9917-2:1998(E) 1 Den
23、tal water-based cements Part 2: Light-activated cements 1 Scope This part of ISO 9917 specifies requirements for dental cements, including hand-mixed, encapsulated cements used for mechanical mixing and one-component materials, which are intended for base, lining and restoration purposes and for whi
24、ch the materials are water-based and set by multiple reactions which include an acid-base reaction and polymerization. EXAMPLE Conventional glass polyalkenoate cements are normally formed by reacting an ion-leachable aluminosilicate glass with a polyalkenoic acid in an aqueous environment. Materials
25、 which fall within the scope of this part of ISO 9917 will normally be able to effect setting by such an aqueous acid-base type reaction, but in addition will be able to effect rapid setting through exposure to a suitable source of radiation. NOTE Attention of manufacturers and test houses is drawn
26、to the closely related International Standards ISO 4049 and ISO 9917:1991. Consideration should be given as to the most appropriate International Standard by which to evaluate any individual product. 2 Normative references The following standards contain provisions which, through reference in this t
27、ext, constitute provisions of this part of ISO 9917. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this part of ISO 9917 are encouraged to investigate the possibility of applying the most recent editions of th
28、e standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 3665:1996, Photography Intra-oral dental radiographic film Specification. ISO 3696:1987, Water for analytical use Specification and test methods. ISO 7491:1985, Dental materials Det
29、ermination of colour stability of dental polymeric materials. ISO 9917:1991, Dental water-based cements. 3 Definitions For the purposes of this part of ISO 9917, the definitions given in ISO 9917:1991 and the following definitions apply. 3.1 setting time in the absence of activating radiation period
30、 of time, measured from start of mixing, until the completion of set as defined in 7.3.1. EN ISO 9917-2:1999 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:09:14 GMT+00:00 2006, Uncontrolled Copy, (c) BSI )E(8991:2-7199 OSI OSI 2 NOTE In this part of ISO 9917, setting time is determined i
31、n the absence of activating radiation and is used to classify products as type I or type II. 3.2 initial hardening time in the absence of activating radiation period of time, measured from start of mixing, until a penetrator of given load and dimensions is unable to penetrate to within 0,1 mm of the
32、 bottom of a sample of cement 5 mm thick, as described in 7.3.2. NOTE In this part of ISO 9917 an estimate of working time is given by initial hardening time. 4 Classification 4.1 Clinical application For the purposes of this part of ISO 9917, clinical application of these dental cements is classifi
33、ed as follows: a) Bases and liners b) Restorative cements 4.2 Setting reaction For the purposes of this part of ISO 9917, these dental cements are classified on the basis of their setting characteristics as follows: a) Type I: Products that undergo setting by light activation but also set in the abs
34、ence of activating light (see 5.4 and 7.3.1). b) Type II: Products that set only after application of activating light (see 7.3.1). 5 Requirements 5.1 Material The cement may consist of a number of components that, when treated in accordance with the manufacturers instructions, produces a material w
35、hich will comply with the requirements of this part of ISO 9917. When supplied as separate components for hand or mechanical mixing, the individual powder(s) and/or liquid(s) shall be free from extraneous matter (see 7.1.2). There shall be no visible signs of gelation in liquid components (see 7.1.2
36、). 5.2 Sensitivity to ambient light When tested in accordance with 7.2, there shall be no detectable change in the homogeneity of any of the three samples after being exposed to the test light for 30 s. 5.3 Setting time (in the absence of activating radiation) When tested in accordance with 7.3, the
37、 setting time of type I materials in the absence of activating light shall be less than 60 min. 5.4 Initial hardening time in the absence of activating radiation (Type I materials only) When tested in accordance with 7.3, the initial hardening time (measured in the absence of activating light) shall
38、 not be less than the value of the working time given by the manufacturer see 8.3 f). EN ISO 9917-2:1999 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:09:14 GMT+00:00 2006, Uncontrolled Copy, (c) BSI OSI)E(8991:2-7199 OSI 3 5.5 Depth of cure When tested in accordance with 7.4, the depth
39、of cure shall not be less than 1 mm. If the manufacturer claims a greater depth of cure, the measured value shall not be more than 0,5 mm below the value stated by the manufacturer. 5.6 Flexural strength When tested in accordance with 7.5, the flexural strength shall not be less than 20 MPa for rest
40、orative cements or 10 MPa for bases and liners. 5.7 Radiopacity (if claimed) If the manufacturer claims that the material is radiopaque see 8.2 d), the radiopacity, determined in accordance with 7.6, shall be at least the same as the equivalent thickness of aluminium and not more than 0,5 mm below t
41、he value claimed by the manufacturer. 5.8 Opacity (restorative cements only) When tested in accordance with 7.7, the cement shall have an opacity within the limits defined by the optical standards (i.e. between 0,35 and 0,90). This requirement does not apply to cements designated as opaque by the ma
42、nufacturer see 8.2 c). 5.9 Shade and colour stability (restorative cements only) When tested in accordance with 7.8, the shade of the material shall match closely that of the shade guide specified by the manufacturer. When tested in accordance with 7.8 and ISO 7491, there shall be no more than a sli
43、ght change in colour after 7 days. 6 Sampling A sample drawn from one batch shall provide sufficient material to complete all the prescribed tests and any necessary repeats. The test sample shall consist of packages prepared for retail sale. 7 Test methods 7.1 Preparation of test specimens and test
44、conditions 7.1.1 Test conditions Unless specified otherwise by the manufacturer, prepare and test all specimens at a temperature of (23 1) oC. Control the relative humidity to ensure that it remains greater than 30 % at all times. If the material was refrigerated for storage, allow it to attain (23
45、1) oC. Adequate provision shall be made for the exclusion of activating radiation when such conditions are required. Ambient light, both natural and artificial, is capable of activating these materials. For good control, the test should be performed in a dark room with any artificial light filtered
46、by a yellow filter. Water used in all tests specified in this part of ISO 9917 shall be prepared in accordance with ISO 3696 Grade 2. 7.1.2 Inspection requirements Visual inspection shall be used in determining compliance with 5.1, 5.2, 5.8, 5.9 and clause 8. EN ISO 9917-2:1999 Licensed Copy: sheffi
47、eldun sheffieldun, na, Wed Nov 15 13:09:14 GMT+00:00 2006, Uncontrolled Copy, (c) BSI )E(8991:2-7199 OSI OSI 4 7.1.3 Method of mixing The cement shall be prepared according to the manufacturers instructions. Sufficient cement shall be mixed to ensure that the preparation of each specimen is complete
48、d 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. Likewise, for materials supplied in single-dose containers, several containers may be required for each test specimen.
49、 7.2 Sensitivity to ambient light 7.2.1 Apparatus 7.2.1.1 Xenon lamp or radiation source of equivalent performance (a suitable apparatus is described in ISO 7491) with colour-conversion and ultraviolet filters inserted. The colour-conversion filter1) shall be hardened glass 3 mm thick and shall have an internal transmittance which matches within 10% that shown in figure 1. The ultraviolet filter shall be made of borosilicate glass with a transmittance of less than 1 % below 300 nm and greater than 90 % above 37
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