ISO 13017 AMD 1-2015 Dentistry - Magnetic attachments Amendment 1《牙科 磁性附着体 修改件1》.pdf

1、 ISO 2015 Dentistry Magnetic attachments AMENDMENT 1 Mdecine bucco-dentaire Attaches magntiques AMENDEMENT 1 INTERNATIONAL STANDARD ISO 13017 First edition 2012-07-15 Reference number ISO 13017:2012/Amd.1:2015(E) AMENDMENT 1 2015-11-15 ISO 13017:2012/Amd.1:2015(E)ii ISO 2015 All rights reserved COPY

2、RIGHT PROTECTED DOCUMENT ISO 2015, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, w

3、ithout prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyrightiso.org www.

4、iso.org ISO 13017:2012/Amd.1:2015(E) 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. Each member body

5、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 International Electrotech

6、nical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO

7、documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives 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 responsibl

8、e for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received. www.iso.org/patents Any trade name used in this document is information given for the co

9、nvenience of users and does not constitute an endorsement. For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT), see the following URL: Fore

10、word - Supplementary information The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials. ISO 2015 All rights reserved iii Dentistry Magnetic attachments AMENDMENT 1 Page 1, Clause 2 Add the following reference: “ISO 14233, Dentistry Polymer-b

11、ased die materials”Page 1, Clause 3 Replace the definition of 3.1 with the following: “device to provide retention of a prosthesis utilizing magnetic attraction” Replace the definition of 3.1.1 with the following: “magnetic attachment which utilizes an open magnetic circuit between the coupled devic

12、e components” Replace the NOTE of 3.1.1 with the following: “The magnet is encased within a corrosion-resistant metal or alloy cover of titanium, titanium alloy or stainless steel to prevent corrosion of the magnet. The attachment uses either a magnet and a ferromagnetic alloy keeper or two magnets

13、as retentive coupling components.”Page 2, Clause 3 Replace the definition of 3.2 with the following: “assembly composed of a small magnet which is sealed within ferromagnetic yokes and a non- magnetic spacer, completing a closed magnetic circuit with a keeper”Page 3, Clause 3 Replace the definition

14、of 3.3 with the following: “ferromagnetic alloy component fixed to an abutment to retain a prosthesis” Replace the NOTE of 3.3 with the following: “The keeper is placed across the poles of a magnet or a magnetic assembly to complete the magnetic circuit.” Replace the definition of 3.4 with the follo

15、wing: “ferromagnetic alloy component connected to a permanent magnet and used for concentrating magnetic flux” ISO 13017:2012/Amd.1:2015(E) ISO 2015 All rights reserved 1 ISO 13017:2012/Amd.1:2015(E) Page 4, Subclause 4.4 Replace the superscript number “ 3 ” with the superscript number “ 5 ”.Page 4,

16、 Subclause 4.6.1 Replace the cross-reference “(see 6.4.1.4)” with “(see 6.4.1.3)”.Page 4, Subclause 4.6.2 Replace the existing subclause with the following: “Breakdown potentials of the magnet or the magnetic assembly and the keeper shall be equal to, or higher than, that of wrought stainless steel

17、in accordance with ISO 5832-1 when tested in accordance with 6.4.2.”Page 4, Subclause 5.1 Replace the cross-reference “(see 6.3.2)” with “(see 6.3.4)”.Page 5, Subclause 6.2.1.1 Replace the existing text with the following: “Gauss meter, using a Hall element and in accordance with ISO/IEC 17025.”Page

18、 5, Subclause 6.2.2 Replace the cross-reference to “(6.2.1)” with “(6.2.1.1)”.Page 5, Subclause 6.3.1.2 Replace the existing text with the following: “Device, containing a low friction ball bearing slider, for fixing and pulling the specimens vertically, installed in the mechanical testing machine.

19、NOTE The force required to move the shaft of the device when pulling a specimen should be 0,02 N or less. The lower or upper table can be modified to facilitate fixation of the specimen (magnet, magnetic assembly, or keeper) in a stable manner. See Figure 3.”Page 5, Subclause 6.3.1.2 Add the followi

20、ng subclauses to the end of 6.3.1.2.2 ISO 2015 All rights reserved ISO 13017:2012/Amd.1:2015(E) 6.3.2 Materials 6.3 .2. 1 A dh e s i v e d o u b l e s i d e d ta p e , without any residual adhesive on the adhered face after the removal of the tape, for the temporary joining of the specimens and the

21、tables of the device during the alignment procedure. 6.3.2.2 Cyanoacrylate adhesive, for fixing specimens on the lower- and upper-tables. 6.3.2.3 Self-curing acrylic resin, for embedding a non disk-shaped specimen in the embedding ring with properties in accordance with ISO 14233:2003. 6.3.3 Fixing

22、procedure 6.3.3.1 Fixation of specimens Adjust the position of the lower-table equipped with the device (6.3.1.2) using the X-Y stage so that both centers of the lower- and upper-table are aligned. Attach the mating face of the magnet (or magnetic assembly) to the centre of the lower-table using an

23、adhesive double sided tape (6.3.2.1). Note that the side attached to the double sided tape will be the side that mates with the other magnet (or keeper) once the alignment procedure is completed. Place a drop of the cyanoacrylate adhesive (6.3.2.2) on the top of the magnet (or magnetic assembly) att

24、ached on the lower-table with the double sided tape, being careful not to let the glue flow down the sides of the magnet (or magnetic assembly). Move the upper-table down slowly until it makes contact with the magnet (or magnetic assembly) containing the drop of glue. If necessary, reinforce the bon

25、ding area between the magnetic (or magnetic assembly) and the upper-table with the self-curing acrylic resin (6.3.2.3). After the adhesive joining the magnet (or magnetic assembly) with the upper-table is set, move the table upward and remove the adhesive double sided tape (6.3.2.1), which was used

26、for alignment, from the mating face of the magnet (or magnetic assembly). Put the magnet (or keeper) on the mating face of the magnet (or magnetic assembly) that is now bonded to the upper-table. Make sure that the magnet (or keeper) is properly aligned with the magnet (or magnetic assembly). Place

27、a drop of the cyanoacrylate adhesive (6.3.2.2) at the centre of the lower-table. Move the upper-table down slowly until the bottom of the magnet (or keeper) makes contact with the lower-table containing the drop of glue. If necessary, reinforce the bonding area between the magnet (or keeper) and the

28、 lower-table with the self-curing acrylic resin (6.3.2.3). Dont move the lower- or upper-table until the adhesive joining the magnet (or keeper) with the lower-table is set. Also, to keep the proper alignment of the magnet (or magnetic assembly) on the upper-table with the magnet (or keeper) on the

29、lower-table, do not uninstall the lower- and upper-tables from the device (6.3.1.2) even after the adhesive is set.Page 5, Subclause 6.3.2 Replace the subclause number 6.3.2 Test procedure with 6.3.4 Test procedure. Replace the second sentence of first paragraph with the following: “Install the devi

30、ce for fixing and pulling the specimens vertically (6.3.1.2) in the mechanical testing machine.” Replace the second paragraph with the following: “For each specimen, obtain retention measurement values both at point of separation (A, Figure 4) and then following mating face separation (B, Figure 4).

31、 To obtain the mating face separation force, which demonstrates loss of magnetic effect, calculate and record a median value for region B of the retentive force curve in Figure 4. Subtract this obtained median value from the initial separation ISO 2015 All rights reserved 3 ISO 13017:2012/Amd.1:2015

32、E) point value (A). The calculated difference is the retentive force. Repeat this procedure a minimum of five times for each specimen. Record the median retentive force.”4 ISO 2015 All rights reserved ISO 13017:2012/Amd.1:2015(E) Page 6, Figure 3 Replace the Figure 3 including the figure title and

33、key with the following: a) Front view b) Side view Key 1 rail for a ball bearing slider 2 shaft 3 low friction ball bearing slider 4 upper non-magnetic table 5 specimen (magnet or magnetic assembly) 6 specimen (magnet or keeper) 7 lower non-magnetic table 8 x-y stage a Connected to the mechanical te

34、sting machine. Figure 3 Device using a low friction ball bearing slider for fixing and pulling the specimens vertically ISO 2015 All rights reserved 5 ISO 13017:2012/Amd.1:2015(E) Page 6, new Figure 4 Add the following new Figure 4 after Figure 3 including the figure title and key: Key X distance Y

35、tensile force A initial separation point value (A) B mating face separation force (B) C retentive force (A B) a Point of separation. b Region B. Figure 4 Retentive Force Curve Page 7, subclause 6.4.1.5 Replace the words “(e.g. AAS and ICP)” in the second sentence with “(e.g. AAS and ICP-OES)” Replac

36、e the fourth sentence with the following: “Emphasis shall be on those elements listed in 7 a), but if ions other than the elements listed in 7 a) are found in a concentration greater than that of their minimum limit of determination in the test solution, each ions name and each amount of released io

37、ns in the units “g/cm 2 /7d.” shall also be reported.” Delete the sixth sentence. Add the following sentence to the end of the last sentence of the subclause: “The minimum limit of determination is defined as a tenfold concentration of standard deviation in analysis of a reference solution.”6 ISO 20

38、15 All rights reserved ISO 13017:2012/Amd.1:2015(E) Page 8, subclause 6.4.2.4 Replace the entire paragraph with the following: “Obtain anodic polarization curves of the magnet or the magnetic assembly and the keeper in accordance with ISO 10271.”Page 8, subclause 6.4.2.5 Replace the entire paragraph

39、 with the following: “Obtain each breakdown potential from the anodic polarization curves of the magnet or the magnetic assembly and the keeper, and compare the potential with that of wrought stainless steel in accordance with ISO 5832-1.”Page 8, Clause 7 Replace the bullet b) with the following: “the maximum magnetic leakage 5 mm from the surface of the dental magnetic attachment under the conditions of use when the average of five measurements is over 40 mT”; ISO 2015 All rights reserved 7 ISO 13017:2012/Amd.1:2015(E) ISO 2015 All rights reserved ICS 11.060.10 Price based on 7 pages