ISO-3630-1-2008.pdf
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1、 Reference number ISO 3630-1:2008(E) ISO 2008 INTERNATIONAL STANDARD ISO 3630-1 Second edition 2008-02-01 Dentistry Root-canal instruments Part 1: General requirements and test methods Art dentaire Instruments pour canaux radiculaires Partie 1: Exigences gnrales et mthodes dessai Copyright Internati
2、onal Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 02/16/2008 04:01:35 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 3630-1:2008(E) PDF disclaimer This PDF file may contain em
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4、f not infringing Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameter
5、s were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2008 All rights
6、reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the re
7、quester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2008 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with IS
8、O Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 02/16/2008 04:01:35 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 3630-1:2008(E) ISO 2008 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references. 1 3 Term
9、s, definitions and symbols 1 3.1 Terms and definitions. 1 3.2 Symbols. 3 4 Classification. 3 5 Requirements 3 5.1 General. 3 5.2 Type 1: standard-sized instruments. 3 5.3 Type 2: taper-sized instruments 5 5.4 Type 3: shape-sized instruments 6 5.5 Type 4: non-taper-sized instruments 7 5.6 Type 5: non
10、-uniform taper-sized instruments . 8 5.7 Material 9 5.8 Dimensions 9 5.9 Mechanical requirements. 9 5.10 Chemical requirements 10 6 Sampling 10 7 Testing . 10 7.1 Visual inspection 10 7.2 Test conditions . 10 7.3 Measurement of dimensions . 11 7.4 Resistance to fracture by twisting and angular defle
11、ction. 11 7.5 Stiffness. 13 7.6 Handle and shank security 14 7.7 Corrosion test . 14 7.8 Heat effects of sterilization 15 8 Designation, marking and identification 16 8.1 General. 16 8.2 Identification symbols 16 9 Packaging 16 10 Manufacturers instructions for use 16 11 Labelling 17 Bibliography. 1
12、8 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 02/16/2008 04:01:35 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 3630-1:2008(E) iv ISO 2008 All rights
13、 reserved 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 interested in a subject for
14、 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 Electrotechnical Commission (IEC) on a
15、ll matters of electrotechnical standardization. International Standards are drafted in accordance with the rules 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
16、 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. 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 re
17、sponsible for identifying any or all such patent rights. ISO 3630-1 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments. This second edition cancels and replaces the first edition (ISO 3630-1:1992), which has been technically revised. ISO 3630 consists of
18、 the following parts, under the general title Dentistry Root-canal instruments: Part 1: General requirements and test methods Part 2: Enlargers Part 3: Condensers, pluggers and spreaders Part 4: Auxiliary instruments Copyright International Organization for Standardization Provided by IHS under lice
19、nse with ISO Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 02/16/2008 04:01:35 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 3630-1:2008(E) ISO 2008 All rights reserved v Introduction The reorganization of ISO 3630 is intended to present the requi
20、rements and test methods for root-canal instruments in an orderly manner. This part of ISO 3630 defines general requirements and test methods. Subsequent parts provide the specific requirements and test methods, if applicable, for two areas of endodontic procedures. These parts are enlargers, conden
21、sers and auxiliary instruments. With current use of nickel-titanium (Ni-Ti) alloys for manufacture of root canal instruments a need for adequate expertise in their safe use is recommended. Instruments made of Ni-Ti can be easily broken near the tip if manufacturers cautions are not understood and pr
22、acticed. This part of ISO 3630 does not attempt to provide information for proper use of any instruments. The sizes of the root-canal obturating points (cones) specified in ISO 68774 have to be aligned with the corresponding sizes for root-canal instruments specified in ISO 3630. Copyright Internati
23、onal Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 02/16/2008 04:01:35 MSTNo reproduction or networking permitted without license from IHS -,-,- Copyright International Organization for Standardization Provi
24、ded by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 02/16/2008 04:01:35 MSTNo reproduction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARD ISO 3630-1:2008(E) ISO 2008 All rights reserved 1 Dentistry Root-canal instruments
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