ISO-20795-1-2008.pdf
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1、 Reference number ISO 20795-1:2008(E) ISO 2008 INTERNATIONAL STANDARD ISO 20795-1 First edition 2008-08-01 Dentistry Base polymers Part 1: Denture base polymers Art dentaire Polymres de base Partie 1: Polymres pour base de prothses dentaires Copyright International Organization for Standardization P
2、rovided by IHS under license with ISO Licensee=Boeing Co/5910770001 Not for Resale, 10/25/2008 04:50:32 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 20795-1:2008(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing polic
3、y, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. The ISO Central S
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5、 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 reserved. Unless otherwise specified, no part of this publi
6、cation 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 requester. ISO copyright office Case postale 56 CH-1211 Genev
7、a 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 ISO Licensee=Boeing Co/5910770001 Not for Resale, 10/25/2008
8、04:50:32 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 20795-1:2008(E) ISO 2008 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 2 4 Classification. 3 5 Requirements 4 5.1 Unpolymerized mat
9、erial . 4 5.2 Polymerized material 4 6 Sampling 6 7 Preparation of test specimens 7 7.1 Laboratory environment 7 7.2 Procedures 7 7.3 Special equipment 7 8 Test methods. 7 8.1 Inspection for compliance determination 7 8.2 Packing plasticity 8 8.3 Colour 10 8.4 Colour stability 10 8.5 Polishability,
10、translucency, freedom from porosity, ultimate flexural strength and flexural modulus. 12 8.6 Fracture toughness with a modified bending test 17 8.7 Bonding to synthetic polymer teeth . 22 8.8 Residual methyl methacrylate monomer 23 8.9 Water sorption and solubility 28 9 Requirements for labelling, m
11、arking, packaging and instructions supplied by the manufacturer. 30 9.1 Packaging 30 9.2 Marking of outer packages and containers . 30 9.3 Manufacturers instructions 31 Annex A (normative) HPLC method for determination of MMA content 33 Bibliography. 36 Copyright International Organization for Stand
12、ardization Provided by IHS under license with ISO Licensee=Boeing Co/5910770001 Not for Resale, 10/25/2008 04:50:32 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 20795-1:2008(E) iv ISO 2008 All rights reserved Foreword ISO (the International Organization for Standardi
13、zation) 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 which a technical committee has been established has the right to b
14、e 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 all matters of electrotechnical standardization. International Standa
15、rds 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 circulated to the member bodies for voting. Publication as an Inter
16、national 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 responsible for identifying any or all such patent rights. ISO 20795-1
17、 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials. This first edition cancels and replaces ISO 1567:1999 and Amendment 1:2003. Significant differences between this first edition of ISO 20795-1 and the third edition of ISO 1567 and Amendment 1 lie
18、with requirements and tests for materials with improved impact resistance. ISO 20795 consists of the following parts, under the general title Dentistry Base polymers: Part 1: Denture base polymers Part 2: Orthodontic base polymers Copyright International Organization for Standardization Provided by
19、IHS under license with ISO Licensee=Boeing Co/5910770001 Not for Resale, 10/25/2008 04:50:32 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 20795-1:2008(E) ISO 2008 All rights reserved v Introduction Specific qualitative and quantitative requirements for freedom from b
20、iological hazard are not included in this part of ISO 20795, but it is recommended that in assessing possible biological or toxicological hazards, reference be made to ISO 10993-1 and ISO 7405. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=B
21、oeing Co/5910770001 Not for Resale, 10/25/2008 04:50:32 MDTNo reproduction or networking permitted without license from IHS -,-,- Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Boeing Co/5910770001 Not for Resale, 10/25/2008 04:50:32 MDTNo re
22、production or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARD ISO 20795-1:2008(E) ISO 2008 All rights reserved 1 Dentistry Base polymers Part 1: Denture base polymers 1 Scope 1.1 This part of ISO 20795 classifies denture base polymers and copolymers and specifies their req
23、uirements. It also specifies the test methods to be used in determining compliance with these requirements. It further specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for use of these materials. Furthermore it applies to denture base p
24、olymers for which the manufacturer claims that the material has improved impact resistance. It also specifies the respective requirement and the test method to be used. 1.2 Although this part of ISO 20795 does not require manufacturers to declare details of the composition, attention is drawn to the
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