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1、J IS JAPANESE I NDUSTRIAL STANDARD Translated and Published by Japanese Standards Association JIS T 7401-6 :zoo2 Titanium materials for surgical implant ap pl cat ions Part 6 : Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy ICs 11.040.40; 77.150.50 Reference number : JIS T 7401-6 : 200
2、2 (E) PROTECTED BY COPYRIGHT 4s Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/10/2007 19:10:30 MSTNo reproduction or networking permitted without license from IHS -,-,- T 7401-6 2002 Foreword Thi
3、s translation has been made based on the original Japanese Industrial Standard established by the Minister of Health, Labour and Welfare, and Minister of Economy, Trade and Industry through deliberations at the Japanese Industrial Standards Committee according to the proposal of establishing a Japan
4、ese Industrial Standard from the Japanese Society for Biomaterials (JSB), with a draft of Industrial Standard based on the provision of Article 12 Clause 1 of the Industrial Standardization Law. Attention is drawn to the possibility that some parts of this Standard may conflict with a patent right,
5、application for a patent after opening to the public, utility model right or application for registration of utility model after opening to the public which have technical properties. The relevant Ministers and the Japanese Industrial Standards Committee are not responsible for identifying the paten
6、t right, application for a patent after opening to the public, utility model right or application for registration of utility model after opening to the public which have the said technical properties. JIS T 7401 series consist of the following six parts with the general title of Titanium materials
7、for surgical implant applications. Part 1 : Unalloyed titanium Part 2 : Wrought titanium 6-aluminium 4-vanadium alloy Part 3 : Wrought titanium 6-aluminium 2-niobium 1-tantalum alloy Part 4 : Wrought titanium 15-zirconium 4-niobium 4-tantalum alloy Part 5 : Wrought titanium 6-aluminium 7-niobium all
8、oy Part 6 : Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy Date of Establishment: 2002-03-25 Date of Public Notice in Official Gazette: 2002-03-25 Investigated by: Japanese Industrial Standards Committee Standards Board Technical Committee on Medical Equipment JIS T 7401-6 : 2002, Firs
9、t English edition published in 2002-12 Translated and published by: Japanese Standards Association 4-1-24, Akasaka, Minato-ku, Tokyo, 107-8440 JAPAN In the event of any doubts arising as to the contents, the original JIS is to be the final authority. O JSA 2002 All rights reserved. Unless otherwise
10、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 the publisher. Printed in Japan PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provide
11、d by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/10/2007 19:10:30 MSTNo reproduction or networking permitted without license from IHS -,-,- JAPANESE INDUSTRIAL STANDARD JIS T 7401-6 : 2002 Titanium materials for surgical implant applications Part
12、 6 : Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy 1 Scope This Japanese Industrial Standard specifies the characteristics of, and corresponding test methods for, the wrought titanium alloy known as titanium 15- molybdenum 5-zirconium 3-aluminium alloy (Ti-15Mo-5Zr-3Al) for use in the
13、 manu- facture of surgical implants, especially its chemical composition, metallic properties, mechanical properties and internal properties. It is required to use this alloy clini- cally after investigating the safety corresponding to the environment where implants are used. The mechanical properti
14、es of a sample obtained from a finished product made of this alloy may not necessarily comply with those specified in this Standard. 2 Normative references The following standards contain provisions which, through reference in this Standard, constitute provisions of this Standard. The most recent ed
15、itions of the standards (including amendments) indicated below shall be applied. JIS H 0321 General rules for inspection of non-ferrous metal materials JIS H 1610 Titanium and titanium alloys-Sampling methods JIS H 1611 Titanium and titanium alloys-General rules for chemical analysis JIS H 1612 Meth
16、ods for determination of nitrogen in titanium and titanium alloys JIS H 1614 Methods for determination of iron in titanium and titanium alloys JIS H 1617 Methods for determination of carbon in titanium and titanium alloys JIS H 1619 Methods for determination of hydrogen in titanium and titanium allo
17、ys JIS H i620 Methods for determination of oxygen in titanium and titanium alloys JIS H 1622 Titanium alloys-Methods for determination of aluminium JIS H 1630 Method for atomic emission spectrometric analysis of titanium JIS T 0301 Testing method for biocompatibility of implantable metals using cul-
18、 tured cells Testing method for corrosion resistance of metallic hiomaterials by anodic polarization measurement JIS Z 2201 Test pieces for tensile test for metallic materials JIS Z 2204 Bend test pieces for metallic materials JIS Z 2241 Method of tensile test for metallic materials JIS Z 2248 Metho
19、d of bend test for metallic materials ASTM E 120 1996 JIS T 0302 Standard test method for chemical analysis of titanium and titanium alloys 3 Definitions 0301 and JIS T 0302, and the following definitions apply. For the purposes of this Standard, the definitions given in JIS T PROTECTED BY COPYRIGHT
20、 Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/10/2007 19:10:30 MSTNo reproduction or networking permitted without license from IHS -,-,- 2 T 7401-6 : 2002 Mo 14.0 to 16.0 a) surgical implant Med
21、ical equipment for surgery used by embedding under skins, into muscles or bone structure for supplementing the function of the body. b) fl transformation temperature A temperature which phase transformation to p has been finished. Zr Al Fe O C N H Ti 4.5 2.5 0.35 0.20 0.05 0.05 0.02 Remainder to to
22、max. max. max. max. max. 5.5 3.5 4 Qualities Form of alloy Tensile test Tensile Proof Elongation Reduction strength stress after fracture of area min. min. min. min. MPa MPa % % Sheet/strip 940 900 10 - Bar 940 900 12 25 4.1 mental defects to use. Appearance The appearance shall be good-finished and
23、 be free from detri- Bend test (I) Bending Inside radius angle O mm 105 Thickness x 10 - - 4.2 Chemical composition The chemical composition, when determined as specified in 5.1, shall conform to the requirements in Table 1. Table 1 Chemical composition I Chemical composition % I 4.3 be uniform. Mic
24、rostructure The microstructure, when examined as specified in 5.2, shall 4.4 Mechanical properties The mechanical properties (tensile strength, proof stress, elongation after fracture, reduction of area and bend), when examined as specified in 5.3 and 5.4, shall conform to Table 2. 4.5 shall be free
25、 from detrimental defects to use such as flaws. Internal properties When tested according to 5.5, the internal properties 5 Test methods 5.1 The chemical analysis of chemical composition shall be carried out according to the following. However, for molybdenum and zirconium, the most suitable method
26、shall be selected among those for other elements. Chemical analysis PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/10/2007 19:10:30 MSTNo reproduction or networking permitte
27、d without license from IHS -,-,- 3. T 7401-6 : 2002 JIS H 1611, JIS H 1612, JIS H 1614, JIS H 1617, JIS H 1619, JIS H 1620, JIS H 1622, JIS H 1630 Information : The chemical analysis can be made according to ASTM E 120 : 1996 Standard test method for chemical analysis of titanium and tita- nium allo
28、ys. 5.2 Observation of microstructure Observe microstructure using an optical mi- croscope of magnification 100 to 400 times. The heat treatment shall be carried out at the p transformation temperature or lower and retain for the most suitable time, then cool rapidly. 5 . 3 Tensile test The tensile
29、test shall be carried out according to JIS Z 2241. In this case, the test pieces shall be No. 4, No. 5 or No. 13B of JIS Z 2201. In the proof stress measurement, the strain increase rate of gauge length shall be 0.3 to 0.7 %/min, and also a test with increasing the strain increase rate to frac- ture
30、 in a short time may be carried out after the proof stress point has been over (for example about 10 %/min). 5.4 The bend test shall be carried out according to JIS Z 2248. The test pieces shall be No, 3 of JIS Z 2204, and after bend test, there shall be no cracks outside the bent portion. Bend test
31、 5.5 Internal properties test A non-destructive testing machine shall be used for the internal properties test, and the test method is subject to the agreement be- tween the parties concerned. 6 Inspection a) The inspection shall be according to JIS H 0321 and the following. Samples of chemical anal
32、ysis shall be taken from the same lots from one ingot which are subjected to the same heat treatment according to JIS H 1610, so that impurities dont get mixed with. However, the analytic values shall be those after heat-treated for hydrogen, and for the composition other than hy- drogen, the analyt
33、ic values of ingots may be representative. Test pieces of tensile test and bend test shall be taken from the same lots from one ingot which are subjected to the same heat treatment, having the same thickness and if possible, test shall be carried out at least twice under the same test conditions. b)
34、 c) Materials shall be inspected on appearance and dimensions and shall conform to clause 4 when tested according to clause 5. If not conformed, retest shall be carried out according to clause 7 of JIS H 0321. 7 Marking Materials shall be marked the following information on a product or a package by
35、 suitable method. a) Name of material b) Dimensions c) Manufacturers name or abbreviation d) Manufacture number or symbol PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/10/2
36、007 19:10:30 MSTNo reproduction or networking permitted without license from IHS -,-,- Emta for JIS (English edition) are prbted in Standurdization Journal, pubshed monthly by the Japanese Standards Association, and also provided to subscribers of JS (English edition) in Monthly Information. Errata
37、wili be provided upon request, please contact: Standarization Promotion Departme& Japanese Standards Association 4-1-24, Akasaka, Minato-ku, Tokyo, 107-8440 JAPAN TEL. 03-3583-8002 FAX. 03-3583-0462 100% Recycled paper PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/10/2007 19:10:30 MSTNo reproduction or networking permitted without license from IHS -,-,-
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