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1、STD.IS0 1335b-ENGL 1797 4853703 072325b O80 m INTERNATIONAL STANDARD IS0 13356 First edition 1997-09- 1 5 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) Implants chirurgicaux - Produits cramiques a base de zircone trragonale stabilise a iyttrium (Y-TZ
2、P) This material is reproduced from IS0 documents under International Organization for Standardization (ISO) Copyright License number IHSllCCl1996. Not for resale. No part of these IS0 documents may be reproduced in any form, electronic retrieval system or otherwise, except as allowed in the copyrig
3、ht law of the country of use, or with the prior written consent of IS0 (Case postale 56,1211 Geneva 20, Switzerland, Fax +41 22 734 10 79), IHS or the IS0 Licensors members. Reference number IS0 13356:1997(E) STDSISO 13356-ENGL 1997 I 4851903 0723257 TL7 IS0 1 3356: 1 997( E) Foreword IS0 (the Inter
4、national Organization for Standardization) is a worldwide federation of national standards bodies (IS0 member bodies). The work of preparing International Standards is normally carried out through IS0 technical committees. Each member body interested in a subject for which a technical committee has
5、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. IS0 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical st
6、andardization. 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 member bodies casting a vote. International Standard IS0 13356 was prepared by Technical
7、 Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1, Materiais. Annex A of this Intemational Standard is for information only. 8 IS0 1997 All rights reserved. UnleSS otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or m
8、echanical, including PhotOCOpying and microfilm, without pemission in writing from the publisher. Intemational Organization for Standardization Case Postale 56 CH-1211 Genve 20 e Switzerland Internei centraiiso.ch X.400 c=ch; a400net; p=iso; o=isocs; s=central Printed in Switzerland -,-,- o IS0 Intr
9、oduction No known surgical implant material has ever been shown to cause absolutely no adverse reactions in the human body. However, long-term clinical experience of the use of the material referred to in this International Standard has shown that an acceptable level of biological response can be ex
10、pected when the material is used in appropriate applications. . 111 -,-,- STD-IS0 1335b-ENGL 1997 4853903 0723257 89T I INTERNATIONAL STANDARD 0 IS0 IS0 13356:1997(E) Implants for surgery - Ceramic materials based on yttria- stabilized tetragonal zirconia (Y-TZP) 1 Scope This International Standard
11、specifies the characteristics of, and corresponding test method for, a biocompatible and biostabk ceramic bow-substitute (material based on yttria-stabilized tetragonal zirconia (yttria tetragonal zirconia putycrystal, Y-TZP) for use as material for surgical implants. 2 Normative references The foll
12、owing standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this International Standard are enc
13、ouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and IS0 maintain registers of currently valid International Standards. IS0 361 1 :1978, Micrometer callipers for external measurement. IS0 501 7:-), Dense shaped refractory pr
14、oducts - Determination of bulk density, apparent porosity and true porosity. EN 843-1 :1995, Advanced technical ceramics - Monolithic ceramics - Mechanical properties at room fempera- fure - fart 7: Determination of f/exura/ strength. ASTM E 1 12:1995, Estimating the average grain size of metals. AS
15、TM C 323:1956( 1995), Test methods for chemical analysis of ceramic witheware clays. ASTM C 373:1988, Test method for water absorption, bulk density, apparent porosity and apparent specific gravity of fired witheware products. ASTM C 573:1981(1990), Chemical analysis of fireclay and high-alumina ref
16、ractories. ASTM C 1 1 61 : 1 990, Determination of the strength of advanced ceramics in #-point bending. NOTE - The ASTM references will be replaced by reference to appropriate International Standards when the latter become available. 3 Physical and chemical properties The physical and chemical prop
17、erties, when tested as specified in clause 4, shall comply with the values specified in table 1. 1) To be published. (Revision of IS0 5017:1988) 1 -,-,- STD-IS0 2335b-ENGL 1997 m 4852703 07232b0 501 m Is0 13356:1997(E) Table 1 - Physical and chemical properties Property Bulk density Chemical composi
18、tion: Zr02 + Hf02 + Y203 2 3 Hf203 Other oxides Microstructure: Mean linear intercept distance Strength 1: Biaxial flexure 4-point bending or Unit gicm3 percent mass fraction MPa I) Measured on a minimum of 10 samples. Requirement 3 6,OO 99,o 4,5 to 5,4 G 5 HV 500 or HRC 40) in order to minimize dam
19、age or roughness caused by fracture of the test pieces; In order to accommodate slight departures from surface flatness of the test pieces, a (0,6 I 0,l) mm thick rubber plate with a Shore hardness of 60 f 5 shall be placed between the support ring and the test piece, and a piece of paper shall be p
20、laced between the test piece and the loading ring. 3 IS0 13356:1997(E) 4.4.2.3 Micrometer, in accordance with IS0 361 1, capable of measuring to an accuracy of k 0,Ol mm. F Loading ring 1 Rubber plate 1 ; Support ring 1 o IS0 Figure 1 - Schematic diagram of the biaxial flexure testing device employi
21、ng concentric loading and support rings 4.4.3 Preparation of test piece Prepare billets or discs of the zirconia ceramic using methods representative of the method of production of parts for surgery, using the same precursor powder, pressing technique and pressure and firing conditions; Test pieces
22、(see figure 1) shall be circular plates of diameter (36,O f 1 ,O) mm and thickness (2,O k 0,l) mm. The surface to be tested shall be in the as-fired state; At least 10 test pieces shall be prepared for determination of mean strength, or at least 30 test pieces if a Weibull statistical analysis is re
23、quired. 4 -,-,- 0 IS0 STD-IS0 3335b-ENGL L977 4853903 07232b3 2LU I IS0 13356:1997(E) 4.4.4 Procedure Measure the diameter of the test piece to the nearest 0,l mm and the thickness to the nearest 0,Ol mm, each in at least three random positions. Calculate the mean diameter and mean thickness. Place
24、the rubber sheet on the support ring of the test jig. Place the test piece on the rubber sheet, with the surface to be tested in contact with the rubber, and centre it. Place a paper disc on the top of the test piece, place the loading ring on the paper and centre it relative to the test piece and s
25、upport ring. Apply a steadily increasing compressive force to the jig at a loading rate of (500 f 100) N/s until the test piece fractures. Record the load at fracture. Inspect the fragments for evidence of the failure origin. If this is more than 0,5 mrn outside the inner loading ring, note this fac
26、t in the report (4.4.6). For the purposes of calculation of the fracture stress, assume failure within the inner loading ring. Do not discard the result in calculating the mean strength of the test batch. Repeat the procedure for each test piece in the batch. 4.4.5 Calculation of results For each te
27、st piece, calculate the nominal fracture stress, o, in MPa, as: where F is the force applied at fracture, in newtons; t is the mean test piece thickness, in millimetres; d, is the support ring mean (contact) diameter, millimetres: dl is the loading ring mean (contact) diameter, in millimetres; d is
28、the test piece diameter, in millimetres; v is Poissons ratio for zirconia (assume to be 0,3). Calculate the mean fracture stress and the standard deviation for the batch of test pieces. 4.4.6 Test report The test report shall contain at least the following information. a) The identity of the ceramic
29、 material, details of batch number or other codes sufficient to uniquely identify the test pieces; b) method of preparing the test pieces; c) mean value and standard deviation of the fracture stresses. If appropriate, the individual fracture stresses of the series of test pieces as well as Weibull s
30、tatistical data may be given. The position of failure of test pieces shall be reported if this appears to fall outside the loading ring diameter (see 4.4.4). 4.5 4-point bending strength The 4-point bending strength shall be determined in accordance with ASTM C 11 6 1 or EN 843-1 5 IS0 13356:1997(E)
31、 o IS0 The test pieces shall be a 45 mm in length (4,O f 0,2) mm in width and (3,O f 0,2) mm in thickness. The test piece is supported by two parallel rollers of diameter (50 i 0,2) mm. The two rollers shall be positioned symmetrically with respect to the length of the test piece with their centres
32、(40 f0,5) mm apart (outer span). The two loading rollers shall be symmetrically located with respect to the outer roller and shall have a span of (20 f 0,2) mm. 6 -,-,- o IS0 STD=ISO L335b-ENGL 1997 D 4851903 07232b5 073 6 IS0 1 3356: 1 997( E) Annex A (informative) Bibliography l IS0 7500-1 :1986,
33、Metallic materials - Verification of static uniaxial testing machine - Part I : Tensile testing 2 EN 623-2:1993, Advanced technical ceramics - Monolithic ceramics - General and textural properties - machines. Part 2: Determination of density and porosity. 7 STD-IS0 1335b-ENGL 1797 ?4853903 07232bb T2T i l l IS0 13356: 1 997( E) ICs 1 1.040.40 Descriptors: medical equipment, Special ceramics, surgical implants, specifications, physical properties, chemical properties, radioactivity, tests, determination, chemical composition, microstructure, flexural strength. Price based on 7 pages -,-,-