BS ISO 6474-1-2010 en_1881 Implants for surgery - Ceramic materials - Ceramic materials based on high purity alumina《外科植入物.陶瓷材料.高纯氧化铝基陶瓷材料》.pdf

1、BS ISO 6474-1:2010 ICS 11.040.40 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BRITISH STANDARD Implants for surgery Ceramic materials Part 1: Ceramic materials based on high purity aluminaThis British Standard was published under the authority of the Standards Policy and St

2、rategy Committee on 28 February 2010 BSI 2010 ISBN 978 0 580 65051 2 Amendments/corrigenda issued since publication Date Comments BS ISO 6474-1:2010 National foreword This British Standard is the UK implementation of ISO 6474-1:2010. It supersedes BS 7253-2:1997, which will be withdrawn on publicati

3、on of BS ISO 6474-2. The UK participation in its preparation was entrusted to Technical Committee CH/150/1, Materials for surgical implants. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessa

4、ry provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations.BS ISO 6474-1:2010Reference number ISO 6474-1:2010(E) ISO 2010INTERNATIONAL STANDARD ISO 6474-1 First edition 2010-02-15 Implants for surge

5、ry Ceramic materials Part 1: Ceramic materials based on high purity alumina Implants chirurgicaux Produits cramiques Partie 1: Produits cramiques base dalumine de haute puret BS ISO 6474-1:2010 ISO 6474-1:2010(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes

6、licensing policy, 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. Th

7、e 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 parameters were optimized for printing. Every care ha

8、s 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 2010 All rights reserved. Unless otherwise specified, no par

9、t 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 requester. ISO copyright office Case postale 5

10、6 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 2010 All rights reservedBS ISO 6474-1:2010 ISO 6474-1:2010(E) ISO 2010 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normative referen

11、ces1 3 Classification .3 3.1 Material types.3 3.2 Test categories 3 3.3 Material properties 3 4 Preparation of specimens.5 5 Test methods .5 5.1 Bulk density .5 5.2 Chemical composition 5 5.3 Microstructure .5 5.4 Determination of strength properties6 5.5 Youngs modulus.7 5.6 Fracture toughness.7 5.

12、7 Hardness 7 5.8 Wear7 5.9 Cyclic fatigue .8 6 Test report8 Bibliography9 BS ISO 6474-1:2010 ISO 6474-1:2010(E) iv ISO 2010 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of pre

13、paring 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 be represented on that committee. International organizations, governmental and non-governmental, in

14、 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 Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task

15、 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 International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention

16、 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 6474-1 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1, Materials.

17、 This first edition, together with ISO 6474-2, cancels and replaces ISO 6474:1994, which has been technically revised. ISO 6474 consists of the following parts, under the general title Implants for surgery Ceramic materials: Part 1: Ceramic materials based on high purity alumina Part 2: Composite ma

18、terials based on a high purity alumina matrix with zirconia reinforcement BS ISO 6474-1:2010 ISO 6474-1:2010(E) ISO 2010 All rights reserved vIntroduction No known surgical implant material has ever been shown to be completely free of adverse reactions in the human body. However, long-term clinical

19、experience of use of the material referred to in ISO 6474 has shown that an acceptable level of biological response can be expected, when the material is used in appropriate applications. BS ISO 6474-1:2010BS ISO 6474-1:2010 INTERNATIONAL STANDARD ISO 6474-1:2010(E) ISO 2010 All rights reserved 1Imp

20、lants for surgery Ceramic materials Part 1: Ceramic materials based on high purity alumina 1 Scope This part of ISO 6474 specifies the characteristics of, and corresponding test methods for, a bio-compatible and bio-stable ceramic bone substitute material based on high purity alumina for use as bone

21、 spacers, bone replacements and components of orthopaedic joint prostheses. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the refere

22、nced document (including any amendments) applies. ISO 31 (all parts), Quantities and units ISO 12677, Chemical analysis of refractory products by X-ray fluorescence (XRF) Fused cast-bead method ISO 13356, Implants for surgery Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) I

23、SO 14704, Fine ceramics (advanced ceramics, advanced technical ceramics) Test method for flexural strength of monolithic ceramics at room temperature ISO 14705, Fine ceramics (advanced ceramics, advanced technical ceramics) Test method for hardness of monolithic ceramics at room temperature ISO 1573

24、2, Fine ceramics (advanced ceramics, advanced technical ceramics) Test method for fracture toughness of monolithic ceramics at room temperature by single edge precracked beam (SEPB) method ISO 17561, Fine ceramics (advanced ceramics, advanced technical ceramics) Test method for elastic moduli of mon

25、olithic ceramics at room temperature by sonic resonance ISO 18754, Fine ceramics (advanced ceramics, advanced technical ceramics) Determination of density and apparent porosity ISO 18756, Fine ceramics (advanced ceramics, advanced technical ceramics) Determination of fracture toughness of monolithic

26、 ceramics at room temperature by the surface crack in flexure (SCF) method ISO 20501, Fine ceramics (advanced ceramics, advanced technical ceramics) Weibull statistics for strength data ISO 22214, Fine ceramics (advanced ceramics, advanced technical ceramics) Test method for cyclic bending fatigue o

27、f monolithic ceramics at room temperature BS ISO 6474-1:2010 ISO 6474-1:2010(E) 2 ISO 2010 All rights reservedISO 23146, Fine ceramics (advanced ceramics, advanced technical ceramics) Test methods for fracture toughness of monolithic ceramics Single-edge V-notch beam (SEVNB) method EN 623-2, Advance

28、d technical ceramics Monolithic ceramics General and textural properties Part 2: Determination of density and porosity EN 623-3, Advanced technical ceramics Monolithic ceramics General and textural properties Part 3: Determination of grain size and size distribution (characterized by the Linear Inte

29、rcept Method) EN 843-1, Advanced technical ceramics Mechanical properties of monolithic ceramics at room temperature Part 1: Determination of flexural strength EN 843-2, Advanced technical ceramics Mechanical properties of monolithic ceramics at room temperature Part 2: Determination of Youngs modul

30、us, shear modulus and Poissons ratio EN 843-4, Advanced technical ceramics Mechanical properties of monolithic ceramics at room temperature Part 4: Vickers, Knoop and Rockwell superficial hardness EN 843-5, Advanced technical ceramics Mechanical properties of monolithic ceramics at room temperature

31、Part 5: Statistical analysis CEN/TS 14425-5, Advanced technical ceramics Test methods for determination of fracture toughness of monolithic ceramics Part 5: Single-edge vee-notch beam (SEVNB) method ASTM C1161, Standard Test Method for Flexural Strength of Advanced Ceramics at Ambient Temperature AS

32、TM C1198, Standard Test Method for Dynamic Youngs Modulus, Shear Modulus, and Poissons Ratio for Advanced Ceramics by Sonic Resonance ASTM C1239, Standard Practice for Reporting Uniaxial Strength Data and Estimating Weibull Distribution Parameters for Advanced Ceramics ASTM C1259, Standard Test Meth

33、od for Dynamic Youngs Modulus, Shear Modulus, and Poissons Ratio for Advanced Ceramics by Impulse Excitation of Vibration ASTM C1327, Standard Test Method for Vickers Indentation Hardness of Advanced Ceramics ASTM C1331, Standard Test Method for Measuring Ultrasonic Velocity in Advanced Ceramics wit

34、h Broadband Pulse-Echo Cross-Correlation Method ASTM C1421, Standard Test Methods for Determination of Fracture Toughness of Advanced Ceramics at Ambient Temperature ASTM C1499, Standard Test Method for Monotonic Equibiaxial Flexural Strength of Advanced Ceramics at Ambient Temperature ASTM E112, St

35、andard Test Methods for Determining Average Grain Size BS ISO 6474-1:2010 ISO 6474-1:2010(E) ISO 2010 All rights reserved 33 Classification 3.1 Material types The material shall be classified as either type A or type B. Ceramic materials of type A are intended for implants for high load applications

36、 (e.g. bearing surfaces of joint replacements). Type B is intended for implants for low load applications (e.g. maxillofacial and middle-ear implants). 3.2 Test categories 3.2.1 General The required tests shall be distinguished in category 1 and category 2. The tests in 5.6, 5.8 and 5.9 shall only b

37、e applied for type A materials. 3.2.2 Category 1: required tests representative for the periodical production control The following tests shall be performed for periodical production control: a) bulk density; b) chemical composition; c) microstructure; d) strength. 3.2.3 Category 2: required tests r

38、epresentative for the general material specification The manufacturer shall define the general material specification. In addition to all tests in 3.2.2, the following tests shall be performed for the qualification of the material specification: a) Youngs modulus; b) fracture toughness; c) hardness;

39、 d) wear resistance; e) fatigue limit. 3.3 Material properties To fulfil the requirements of this part of ISO 6474, the material shall meet the limits for properties as given in Table 1. Documentation of the test results shall be according to the International System of Units (SI), ISO 31. BS ISO 64

40、74-1:2010 ISO 6474-1:2010(E) 4 ISO 2010 All rights reservedTable 1 Limits for material properties Requirement Property Unit Property category Type A Type B Subclause References Average bulk density kg/m 3 10 31 W 3,94 W 3,90 5.1 ISO 18754 EN 623-2 Chemical composition: Basic material, Al 2 O 3% mass

41、 fraction 1 W 99,7 W 99,5 Sintering additive, MgO % mass fraction 1 u 0,2 u 0,2 5.2 ISO 12677 Limits of impurities, total amount of SiO 2+ CaO + Na 2 O % mass fraction 1 u 0,1 u 0,3 Microstructure: EN 623-3 Linear intercept grain size m 1 u 2,5 u 3,5 5.3 ASTM E112 Standard deviation % 1 u 25 u 25 IS

42、O 13356 Material strength; alternatives 1) or 2): 5.4 1a) Mean biaxial flexural strength MPa 1 W 300 W 150 5.4.2 ASTM C1499 1b) Weibull modulus - 1 W 8 W 8 5.4.4 ISO 20501 EN 843-5 ASTM C1239 2a) Mean 4-point flexural strength MPa 1 W 500 W 250 5.4.3 ISO 14704 EN 843-1 ASTM C1161 2b) Weibull modulus

43、 - 1 W 8 W 8 5.4.4 ISO 20501 EN 843-5 ASTM C1239 Youngs modulus GPa 2 W 380 W 370 5.5 ISO 17561 EN 843-2 ASTM C1331 ASTM C1198 ASTM C1259 Fracture toughness, alternatives 1) to 3) 5.6 1) SEVNB MPa m 2 W 2,5 n.a. 5.6.2 ISO 23146 CEN/TS 14425-5 2) SEPB MPa m 2 W 2,5 n.a. 5.6.3 ISO 15732 3) SCF MPa m 2

44、 W 2,5 n.a. 5.6.4 ISO 18756 ASTM C1421 Average hardness, Vickers HV1 GPa 2 W 18 W 17 5.7 ISO 14705 EN 843-4 ASTM C1327 Wear resistance 2 Info n.a. 5.8 e.g. ISO 14242-1 Cyclic fatigue: 10 million cycles endurance limit strength in 4-point bending MPa 2 No failure at 200 MPa n.a. 5.9 ISO 22214 BS ISO

45、6474-1:2010 ISO 6474-1:2010(E) ISO 2010 All rights reserved 54 Preparation of specimens Specimens shall be produced equivalent to the regular production of the implants. The same feedstock, comparable shaping technology (e.g. axial pressing, isostatic pressing), high temperature process (e.g. sinter

46、ing, hot isostatic pressing) and hard machining (e.g. grinding, polishing) shall be applied. The shaping of specimens shall be accomplished according to the requirements of the test. The manufacturer shall declare and justify whether the production of the specimens can be assessed as equivalent to t

47、he regular production. Finished products or portions of them can be used for the evaluation of material properties. However, due to geometric restrictions and the risk of damage during specimen preparation, it is not recommended to produce specimens as portions of finished products for evaluation of

48、 the following material properties: a) strength (see 5.4); b) fracture toughness (see 5.6); c) cyclic fatigue (see 5.9). 5 Test methods 5.1 Bulk density The bulk density shall be determined in accordance with ISO 18754. NOTE An equivalent procedure can be found in EN 623-2. 5.2 Chemical composition

49、The chemical composition shall be determined either by X-ray fluorescence in accordance with ISO 12677 or by induced coupled plasma (ICP) emission spectroscopy. 5.3 Microstructure For determination of the alumina grain size, EN 623-3 or ASTM E112 shall be applied (linear intercept method). NOTE The linear intercept method reveals a nominal average grain size for the selected position of the micrograph, not the distribution of the size of individual gra