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1、INTERNATIONAL STANDARD 7206-2 Second edition 1996-06-0 1 Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials Implan ts chirurgicaux - Pro theses partielles et totales de I artkula tion de Ia hanche - Partie 2:
2、 Surfaces artkulakes cons titu6es de ma tkriaux m6 talliques, Mamiques et plastiques Reference number ISO 7206-2:1996(E) 1550 7206-2: 1996(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national Standards bodies (ISO member bodies). The work of prep
3、aring International Standards is normally carried out through ISO . technical committees. Esch member body interested in a subject for which a technical committee has been established has the right to be rep- resented on that committee. International organizations, governmental and non-governmental,
4、 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. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Pu
5、blication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. International Standard ISO 7206-2 was prepared by Technical Committee lSO/TC 150, Implants for surgery, Subcommittee SC 4, Bone and joint replacemen ts. This second edition cancels and repl
6、aces the first edition (ISO 72062:1987), which has been technically revised. ISO 7206 consists of the following Parts, under the general title Implants for surgety - Partial and total hip join t pros theses: - Part 1: Classification and designation of dimensions - Part 2: Articulating surfaces made
7、of metallic, ceramic and plastics ma terials - Part 3: Determination of endurante properties of stemmed femora componen ts without applica tion of torsion - Part 4: Determination of endurante properties of stemmed femora componen ts with applica tion of torsion - Part 5: Determination of resis tance
8、 to s region of s temmed fernoral componen ts tatic load of and neck - Part 6: Determination of endurante properties of head and neck region of stemmed fernoral components 0 ISO 1996 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any for
9、m or by any means, electronie or mechanical, including photocopying and microfilm, without Permission in writing from the publisher. International Organization for Standardization Case postale 56 l CH-l 211 Geneve 20 l Switzerland Printed in Switzerland ii -,-,- ISO ISO 7206-2: 1996(E) - Part 7: End
10、urante Performance of stemmed fernoral components without application of torsion - Part 8: Endurante Performance of stemmed fernoral components with application of torsion - Part 9: Determination of resis tance to torque of head fixa tion of stemmed fernoral componen ts Annex A forms an integral par
11、t of this part of ISO 7206. -,-,- This page intentionally left blank -,-,- INTERNATIONAL STANDARD 0 ISO ISO 7206-2: 1996(E) Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials 1 Scope This part of ISO 7206 spe
12、cifies requirements for the articulating surfaces of those types of total and partial hip joint prostheses that provide a joint replacement of ball and socket configuration, as follows: a) sphericity and surface finish requirements for metallic and ceramic fernoral prostheses for par- tial hip joint
13、 replacement that are in accordance with classification a) of ISO 7206-1; b) sphericity and surface finish requirements for bipolar heads with plastics inner surfaces which articulate on fernoral components that are in ac- cordante with classification a) of ISO 7206-1 and with metallic or ceramic ou
14、ter surfaces which ar- ticulate on the biological acetabulum; c) sphericity and surface finish requirements and dimensional tolerantes for plastics acetabular components that are in accordance with classifi- cation b) of ISO 7206-1; d) sphericity and surface finish requirements and dimensional toler
15、antes for metallic or ceramic fernoral components of total hip joint prostheses that are in accordance with classification c) of ISO 7206-1, designed to articulate on plastics acetabular components. part of ISO 7206 are encouraged to investigate the possibility of applying the most recent editions o
16、f the Standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 468:1982, Surface roughness - Parameters, their values and general wies for specifying require- men ts. ISO 7206-1: 1995, Implants for surgery - Partial and total hip joint pros
17、theses - Part 1: Classification and designa tion of dimensions. 3 Definitions For the purposes of this part of ISO 7206, the defi- nitions given in ISO 7206-1 apply. 4 Requirements 4.1 Fernoral components of total hip joint prostheses NOTE 1 This subclause refers to spherical articulating surfaces o
18、f fernoral components of total joint hip pros- theses in accordance with classification c) of ISO 7206-1. 2 Normative references 4.1.1 Sphericity The following Standards contain provisions which, through reference in this text, constitute provisions of this part of ISO 7206. At the time of publicati
19、on, the editions indicated were valid. All Standards are subject to revision, and Parties to agreements based on this When measured in accordance with the method given in A.l, the departure from sphericity of the spherical articulating surface of a fernoral component shall have a radial Separation v
20、alue not greater than 10 um. ISO 7206-2: 1996(E) ISO 4.1.2 Sutface finish to + 0,3 mm at a temperature of 20 “C + 2 “C (i.e. it shall be oversized within the given tolerante). When measured in accordance with the principles given in ISO 468, the spherical articulating surfaces of metallic and cerami
21、c components shall have R, values not greater than 0,05 um and 0,02 um respectively, using a cutoff value of 0,08 mm. The following details should be reported: 4.3 Fernoral prostheses for partial joint replacements NOTE 3 This subclause refers to spherical articulating surfaces of fernoral prosthese
22、s for partial joint replace- ments in accordance with classification a) of ISO 7206-1. a) stylus tip radius; b) 4.3.1 Sphericity Position of measurement on specimen. When examined by normal or corrected Vision, the articulating surface shall be free from embedded particles and from scratches and Sco
23、re marks other than those arising from the finishing process. When measured in accordance with the method given in A.1, the departure from sphericity of the spherical articulating surface shall have a radial Separation value no greater than 100 um. 4.3.2 Surface finish 4.1.3 Dimensional tolerantes T
24、he spherical head shall have a diameter equal to the nominal diameter within a tolerante of - 0,2 mm to 0 mm. 4.2 Plastics acetabular components NOTE 2 This subclause refers to plastics acetabular com- ponents for total hip joint replacements in accordance with classification b) of ISO 7206-1. 4.2.1
25、 Sp hericity When measured in accordance with the method giver in A.2, the departure from sphericity shall have a radial Separation value no greater than 100 um. 4.2.2 Surface finish When measured in accordance with the principles given in ISO 468, the spherical articulating surface of the implant s
26、hall have an R, value not greater than 2 um, using a cutoff value of 0,08 mm. The following details should be reported: a) stylus tip radius; b) Position of measurement on specimen. When examined by normal or corrected Vision, the articulating surface shall be free from embedded particles and from s
27、cratches and Score marks other than those arising from the finishing process. 4.2.3 Dimensional tolerantes The spherical socket shall have a diameter equal to the nominal diameter within a tolerante of + 0,l mm When measured in accordance with the principles given in ISO 468, the spherical articulat
28、ing surface of the implant shall have an R, value not greater than 0,5 um, using a cutoff value of 0,08 mm. The following details should be reported: a) stylus tip radius; b) Position of measurement on specimen. When examined by normal or corrected Vision, the articulating surface shall be free from
29、 embedded particles and from scratches a Id Score ma than those arising from the finis iing process. 4.3.3 Dimensional tolerantes The tolerante for the spherical h on the nominal diameter-. ead shall be +0,5 mm 4.4 Bipolar heads rks other NOTE 4 This subclause refers to bipolar heads for fernoral pr
30、ostheses consisting of a concave (inner) spherical surface in a plastics component intended to articulate with a fernoral component of a partial or total hip joint. The bipolar head has also a convex (outer) spherical surface which is intended to articulate with the biological acetabulum. 4.4.1 Inne
31、r articulating surface The inner articulating surface of the plastics part of a bipolar head shall comply with 4.2. 4.4.2 Outer articulating surface The outer articulating surface of a bipolar head shall comply with 4.3. 2 -,-,- ISO 7206-2: 1996(E) Annex A (normative) Determination of radial Separat
32、ion value A.l Fernoral ball Using a three-dimensional measuring machine with a measuring stylus which will allow contact with any Point on the articulating surface to be tested, measure the coordinates of 25 Points P on the articulating surface, 8 spaced equally round the circumference in each of th
33、e planes AA, BB and CC, and 1 Point at the pole (P) (see figure A.l). The pole is the intersection of the axis of the neck with the articulating surface. Planes AA, BB and CC shall be perpendicular to the axis of the neck. If the articulating surface extends to half of the circumfer- ence or to more
34、 than half, AA shall be a diametral plane, otherwise it shall intersect the articulating surface within 1 mm of its border. Angles a, b and c define the positions of the planes AA, BB and CC relative to the neck axis and shall meet the following requirements: c = aJ3 b = 2af3 NOTE 5 If AA is a diame
35、tral plane, a = 90, b = 60” and c = 30”. Determine, using the least squares method, the average diameter D and the coordinates of the centre 0 of the sphere of average diameter. Calculate, for each of the 25 measurement Points P , the radial Separation value R, using the equation: Rs = distance OP -
36、 0,5D The radial Separation value referred to in 4.1 .l shall be the greatest of these calculated values. A.2 Acetabular cup Using a three-dimensional measuring machine with a measuring stylus which will allow contact with any Point on the articulating surface to be tested, measure the coordinates o
37、f 25 Points P of the articulating surface, 8 spaced equally round the circumference in each of the planes AA, BB and CC, and 1 Point at the pole (P) (see figure A.2). Plane AA shall be a diametral plane or, if the articulat- ing surface extends to less than half of a circumfer- ence, it shall inters
38、ect the articulating surface within 1 mm of its border. The pole shall lie on the perpen- dicular drawn from the centre of the plane AA. Angles a, b and c define the positions of the planes AA, BB and CC relative to the axis through the pole and shall meet the following requirements: c = a/3 b = 2a/
39、3 NOTE 6 If AA is a diametral plane, a = 90, b = 60” and c = 30”. Determine, using the least squares method, the average diameter D and the coordinates of the centre 0 of the sphere of average diameter. Calculate, for each of the 25 measurement Points P , the radial Separation value R, using the equ
40、ation: R, = distance OP - 0,5D The radial Separation value referred to in 4.2.1 shall be the greatest of these calculated values. -,-,- ISO 7206-2: 1996(E) ISO Dimensions in millimetres Articulating surfac articulating surface , Figure A.1 - Location of points to be measured on the spherical head Di
41、mensions in millimetres End of articulating surface Figure A.2 - Location of Points to be measured on the acetabulum 4 -,-,- This page intentionally left blank -,-,- This page intentionally left blank This page intentionally left blank ISO 7206-2: 1996(E) ISO ICS 11.040.40 Descriptors: medical equipment, surgical implants, orthopaedic implants, hips, joints (articulation), prosthetic devices, specifications. Price based on 4 pages -,-,-
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