BS ISO 7206-2-2011 Implants for surgery Partial and total hip joint prostheses Articulating surfaces made of metallic ceramic and plastics materials《外科植入物 部分和全部假体髋关节 金属 陶瓷和塑料材料制成的环.pdf

1、BS ISO 7206-2:2011Implants for surgery Partial and total hip joint prosthesesPart 2: Articulating surfaces made of metallic, ceramic and plastics materialsBS ISO 7206-2:2011+A1:2016BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS ISO 7206-2:2011+A1:2016 BRITISH STA

2、NDARDNational forewordThis British Standard is the UK implementation of ISO 7206-2:2011+A1:2016. It supersedes BS ISO 7206-2:2011, which is withdrawn.The start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indicating changes to ISO text carry the number

3、 of the ISO amendment. For example, text altered by ISO amendment 1 is indicated by .The UK participation in its preparation was entrusted by Technical Committee CH/150/4, Implants for surgery, to Subcommittee CH/150/4, Surgical Implants - Bone and Joint Replacements.A list of organizations represen

4、ted on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2016. Published by BSI Standards Limited 2016ISBN 978 0 580

5、88911 0ICS 11.040.40Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2011.Amendments/corrigenda issued since publicationDate Text affected31 October 2016

6、 Implementation of ISO amendment 1:2016BS ISO 7206-2:2011Reference numberISO 7206-2:2011(E)ISO 2011INTERNATIONAL STANDARD ISO7206-2Third edition2011-04-01Implants for surgery Partial and total hip joint prostheses Part 2: Articulating surfaces made of metallic, ceramic and plastics materials Implant

7、s chirurgicaux Prothses partielles et totales de larticulation de la hanche Partie 2: Surfaces articulaires constitues de matriaux mtalliques, cramiques et plastiques BS ISO 7206-2:2011ISO 7206-2:2011(E) COPYRIGHT PROTECTED DOCUMENT ISO 2011 All rights reserved. Unless otherwise specified, no part o

8、f 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 56 C

9、H-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 2011 All rights reservedBS ISO 7206-2:2011+A1:2016ISO 7206-2:2011+A1:2016(E)BS ISO 7206-2:2011ISO 7206-2:2011(E) ISO 2011 All rights reserved iiiForeword ISO (the Int

10、ernational Organization for Standardization) 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 ha

11、s 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. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical

12、standardization. International Standards 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 bodie

13、s for voting. Publication as an International 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 o

14、r all such patent rights. ISO 7206-2 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 4, Bone and joint replacements. This third edition cancels and replaces the second edition (ISO 7206-2:1996), which has been technically revised. ISO 7206 consists of the follow

15、ing parts, under the general title Implants for surgery Partial and total hip joint prostheses: Part 1: Classification and designation of dimensions Part 2: Articulating surfaces made of metallic, ceramic and plastics materials Part 4: Determination of endurance properties and performance of stemmed

16、 femoral components Part 6: Determination of endurance properties of head and neck region of stemmed femoral components Part 8: Endurance performance of stemmed femoral components with application of torsion Part 10: Determination of resistance to static load of modular femoral heads BS ISO 7206-2:2

17、011+A1:2016ISO 7206-2:2011+A1:2016(E)Text deletedBS ISO 7206-2:2011BS ISO 7206-2:2011+A1:2016BS ISO 7206-2:2011INTERNATIONAL STANDARD ISO 7206-2:2011(E) ISO 2011 All rights reserved 1Implants for surgery Partial and total hip joint prostheses Part 2: Articulating surfaces made of metallic, ceramic a

18、nd plastics materials 1 Scope This part of ISO 7206 specifies 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

19、and ceramic femoral prostheses for partial hip joint 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 femoral components that are in accordance with classification

20、 a) of ISO 7206-1 and with metallic or ceramic outer surfaces which articulate on the biological acetabulum; c) sphericity and surface finish requirements and dimensional tolerances for plastics acetabular components that are in accordance with classification b) of ISO 7206-1; d) sphericity and surf

21、ace finish requirements and dimensional tolerances for metallic or ceramic femoral components of total hip joint prostheses that are in accordance with classification c) of ISO 7206-1, designed to articulate on plastics acetabular components. 2 Normative references The following referenced documents

22、 are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 4287, Geometrical Product Specifications (GPS) Surface texture: Profile method

23、Terms, definitions and surface texture parameters ISO 4288:1996, Geometrical Product Specifications (GPS) Surface texture: Profile method Rules and procedures for the assessment of surface texture ISO 7206-1, Implants for surgery Partial and total hip joint prostheses Part 1: Classification and desi

24、gnation of dimensions BS ISO 7206-2:2011+A1:2016ISO 7206-2:2011+A1:2016(E)BS ISO 7206-2:2011ISO 7206-2:2011(E) 2 ISO 2011 All rights reserved3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 7206-1 and the following apply. 3.1 spherical pole point crea

25、ted by the intersection of the axis of symmetry of the partial sphere of the head or cup with the spherical surface of the head or cup 4 Requirements 4.1 Femoral components of total hip joint prostheses 4.1.1 General This subclause refers to spherical articulating surfaces of femoral components of t

26、otal hip joint prostheses in accordance with classification c) of ISO 7206-1. 4.1.2 Sphericity When measured in accordance with the method given in A.1, the departure from sphericity of the spherical articulating surface of a femoral component shall have a radial separation value not greater than 10

27、 m. 4.1.3 Surface finish When measured in accordance with the principles given in ISO 4287 and performed according to the max.-rule in ISO 4288:1996, 5.3, the spherical articulating surfaces of metallic and ceramic components shall have Ramaxvalues not greater than 0,05 m and 0,02 m respectively and

28、 an Rtmax value not greater than 1,0 m, using a cut-off value of 0,08 mm. The measurements shall be taken at five locations on the spherical surface. One measurement shall be taken in each of four quadrants approximately 30 from the spherical pole and one at the spherical pole. The following details

29、 shall be reported along with the Ramax value: a) stylus tip radius; b) position of measurement on specimen; c) average Ra. When examined by normal or corrected vision, the articulating surface shall be free from embedded particles and from scratches and score marks other than those arising from the

30、 finishing process. 4.1.4 Dimensional tolerances The spherical head shall have a diameter equal to the nominal diameter within a tolerance of 0,2 mm to 0 mm, i.e. it shall be undersized within the given tolerance. 4.2 Plastics acetabular components 4.2.1 General This subclause refers to plastics ace

31、tabular components for total hip joint replacements in accordance with classification b) of ISO 7206-1. BS ISO 7206-2:2011ISO 7206-2:2011(E) 2 ISO 2011 All rights reserved3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 7206-1 and the following apply.

32、 3.1 spherical pole point created by the intersection of the axis of symmetry of the partial sphere of the head or cup with the spherical surface of the head or cup 4 Requirements 4.1 Femoral components of total hip joint prostheses 4.1.1 General This subclause refers to spherical articulating surfa

33、ces of femoral components of total hip joint prostheses in accordance with classification c) of ISO 7206-1. 4.1.2 Sphericity When measured in accordance with the method given in A.1, the departure from sphericity of the spherical articulating surface of a femoral component shall have a radial separa

34、tion value not greater than 10 m. 4.1.3 Surface finish When measured in accordance with the principles given in ISO 4287 and performed according to the max.-rule in ISO 4288:1996, 5.3, the spherical articulating surfaces of metallic and ceramic components shall have Ramaxvalues not greater than 0,05

35、 m and 0,02 m respectively and an Rtmax value not greater than 1,0 m, using a cut-off value of 0,08 mm. The measurements shall be taken at five locations on the spherical surface. One measurement shall be taken in each of four quadrants approximately 30 from the spherical pole and one at the spheric

36、al pole. The following details shall be reported along with the Ramax value: a) stylus tip radius; b) position of measurement on specimen; c) average Ra. When examined by normal or corrected vision, the articulating surface shall be free from embedded particles and from scratches and score marks oth

37、er than those arising from the finishing process. 4.1.4 Dimensional tolerances The spherical head shall have a diameter equal to the nominal diameter within a tolerance of 0,2 mm to 0 mm, i.e. it shall be undersized within the given tolerance. 4.2 Plastics acetabular components 4.2.1 General This su

38、bclause refers to plastics acetabular components for total hip joint replacements in accordance with classification b) of ISO 7206-1. BS ISO 7206-2:2011ISO 7206-2:2011(E) 2 ISO 2011 All rights reserved3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 7

39、206-1 and the following apply. 3.1 spherical pole point created by the intersection of the axis of symmetry of the partial sphere of the head or cup with the spherical surface of the head or cup 4 Requirements 4.1 Femoral components of total hip joint prostheses 4.1.1 General This subclause refers t

40、o spherical articulating surfaces of femoral components of total hip joint prostheses in accordance with classification c) of ISO 7206-1. 4.1.2 Sphericity When measured in accordance with the method given in A.1, the departure from sphericity of the spherical articulating surface of a femoral compon

41、ent shall have a radial separation value not greater than 10 m. 4.1.3 Surface finish When measured in accordance with the principles given in ISO 4287 and performed according to the max.-rule in ISO 4288:1996, 5.3, the spherical articulating surfaces of metallic and ceramic components shall have Ram

42、axvalues not greater than 0,05 m and 0,02 m respectively and an Rtmax value not greater than 1,0 m, using a cut-off value of 0,08 mm. The measurements shall be taken at five locations on the spherical surface. One measurement shall be taken in each of four quadrants approximately 30 from the spheric

43、al pole and one at the spherical pole. The following details shall be reported along with the Ramax value: a) stylus tip radius; b) position of measurement on specimen; c) average Ra. When examined by normal or corrected vision, the articulating surface shall be free from embedded particles and from

44、 scratches and score marks other than those arising from the finishing process. 4.1.4 Dimensional tolerances The spherical head shall have a diameter equal to the nominal diameter within a tolerance of 0,2 mm to 0 mm, i.e. it shall be undersized within the given tolerance. 4.2 Plastics acetabular co

45、mponents 4.2.1 General This subclause refers to plastics acetabular components for total hip joint replacements in accordance with classification b) of ISO 7206-1. BS ISO 7206-2:2011+A1:2016ISO 7206-2:2011+A1:2016(E)This subclause refers to spherical articulating surfaces of femoral components of to

46、tal hip joint prostheses in accordance with classification c) of ISO 7206-1. The principles for the surface finish measurements of hip joint prostheses components are given in ISO 4287. Surface finish measurements shall be performed according to the rules and procedures described in ISO 4288:1996.Th

47、e spherical articulating surfaces of metallic and ceramic components shall have Ramax values not greater than 0,05 m and 0,02 m respectively. ISO 4288:1996, Table 1, requires using a cut-off value of 0,25 mm for the 0,05 m requirement and requires using a cut-off value of 0,08 mm for the 0,02 m requ

48、irement. The Rtmaxvalue shall not be greater than 1,0 m. The cut-off value used to determine the Rt value shall be in accordance with ISO 4288:1996, Table 2.The measurements shall be taken at five locations on the spherical surface. One measurement shall be taken in each of four quadrants approximat

49、ely 30 from the spherical pole and one at the spherical pole. The following details shall be reported along with the Ramax value:a) stylus tip radius;b) position of measurement on specimen;c) average of the five locations measured.When examined by normal or corrected vision, the articulating surface shall be free from embedded particles and from scratches and score marks other than those arising from the finishing process.This subclause refers to plastics acetabular components for to