BS ISO 7206-2-2011 en_5169 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接表面》.pdf

1、BS ISO 7206-2:2011 Implants for surgery Partial and total hip joint prostheses Part 2: Articulating surfaces made of metallic, ceramic and plastics materials BS ISO 7206-2:2011+A1:2016 BSI Standards Publication WB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS ISO 7206-2:2011+A1:2016 BRITIS

2、H STANDARD National foreword This 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 It supersedes BS ISO 7206-2:2011, which is withdrawn.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 th

3、e number 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 organization

4、s represented 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 2016 ISB

5、N 978 0 580 88911 0 ICS 11.040.40 Compliance 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 publication Date Text affect

6、ed 31 October 2016 Implementation of ISO amendment 1:2016BS ISO 7206-2:2011Reference number ISO 7206-2:2011(E) ISO 2011INTERNATIONAL STANDARD ISO 7206-2 Third edition 2011-04-01 Implants for surgery Partial and total hip joint prostheses Part 2: Articulating surfaces made of metallic, ceramic and pl

7、astics materials Implants chirurgicaux Prothses partielles et totales de larticulation de la hanche Partie 2: Surfaces articulaires constitues de matriaux mtalliques, cramiques et plastiques BS ISO 7206-2:2011 ISO 7206-2:2011(E) COPYRIGHT PROTECTED DOCUMENT ISO 2011 All rights reserved. Unless other

8、wise 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 either ISO at the address below or ISOs member body in the country of the requester. ISO copyright

9、 office Case postale 56 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 2011 All rights reservedBS ISO 7206-2:2011+A1:2016 ISO 7206-2:2011+A1:2016(E)BS ISO 7206-2:2011 ISO 7206-2:2011(E) ISO 2011 All rights reserv

10、ed iiiForeword ISO (the International 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 whi

11、ch a technical committee has 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 m

12、atters of electrotechnical 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 cir

13、culated 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 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 respon

14、sible for identifying any or 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

15、7206 consists of the following 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

16、 and performance of stemmed 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 fe

17、moral heads BS ISO 7206-2:2011+A1:2016 ISO 7206-2:2011+A1:2016(E) Text deleted BS ISO 7206-2:2011 BS ISO 7206-2:2011+A1:2016BS ISO 7206-2:2011 INTERNATIONAL STANDARD ISO 7206-2:2011(E) ISO 2011 All rights reserved 1Implants for surgery Partial and total hip joint prostheses Part 2: Articulating surf

18、aces made of metallic, ceramic and 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 f

19、inish requirements for metallic 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 i

20、n accordance with classification 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 IS

21、O 7206-1; d) sphericity and surface 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 Th

22、e 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 referenced document (including any amendments) applies. ISO 4287, Geometrical Product Specifications (GPS)

23、Surface texture: Profile method 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

24、 Part 1: Classification and designation of dimensions BS ISO 7206-2:2011+A1:2016 ISO 7206-2:2011+A1:2016(E)BS ISO 7206-2:2011 ISO 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 ap

25、ply. 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 s

26、urfaces 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 se

27、paration 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

28、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 spherical pole and one at the sph

29、erical 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

30、 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 components 4.2.1 General Thi

31、s 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 ISO 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

32、ISO 7206-1 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 ref

33、ers to 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 c

34、omponent 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 hav

35、e Ramaxvalues 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 sp

36、herical 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

37、 from 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 acetabul

38、ar components 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 ISO 7206-2:2011(E) 2 ISO 2011 All rights reserved3 Terms and definitions For the purposes of this document, the

39、terms and definitions given in ISO 7206-1 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

40、.1.1 General This subclause refers to 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 arti

41、culating surface of a femoral component 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 a

42、nd ceramic components shall have Ramaxvalues 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 quadran

43、ts approximately 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 Ra. When examined by normal or corrected vision, the articulating surface shall be f

44、ree from embedded particles and from 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 t

45、olerance. 4.2 Plastics acetabular components 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 ISO 7206-2:2011(E) 2 ISO 2011 All rights reserved3 Terms and definitions For the

46、purposes of this document, the terms and definitions given in ISO 7206-1 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

47、of total hip joint prostheses 4.1.1 General This subclause refers to 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 s

48、phericity of the spherical articulating surface of a femoral component 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 arti

49、culating surfaces of metallic and ceramic components shall have Ramaxvalues 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 spherical pole and one at the spherical pole. The following details shall be reported along with the Ramax value: a) stylus tip rad