BS ISO 7207-2-2011 Implants for surgery Components for partial and total knee joint prostheses Articulating surfaces made of metal ceramic and plastics materials《外科植入物 部分和全部膝关节修复术用.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS ISO 7207-2:2011Implants for surgery Components for partial andtotal knee joint prosthesesPart 2: Articulating surfaces made of metal,ceramic and plastics materialsBS ISO 7207-

2、2:2011 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 7207-2:2011. Itsupersedes BS7251-14:1998 which is withdrawn.The UK participation in its preparation was entrusted toTechnical Committee CH/150/4, Surgical Implants - Bone and JointReplacements.A list of org

3、anizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 66597 4ICS 11.040.40Compliance with a British Standard

4、cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 July 2011.Amendments issued since publicationDate Text affectedBS ISO 7207-2:2011Reference numberISO 7207-2:2011(E)ISO 2011INTERNATIONAL STANDARD I

5、SO7207-2Second edition2011-07-01Implants for surgery Components for partial and total knee joint prostheses Part 2: Articulating surfaces made of metal, ceramic and plastics materials Implants chirurgicaux lments de prothses partielle et totale de larticulation du genou Partie 2: Surfaces articulair

6、es constitues de matriaux mtalliques, cramiques et plastiques BS ISO 7207-2:2011ISO 7207-2:2011(E) COPYRIGHT PROTECTED DOCUMENT ISO 2011 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 mechanical, i

7、ncluding 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 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Pub

8、lished in Switzerland ii ISO 2011 All rights reservedBS ISO 7207-2:2011ISO 7207-2:2011(E) ISO 2011 All rights reserved iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International

9、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 liaison with ISO, al

10、so 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 of technical committ

11、ees 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 is drawn to the poss

12、ibility 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 7207-2 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 4, Bone and joint replacements. Th

13、is second edition cancels and replaces the first edition (ISO 7207-2:1998), which has been technically revised. ISO 7207 consists of the following parts, under the general title Implants for surgery Components for partial and total knee joint prostheses: Part 1: Classification, definitions and desig

14、nation of dimensions Part 2: Articulating surfaces made of metal, ceramic and plastics materials BS ISO 7207-2:2011BS ISO 7207-2:2011INTERNATIONAL STANDARD ISO 7207-2:2011(E) ISO 2011 All rights reserved 1Implants for surgery Components for partial and total knee joint prostheses Part 2: Articulatin

15、g surfaces made of metal, ceramic and plastics materials 1 Scope This part of ISO 7207 specifies surface finish requirements for the articulating surfaces of total and partial knee joint prostheses classified in ISO 7207-1. This part of ISO 7207 is intended to provide guidance for periodic validatio

16、n of production processes. 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 referenced document (including any amendments) applies.

17、 ISO 4287, Geometrical Product Specifications (GPS) 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 3 Surface finish re

18、quirements 3.1 General All surface finish measurements shall be performed according to the max.-rule in ISO 4288:1996, 5.3. The max.-rule states that no measurement values shall exceed the specified Ramax. 3.2 Knee joint prostheses 3.2.1 Metallic or ceramic femoral components When measured in accord

19、ance with ISO 4287, all articulating surfaces of a metallic or ceramic femoral component shall be measured across the full articulating surface at locations in an approximately square grid of locations no more than 10 mm apart. The component shall have an Ramax value 0,1 m, using a cut-off value of

20、0,08 mm. NOTE The patellar flange is considered an articulating surface in bicompartmental, tricompartmental and patellar femoral replacement systems. BS ISO 7207-2:2011ISO 7207-2:2011(E) 2 ISO 2011 All rights reservedThe following details should be reported along with the surface roughness, Ra, val

21、ues: a) stylus tip radius; b) position of measurements on the specimen. When examined with normal or corrected vision, the articulating surface shall be free from embedded particles, defects and raised edges and from scratches and score marks. 3.2.2 Metallic or ceramic tibial articulating components

22、 of a mobile bearing knee When measured in accordance with ISO 4287, all articulating surfaces of a metallic or ceramic tibial component shall be measured across the full articulating surface at locations in an approximately square grid of locations no more than 10 mm apart. The component shall have

23、 an Ramax value 0,1 m, using a cut-off value of 0,08 mm. The following details should be reported along with the surface roughness, Ra, values: a) stylus tip radius; b) position of the measurements on the specimen. When examined with normal or corrected vision, the articulating surface shall be free

24、 from embedded particles, defects and raised edges and from scratches and score marks. 3.2.3 Plastics tibial and patella components When measured in accordance with ISO 4287, all articulating surfaces of a tibial and patella component shall be measured across the full articulating surface at locatio

25、ns in an approximately square grid of locations no more than 10 mm apart. The component shall have an Ramax value 2 m, using a cut-off value of 0,08 mm. The following details should be reported along with the measured surface roughness, Ra, values: a) stylus tip radius; b) position of the measuremen

26、ts on the specimen. When examined with normal or corrected vision, the articulating surface shall be free from embedded particles, defects and raised edges and from scratches and score marks other than those arising from the finishing process. BS ISO 7207-2:2011ISO 7207-2:2011(E) ISO 2011 All rights

27、 reserved 3Bibliography 1 ISO 7207-1, Implants for surgery Components for partial and total knee joint prostheses Part 1: Classification, definitions and designation of dimensions BS ISO 7207-2:2011ISO 7207-2:2011(E) ICS 11.040.40 Price based on 3 pages ISO 2011 All rights reserved This page deliber

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