BS ISO 7207-2-2011 en_2329 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.pdf

1、raising standards worldwide NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BSI Standards Publication BS ISO 7207-2:2011 Implants for surgery Components for partial and total knee joint prostheses Part 2: Articulating surfaces made of metal, ceramic and plastics materialsBS IS

2、O 7207-2:2011 BRITISH STANDARD National foreword This British Standard is the UK implementation of ISO 7207-2:2011. It supersedes BS7251-14:1998 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/150/4, Surgical Implants - Bone and Joint Replacements.

3、 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 necessary provisions of a contract. Users are responsible for its correct application. BSI 2011 ISBN 978 0 580 66597 4 ICS 11.040.40 Compliance wit

4、h 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 31 July 2011. Amendments issued since publication Date Text affectedBS ISO 7207-2:2011Reference number ISO 7207-2:2011(E) ISO

5、2011INTERNATIONAL STANDARD ISO 7207-2 Second edition 2011-07-01 Implants 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 gen

6、ou Partie 2: Surfaces articulaires constitues de matriaux mtalliques, cramiques et plastiques BS ISO 7207-2:2011 ISO 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 m

7、eans, 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 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail cop

8、yrightiso.org Web www.iso.org Published in Switzerland ii ISO 2011 All rights reservedBS ISO 7207-2:2011 ISO 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). Th

9、e 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 has been established has the right to be represented on that committee. International organizations, governmental and non-gov

10、ernmental, 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. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

11、The main task 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 vo

12、te. 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 or all such patent rights. ISO 7207-2 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC

13、4, Bone and joint replacements. This 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: Cla

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

15、oint prostheses Part 2: Articulating 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 prov

16、ide guidance for periodic validation 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

17、(including any amendments) applies. 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

18、surface texture 3 Surface finish requirements 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

19、 components When measured in accordance 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 val

20、ue 0,1 m, using a cut-off value of 0,08 mm. NOTE The patellar flange is considered an articulating surface in bicompartmental, tricompartmental and patellar femoral replacement systems. BS ISO 7207-2:2011 ISO 7207-2:2011(E) 2 ISO 2011 All rights reservedThe following details should be reported along

21、 with the surface roughness, Ra, values: 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 ce

22、ramic tibial articulating components 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 1

23、0 mm apart. The component shall have 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, th

24、e articulating surface shall be free 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

25、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 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 r

26、adius; b) position of the 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 other than those arising from the finishing process. BS ISO 7207-2:2011 I

27、SO 7207-2:2011(E) ISO 2011 All rights 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 7207-2:2011 ISO 7207-2:2011(E) ICS 11.040.40 Price based on 3 pages ISO 2011

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