ISO 7206-4:2010/Amd 1:2016

Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components - Amendment 1

Implants chirurgicaux — Prothèses partielles et totales de l'articulation de la hanche — Partie 4: Détermination des propriétés d'endurance et des performances des tiges fémorales — Amendement 1

General Information

• Status: Published
• Publication Date: 20-Mar-2016
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 150/SC 4 - Bone and joint replacements
• Drafting Committee: ISO/TC 150/SC 4 - Bone and joint replacements
• Current Stage: 6060 - International Standard published
• Start Date: 21-Mar-2016
• Due Date: 05-Jun-2017
• Completion Date: 05-Jun-2017

Relations

• Amends: ISO 7206-4:2010 - Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components
• Effective Date: 07-Aug-2021

Overview

ISO 7206-4:2010/Amd 1:2016 is an internationally recognized amendment to the ISO 7206-4:2010 standard focused on implants for surgery, specifically partial and total hip joint prostheses. This part of the ISO 7206 series addresses the determination of endurance properties and performance of stemmed femoral components used in hip joint replacements. By establishing rigorous testing methods and performance criteria, this standard ensures that hip prostheses exhibit the necessary durability and reliability for long-term clinical use.

Maintained by ISO Technical Committee ISO/TC 150, Subcommittee SC 4 (Bone and joint replacements), this amendment incorporates critical updates, including revised figures and test specimen orientation guidelines, aiding manufacturers and testing laboratories in achieving compliance with the latest best practices in hip implant evaluation.

Key Topics

• Endurance Properties Testing
  The standard specifies testing procedures to evaluate the fatigue strength and durability of stemmed femoral components under physiological loading conditions. These tests simulate long-term mechanical stresses experienced in vivo.

• Performance Assessment of Stemmed Femoral Components
  Detailed methods are provided for analyzing structural integrity and mechanical behavior of hip prosthesis stems, designed to prevent premature failure and improve patient safety.

• Specimen Orientation for Testing
  Amendment 1 introduces updated guidelines on specimen alignment, including the critical angles and load axes relative to stem orientation, as illustrated in the revised Figure A.6. Correct positioning optimizes the accuracy of endurance testing.

• Dimensional References and Load Points
  The standard defines key measurement points including head offset, stem axis, neck axis, load point, and cement level, which are crucial for consistent testing and result interpretation.

• Harmonization with ISO Directives
  Developed in alignment with ISO/IEC Directives Part 1 and Part 2, the amendment follows strict editorial and procedural rules to maintain international consistency and reliability.

Applications

ISO 7206-4:2010/Amd 1:2016 serves as a vital guideline for multiple stakeholders within the orthopedic implant industry:

• Medical Device Manufacturers
  Ensuring that stemmed femoral components of hip prostheses meet endurance requirements reduces risk of implant failure and increases clinical success rates. Manufacturers use this standard to develop and validate their prosthesis designs.

• Testing Laboratories
  Adopting this standard enables laboratories to perform standardized fatigue and performance tests, generating reliable data that supports regulatory submissions and product certifications.

• Regulatory Authorities
  National and international health authorities refer to ISO 7206-4 to assess compliance of hip joint prostheses, facilitating consistent approval and monitoring processes for implantable devices.

• Orthopedic Surgeons and Hospitals
  Although primarily technical, the outcomes supported by this standard indirectly benefit surgical decision-making by confirming the mechanical reliability of implants used in hip replacement procedures.

Related Standards

To fully ensure the quality and safety of hip joint prostheses, ISO 7206-4:2010/Amd 1:2016 should be considered alongside other related ISO standards in the implants for surgery series:

• ISO 7206-1 - Specifications and test methods for partial and total hip joint prostheses, focusing on overall design and performance parameters.

• ISO 7206-2 - Determination of bending strength of stemmed femoral components.

• ISO 7206-6 - Methods for determining fatigue properties of head and neck regions of hip prostheses.

• ISO 10993 Series - Biological evaluation of medical devices, covering biocompatibility testing crucial for implant safety.

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Keywords: ISO 7206-4 amendment, hip joint prostheses, stemmed femoral components, endurance testing, orthopedic implants, hip replacement standards, implant durability, medical device testing, surgical implants ISO standards, fatigue properties hip prostheses

Standards Content (Sample)

DRAFT AMENDMENT
ISO 7206-4:2010/DAM 1
ISO/TC 150/SC 4 Secretariat: BSI
Voting begins on: Voting terminates on:
2015-09-15 2015-12-15
Implants for surgery — Partial and total hip joint
prostheses —
Part 4:
Determination of endurance properties and performance
of stemmed femoral components
AMENDMENT 1
Implants chirurgicaux — Prothèses partielles et totales de l’articulation de la hanche —
Partie 4: Détermination des propriétés d’endurance et des performances des tiges fémorales
AMENDEMENT 1
ICS: 11.040.40
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO 7206-4:2010/DAM 1:2015(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2015

ISO 7206-4:2010/DAM 1:2015(E) ISO 7206-4:2010/DAM 1

Contents Page
Foreword .iv
1 Replace figure A.6 with the figure below .1
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2015 – All rights reserved
----------
...

INTERNATIONAL ISO
STANDARD 7206-4
Third edition
2010-06-15
AMENDMENT 1
2016-03-15
Implants for surgery — Partial and
total hip joint prostheses —
Part 4:
Determination of endurance
properties and performance of
stemmed femoral components
AMENDMENT 1
Implants chirurgicaux — Prothèses partielles et totales de
l’articulation de la hanche —
Partie 4: Détermination des propriétés d’endurance et des
performances des tiges fémorales
AMENDEMENT 1
Reference number
ISO 7206-4:2010/Amd.1:2016(E)
©
ISO 2016
ISO 7206-4:2010/Amd.1:2016(E)
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2016 – All rights reserved

ISO 7206-4:2010/Amd.1:2016(E)
Foreword
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 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, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This d
...