IS 12375 : Part 6 : 2018/ISO 7206-6 : 2013 Implants for Surgery - Partial and Total Hip Joint Prostheses Part 6 Endurance Properties Testing and Performance Requirements of Neck Region of Stemmed Femoral Components

ICS 11.040.40

MHD 02

Reaffirmed 2023

NATIONAL FOREWORD

This Indian Standard (Part 6) (First Revision) which is identical with ISO 7206-6 : 2013 ‘Implants for surgery — Partial and total hip joint prostheses — Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Orthopaedic Instruments, Implant and Accessories Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

This standard was first published in 1998 identical with ISO 7206-6 : 1992. This first revision of this standard has been taken up to align it with the latest version of ISO 7206-6.

The test method described in this standard is intended for the verification of the endurance properties of the neck region of stemmed femoral components of hip joint prostheses. This method is based extensively on that given in Part 4 of this standard, which verifies the endurance properties of the complete femoral component under loading conditions that include a torsional component. The test conditions in Part 4 of this standard, especially the height of the specimen embedding, are intended to represent the clinical situation where the prosthesis has become loosened in the femur, whereas the test conditions in this standard are intended to represent a correctly and firmly fixed prosthesis. Therefore, it should be noted that the tests in this standard may not be representative of the most unfavourable clinical conditions.

This standard has been published in various parts under the general title ‘Implants for surgery — Partial and total hip joint prostheses’. The other parts are as under:

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 femoral components

The text of ISO Standard has been approved as suitable for publication as an Indian Standard without deviations. Certain conventions are however not identical to those used in Indian Standards. Attention is particularly drawn to the following:

a) Wherever the words ‘International Standard’ appear referring to this standard, they should be read as ‘Indian Standard’.

b) Comma (,) has been used as a decimal marker while in Indian Standard, the current practice is to use a point (.) as the decimal marker.