IS 12375 : Part 2 : 2018/ISO 7206-2 : 2011 Implants for Surgery - Partial and Total Hip Joint Prostheses Part 2 Articulating Surfaces Made of Metallic, Ceramic and Plastics Materials

ICS 11.040.40

MHD 02

NATIONAL FOREWORD

This Indian Standard (Part 2) (First Revision) which is identical with ISO 7206-2 : 2011 ‘Implants for surgery — Partial and total hip joint prostheses — Part 2: Articulating surfaces made of metallic, ceramic and plastics materials’ 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 1993 identical with ISO 7206-2 : 1987. This first revision of this standard has been taken up to align it with the latest version of ISO 7206-2.

The guidance given in this standard on the care and handling of orthopaedic implants after delivery to the purchaser is intended to help ensure that implants remain free from contamination or damage prior to insertion into the patient. Guidance is given on the procedures for receiving, storing, transporting, handling, cleaning, and sterilizing implants. Guidance on procedures for preparing the implants for use, as well as handling during the surgery, are also outlined. This guidance is aimed at all personnel involved in receiving and handling implants, including surgeons. It is important that all personnel be familiar with recommended procedures in order to minimize the risk and occurrence of damage to implants.

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 4 Determination of endurance properties and performance of stemmed femoral components

Part 6 Endurance properties testing and performance requirements of neck region 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.