Standards for Joint Replacements

Abstract

There is currently activity in the International Standards Organization in particular with technical committee No. 150, whose remit is to look at surgical implants. One aspect of the work is joint replacement and the secretariat for this exercise is United Kingdom; participating members include West Germany, France, U.S.A., U.S.S.R. and several other countries; many other countries of the world are associated with this in the category of observer members. As other chapters in this book have indicated, selection of materials is particularly important for long-term surgical implants, and one of the early items of work of this committee was specification of the chemical composition, mechanical strength and other characteristics of metals and plastics and ceramics for use in orthopedic implants. Other matters currently under discussion, include marking and packaging of implants by the manufacturers to allow safe delivery, sterile where appropriate, with appropriate information to allow manufacturers to recall products of any batch of material if clinical use demonstrates that a fault may have arisen for any reason. Similarly there are guidelines for safe handling to avoid damage as well as sterilization procedures for those components which may be re sterilized after the package is opened in the operating theatre, or for those components which are supplied in a non-sterile condition.