World standards for surgical implants: an American perspective.

Working cooperation among surgeons, manufacturers and scientists, working in many countries, over the last forty years has arrived at minimal standards. These standards are for both the materials to be used in the manufacture of surgical implants and for the design and performance of the implants themselves. An account is given here of the development of the standards writing procedure in the United States and the International Standards Organization in Geneva. The important contributions of all the working groups to write the present standards is underline. This process has been set up within the European countries, the United States of America, Canada and other nations, to make sure that materials are adequately investigated prior to their use for the manufacture of surgical implants. In addition the implants themselves must satisfy design requirements which have been set up by consensus, this allows for the expression of all interests. This is an account of what has been going on in standards writing and continues to take place in the writing of standards.