Laing P G
Department of Orthopaedic Surgery, University of Pittsburgh School of Medicine, PA.
Biomaterials. 1994 May;15(6):403-7. doi: 10.1016/0142-9612(94)90217-8.
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.
在过去四十年里，来自许多国家的外科医生、制造商和科学家之间的合作已达成了最低标准。这些标准适用于外科植入物制造中所使用的材料以及植入物本身的设计和性能。本文介绍了美国和日内瓦国际标准化组织制定标准程序的发展情况。强调了所有工作组对编写现行标准所做的重要贡献。这一过程已在欧洲国家、美利坚合众国、加拿大和其他国家建立起来，以确保在将材料用于制造外科植入物之前对其进行充分研究。此外，植入物本身必须满足经协商一致制定的设计要求，这使得所有利益相关方的意见都能得到表达。本文讲述了标准编写过程中已经发生的情况以及在标准编写过程中仍在继续发生的情况。
