Bureau of Medical Devices Standards Survey, 1982. International Edition

摘要

The purpose of the BMD Standards Survey is to provide a comprehensive listing of current national and international standards promulgation activities in the field of medical devices. These standards include voluntary, regulatory, proposed, tentative, and recommended standards; recommended practices; purchasing specifications; policy statements; and glossaries of technical terms. Since the standards identify criteria such as safety and performance, the Survey serves as a basis for the continuing review of the adequacy of existing standards and as a guideline for the development of new standards. This Survey is published in two parts: the International Edition in January and the National Edition in July. For this reason standards developed in the United States are not listed in the International Edition although American standards developing organizations are active in the international sphere. Standards listed in the Survey are not available from the FDA; they must be obtained from the association, society or publisher which authorized the documents (listed in Section C). Many international standards can be purchased from the American National Standards Institute, Inc., 1430 Broadway, New York, N.Y. 10018.