Biomedical Products, International Standards for

Donald E. Marlowe

Donald E. Marlowe

U.S. Food and Drug Administration, Office of Science and Health Coordination, Rockville, Maryland

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First published: 14 April 2006

Abstract

International standards for biomedical products have become the coin-of-the-realm in the discussions among governments, product manufacturers, and users. These stakeholders use these documents to allow a supplier and user of goods or services to describe to each other what is being supplied and to ensure or improve public safety and health. What are international standards? This article will discuss the topic at several levels and identify the sources of these standard for biomedical products.

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