Rationalization of standards for medical devices-Part 1.

Current practices for preparing standards in general-and standards for medical devices, instruments, and products in particular-are too slow, too expensive, and too cumbersome. There is a need, therefore, for establishing administrative mechanisms to expedite standards preparation. This paper addresses some administrative, conceptual, and methodological aspects of standards preparation and suggests actions that might contribute to improvements in the effectiveness of standards and in the methods of their preparation.