REPLACEMENT HEART-VALVES AND PERFORMANCE STANDARDS

The international use of medical device standards is expanding for bot h economic and regulatory reasons. It is no longer adequate to have st andards that only specify measurement methods and labeling for a produ ct. An effort needs to be put forth between industry, academia and gov ernment to promote standards that also include a minimum set of accept able performance criteria. This will allow for a less subjective evalu ation of the conformance of the medical device to the appropriate stan dard as well as promote a uniform set of minimal performance expectati ons for a class of products among consumers.