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August 2002
Medical Device & Diagnostic Industry
Selected Contents


EDITOR'S PAGE

Caution: Military-Industrial Complex Ahead


COVER STORY

Double-Redundant and Fail-Safe Design for Packaging Machinery
Ray Johnson

When properly applied, double-redundant and fail-safe design methods focus validation practices on machine enhancement and reliability, reducing dependence on operator vigilance and intervention.


COATING TECHNOLOGY

Assessing the Effects of Sterilization Methods on Parylene Coatings
Lonny Wolgemuth

Results of laboratory tests provide insight to the poststerilization characteristics of this common device-coating material.

Sidebar: Parylene Coating Technology


ELECTRONICS

Understanding the New EMC Standard for Medical Devices: What Manufacturers Need to Know Now
Don Sherratt

Meeting the new requirements set forth in the latest edition of 60601-1-2 might prove challenging for OEMs.

 


WASHINGTON WRAP-UP

FDA's Feigal Raps Industry on Quality

James G. Dickinson

CDRH director also discusses budget woes, user fees at AdvaMed forum.


R&D DIGEST:


BULLETIN BOARD

Polyamide-imide material performs well in nonlubricated applications. Protein-based biomaterials offer an unusually high level of human compatibility. A company offers a wide variety of nitinol fabrication operations, and more!



NEWS & ANALYSIS