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Design Considerations for EMI Gaskets

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI February 1998 Column EMI FIELD NOTES Selecting the proper EMI gasket is a complex task that requires careful examination of all criteria. T he medical device industry clearly understands how...

Choosing Semiconductor Components for Medical Products

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI February 1998 Column INTEGRATED CIRCUITS The selection decision depends on which type of integrated circuit best meets the product's technical and economic requirements. The drive to reduce...

A Guide to AAMI's TIR for EtO-Sterilized Medical Devices

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI February 1998 Column STERILIZATION A step-by-step approach to applying ANSI/AAMI/ISO 10993-7:1995 and AAMI TIR-19 to EtO-sterilized medical devices. While sterilization is a necessary element...

Cooperation Leads to Rapid Development of Global Cleanroom Standards

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI February 1998 Column CLEANROOM STANDARDS ISO TC 209 anticipates completing documents relating to cleanrooms and controlled environments before the year 2000.

Laser Marking Medical Devices and Packaging

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI February 1998 Column LASER MARKING A variety of material-marking problems are addressed by the differing capabilities of three laser systems. The future of medical device manufacturers relies...

A Practical Guide to ISO 10993-14: Materials Characterization

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI February 1998 Column ISO 10993 ISO Working Group 14 is developing a separate standard for materials characterization to lessen the potential for adverse biologic effects caused by materials used...

Health-Care Improvements for the Masses from a Caring Engineer

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI February 1998 Column SNAPSHOT If the number of infectious disease cases drops dramatically in the future because of retractable syringes, Tom Shaw may be among those responsible. Shaw says a...

The FDA Modernization Act: STAYING A NEW COURSE

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI January 1998 Column In addition to improving patient access to needed medical device technologies, the new act may also trigger some changes within the industry. One topic likely to garner...

Australia's Medical Device Industry Is Harmonizing From Down Under

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI January 1998 Column W. S. Vallance, CEO of the Medical Industry Association of Australia, explains the state of the Australian medical device industry and how Australia plans to increase its role...

A Troubled Affair

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI January 1998 Column WASHINGTON WRAP-UP FDA fails to apologize for mishandling Myo-tronics device evaluations. How new is the new FDA? Not new enough for Roland Jankelson, who, despite...

Battery Scientists Seek Smaller, Lighter Cells

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI January 1998 Column R&D HORIZONS Lithium chemistries have altered the industry, but safety is still a concern. The recent boom in personal electronicsparticularly laptops and cell...

To Outsource or Not to Outsource?

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI January 1998 Column BOTTOM LINE As manufacturers face rising costs, shrinking staffs, and increasing time pressures, outsourcing may be the answer to their needs. The buzzword in business...

Biocompatibility Guidelines, Using EtO with Parylene

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI January 1998 Column HELP DESK Richard F. Wallin, PhD, president and CEO of NAMSA (Northwood, OH), explains why complying with biocompatibility guidelines is important when constructing medical...

EMI at the Patient Cable

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI January 1998 Column EMI FIELD NOTES Radio-frequency interference poses a major threat to sensitive patient cables, but there are several ways to address this problem with success.

Two Packaging Standards Give Manufacturers the Ability to Pick and Choose

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI January 1998 Column COVER STORY Having two different packaging standards might appear confusing, but EN868-1 is so narrowly focused that it may be incorporated into ISO 11607, increasing industry...