Evolving Standards Reshape Medical Power Supplies

Apr 1, 2007 12:00 PM
By Peter Resca, Director of Engineering, and Dave Murray, Senior Product Engineer, Astrodyne, Mansfi

Meeting New Challenges

The environment for electrical designers in the medical arena is challenging. Understanding, interpreting and applying the wide variety of global standards for the product requires extensive knowledge of the standards. This knowledge must include general requirements, collateral standards, type specifications and an understanding of the regulatory differences between individual countries, which can disrupt the development and marketing process. This is a difficult challenge and now designers must begin to understand the new requirements being proposed.

These new challenges require design engineers, system engineers and manufacturers to be aware of the changes. It also requires significant changes to the certification of medical power supplies. The product compliance test, which starts at the product, is now inverted to start with compliant processes. To comply with the proposed standards, managers would have to institute risk-management processes from which compliant products could be spawned.

The timing of the transition to the new standards has not been set. In fact, most industry experts believe we are still one to three years away from the third edition becoming required for medical devices including power supplies. Despite the new standards not being required today, power-supply manufacturers and system integrators should pay careful attention to the changes in anticipation of modifying current practices for future compliance.

References

1. Elliott, Steve, “Power Supplies in Medical Electronics,” EPN Web editorial, www.epn-online.com, December 2003.

2. Beecroft, John, “Designing Considerations for Medical Power Supplies,” EPN Web editorial, www.epn-online.com, April 2005.

3. Resca, Peter, “Practical Considerations for Medical Power Supply Design,” Power Electronics Technology Conference, 2006.

4. Schmidt, Mike W., “IEC 60601-1, 2005: A Revolutionary Standard, Part 1,” Medical Device & Diagnostic Industry, February 2005.

5. “Medical Electrical Equipment — Part 1: General Requirements for Safety,” IEC 60601-1 Second Edition, International Electrotechnical Commission, 1988.

6. Rudolph, Harvey, and Sidebottom, Charles, “The Role of Risk Management in the New IEC 60601-1”, Medical Device & Diagnostic Industry, January 2006.

7. Henderson, Steven, “A First Look at IEC 60601-1 3rd Edition,” Conformity, August 2006, pages 20-29.

8. Eisner, Leo, O'Brien, Frank, Schmidt, Mike W., and Modi, Dan, “A New U.S. National Standard for Medical Devices,” Medical Device & Diagnostic Industry, September 2006.

Keeping the Acronyms Straight

Organizations that provide medical-device approval standards.

• Canadian Standards Association (CSA), www.csa.ca
• Underwriters Laboratories (UL), www.ul.com
• International Organization for Standards (ISO), www.iso.org
• International Electrotechnical Commission (IEC), www.iec.ch
• American National Standards Institute (ANSI), www.ansi.org
• ASTM International Standards Worldwide, www.astm.org
• Association for the Advancement of Medical Instrumentation (AAMI), www.aami.org

Want to use this article? Click here for options!
© 2007 Penton Media, Inc.