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FDA Announces Intent to Recognize 3rd Edition |
AAMI (Association for the Advancement of Medical
Instrumentation) released an announcement which reports the FDA (U.S. Food and Drug Administration) will formally recognize the electrical
equipment standard IEC 60601-1/Ed.3:2006. "We will not only recognize the third edition of the standard, but we will also
recognize all collaterals and all particulars," Herman told attendees. Read Complete Announcement..
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| IEC-60601 for Medical-Grade Power Supplies |
New standards are being proposed that will change the medical-device approval process, turning the current method upside down. These new standards will change the method of approving medical equipment from simple parameter testing to an involved collaboration of risk declaration and the methods applied to identify and minimize those risks. Read More...
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| Medically Approved Power Supply Considerations |
 The term "medical-grade" is applied to power supplies in a variety of package styles and, at a glance, these supplies may look no different than their commercial-grade counterparts. However, medical equipment typically requires longer design cycles than other types of equipment and medical equipment designers often require more design support from the power supply vendor.
When selecting a medical-grade power supply consider the following criteria as they relate to your application requirements. Read More... |
UL 60601 Medical Safety Testing & Certification
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| UL 60601-1 is the U.S. national standard for safety testing electrical medical devices. Learn more about global requirements, CB Scheme, and the 3rd Edition of IEC 60601 which is in the process of being adopted by countries and public health organizations globally. Read More... |
Now that the market is showing signs of recovery, projects that were once on hold are now starting to regain momentum. Medical Standards play an important role when specifying power supplies. We have included a few articles that we hope will help when specifying medical power supplies.
