More government participation in standards could help prevent two different agencies from adopting different and conflicting standards, AAMI says.
An example of a lack of consensus surrounds IEC 60601-1, the electrical equipment standard. Last year, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health recognized the third and latest edition of the standard.
The Occupational Safety and Health Administration uses the previous edition of 60601-1 for a different purpose than FDA, and is “now indicating it will not recognize the third edition,” AAMI says. “This presents some serious difficulties for industry.”
Read the AAMI news release urging more government involvement.
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