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US FDA recognises AAMI medical electrical equipment standard

This article was originally published in RAJ Devices

Executive Summary

The US Food and Drug Administration is now accepting declarations of conformity to the third edition of the international standard on medical electrical equipment, IEC 60601-1/Ed.3:2006, in support of pre-market submissions1-3. The agency's recognition of the third edition is seen as a significant shift, as the standard focuses more on risk management than pure testing.




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