FDA to Recognize IEC 60601-1 Third Edition

CDRH is immediately recognizing IEC 60601-1, third edition. The announcement was made yesterday morning at the 20th annual AAMI/FDA international standards conference by Carol Herman, director of the standards management staff at CDRH. The center’s acceptance of the standard also includes “all collaterals and particulars,” said Herman. She anticipates CDRH will publish a Federal Register notice by June 1, and from that point, there will be a three-year transition period. The third edition of IEC 60601-1 deals with the general requirements for basic safety and essential performance of medical electrical equipment. It also includes a Progammable Electrical Medical System (PEMS) clause which replaces the obsoleted 60601-1-4.

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