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Third edition of IEC 60601 recognized by FDA

This article was originally published in The Silver Sheet

Executive Summary

FDA will immediately begin recognizing the third edition of the International Electrotechnical Commission's (IEC) family of standards for medical electrical equipment safety and performance. The third edition of IEC 60601 represents a major overhaul of the existing standard, namely by requiring medical electrical equipment manufacturers to have formal risk-management processes in place. The third edition was published in 2005, but FDA reviewers needed time to adjust to the new risk-management piece, FDA's standards management director Carol Herman explained at a March 9 session of the AAMI/FDA International Conference on Medical Device Standards and Regulation in Reston, Va. Firms will have three years to switch over to the new standard. A Federal Register notice on the topic is expected soon, Herman said
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