Iec 60601 1 ed 31 label manual checklist rev 4 2015 04 28 edition 31 requirements for the labeling and the accompanying documents ifu of medical electrical equipment it also includes information and interpretations for the clause requirements as applicable. In iec 60601 1 labeling is deemed a critical component of a medical device and the standard provides comprehensive requirements for marking and labeling skip to main content sign in join toggle navigation iec 60601 1 medical device marking and labeling. Medical safety iec 60601 1 3rd edition the iec 60601 1 standard is a globally recognized standard for electro medical equipment safety and a parent standard over 60 particular device standards. This problem arose during an audit to 60601 1 3rd edition when i asked someone knowledgeable about fda regulations she told me that the revision level of the label was required to be on the label per regulation im trying to track down that regulation this requirement is not in the 60601 1 3rd edition standards section for label requirements
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