Iec 60601 1 third edition amendment 1 ed 31 what you need to know for manufacturers of medical electrical equipment and systems iec 60601 1 edition 31 or iec 60601 12005 amd12012 represents a significant departure from edition 30 of the standard. Discussion about the 3rd edition to include a overview of significant differences as compared to previous editions b review of risk management and the manufacturers responsibility c mandated . Iec 60601 1 changes from 2nd to 3rd edition wwwintertek etlsemkocom 3 of our clients are continuing to use the 2nd edition. Does your company have approval for iec 60601 1 if you produce medical electrical equipment mee or systems you soon will have to as this general standard applies to all devices
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