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New Edition of IEC 62353 Published

Medical Devices | In Compliance Magazine

The International Electrotechnical Commission has published a new edition of IEC 62353. IEC 62353 applies to “Medical electrical equipment – Recurrent test and test after repair of medical electrical equipment.” The new edition is available on the IEC website.

Description*

IEC 62353:2014 applies to testing of medical electrical equipment and medical electrical systems, hereafter referred to as ME equipment and ME systems, or parts of such equipment or systems, which comply with IEC 60601-1:1988 (second edition) and its amendments and IEC 60601-1:2005 (third edition) and its amendments, before putting into service, during maintenance, inspection, servicing and after repair or on occasion of recurrent tests to assess the safety of such ME equipment or ME systems or parts thereof.”

*Description from IEC website

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