What is the difference between EN 60601 and IEC 60601?

The IEC 60601 standard is a comprehensive set of medical electrical equipment safety requirements designed to protect patients, operators, and caregivers from potential electric shock, fire hazards, and other risks. IEC 60601-1 testing is a certification that proves the device meets all IEC 60601 safety requirements. EN 60601 is an adaptation of IEC 60601 for use in European countries. While the two standards are similar in concept, there are some differences in details between IEC and EN versions of the standard.

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