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MedTech Mindset Blog

Does IEC 60601 govern your device? Don’t be shocked if it does.

By Daniel Henrich on Jan 14, 2019 8:17:27 AM


Bad puns aside, it’s good you’ve come to this post if you’re involved in developing or commercializing a new medical device, especially if that device has a battery or a plug. 

In the world of medical device development, there are a number of international standards that apply. ISO standards 13485 and 14971, for example, spell out requirements for quality management systems and risk management processes, respectively. Though these documents can seem long, boring, and repetitive, they contain procedures to which a device company must adhere, beginning in the design phase and continuing throughout the product lifecycle.

A lesser-known, but still critically important, standard is IEC 60601 Medical Electrical Equipment. 60601 was developed to ensure the basic safety and essential performance of electrical equipment that comes into contact with patients during treatment or diagnosis.

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