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The sub-pages to this page contain guidance related to the IEC/ISO 60601 & 80601 series of safety standards, and their related process standards for Risk Management, Usability Engineering, and Software development.


This information is for guidance purposes only and should not be regarded as a substitute for your own responsibilities for creating a safe design, which might include seeking professional safety consulting advice. We no longer provide professional safety consulting services.

Guidance can become inaccurate or incomplete as it becomes out-dated. Each guidance document includes the the date it was last revised. Standards get updated. It's your responsibility to use the latest version of the standard required by the regulators in the markets in which you intend to sell, or otherwise identified by your design control and risk management process.