Guidance Documents

The sub-pages to this page contain guidance documents related to the IEC/ISO 60601 & 80601 series of safety standards, and their related process standards for Risk Management, Usability Engineering, and Software development. The guidance consists of mostly documents stored on our Google Drive, but in some cases are web pages. The sub-pages with a Google Doc, display the Google Doc in a frame. You can view the document in the frame panel, or as the document may be fairly long, you can use the link icon in upper right hand corner of the frame to view the document in new tab. From there you can view, or you can download as pdf, Word doc, or print.

Any and all comments and feedback are welcome. Please use our Contact Us page.


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.

Sortable Index

This lists all guidance documents. You can use the link icon in upper right hand corner to view in new tab. From there you can sort any field to help idenfiy guidance of interest to you. You sort by using the down arrow icon in the header column. Clicking the Title Link will bring you to a new tab with guidance document.