Essential Standards for Biomedical Engineering

Being a regulated industry, the Biomedical Engineering industry has a number of essential standards to help in your work. There are a plethora of international standards out there that can be of assistance, but here are some that are absolutely essential.

Any electronic medical device must be designed to comply with the safety requirements in IEC 60601: “Medical Electrical Equipment”.

There is an excellent ISO standard applicable to Medical Device Software engineering, ISO 62304: “Medical device software -- Software life cycle processes”. It is based on the older ANSI/AAMI standard SW68:2001 and is indispensable reading for anyone involved in medical device software development. There is a really great technical report written by the committee that wrote this standard that all engineers working in this field should read, namely AAMI TIR32: “Medical Device Software Risk Management”. It's the Da Vinci Code of medical device software. I highly recommend it. And because ISO 62304 is based on ISO 12207, it works really well in a system engineering environment based on ISO 15288.

Here are how these standards relate to each other:

Note that each of the ISO standards in the diagram are accompanied by related Technical Reports, which are also essential reading. There isn't yet a specific System Engineering standard for medical devices, but the relevant sections of ISO 15288 can still be applied appropriately.

---

Social Bookmark this page: