This blog is part 2 of my Electrical Engineer’s overview of one of the more important standards for medical devices: IEC 60601-1.
Posts by Bjarne Hansen
Sorting through the alphabet soup of the many standards that apply during medical device development can be daunting. This blog gives an overview of one of the more important ones: IEC 60601-1. The first installment covers Scope and Normative References. Part 2 covers detailed descriptions of the sixteen sections.
I love working with ultrasound. Diagnostic imaging devices are what most people think of when ultrasound is mentioned, but it is also widely used for analyzing body fluids, treating kidney stones, enhancing drug delivery, and managing pain. My StarFish clients have innovative as well as traditional applications for ultrasound. Those projects involve general 2D […]
Things I Learned about Medical Device Design Consulting at the Boatyard My partner and I have sailed long passages between islands in the Pacific in the past and plan to do so again. Spending weeks, even months, in locations far from machine shops, lumberyards and hospitals, it is important to be self-sufficient. Thus, any opportunity to […]
Medical devices containing electronics require Electromagnetic Compatibility (EMC) testing to ensure they can be used in the intended environment without causing other equipment to fail nor failing themselves. Here are some simple and inexpensive tools an electrical engineer can build that enable quick EMC prescreening. This article includes steps one can take during product development to […]
Hacking (gaining access to a device through unintended means) commonly has negative connotations, but it need not imply an intent to destroy data or harm hardware. I’ll use the term Hacking in this blog, with the acknowledgement that when malicious intent is involved, a better term is Cracking. Hacking medical devices is not new, but […]
We all need trust. Trust that the sun will shine tomorrow (OK – not necessarily in Victoria in February); trust that gravity will keep our feet firmly on the floor. We also tend to trust what we read, believing that what someone has spent time to put to words is likely reliable. There are, however, […]
Like Wile E. Coyote’s persistent attempts at catching the Roadrunner, sometimes it takes multiple attempts to get a product through EMC testing. Why? And what can we do to increase the likelihood of passing on the first or second iteration? Electromagnetic Interference (EMI) is unwanted effects in a medical device due to electromagnetic energy present […]
Communication errors occur in many situations. We may miss hearing a spouse’s request to “buy milk” over the crying of an infant. A phone ringing during your presentation may cause you to stutter. Or a medicine expected to expire on 07-08-12 actually expires on 12-07-08. Here are some reasons for misheard communications: Ambient interference and […]
Microprocessors are ubiquitous. Today’s toothbrushes and razors come with microprocessors built in. See for example, Schick’s Hydro Razor and “Inside the Schick Hydro Microcontroller Powered Wet Razor“. This popularity has been fueled by the perception that “intelligent” products are better and enabled by rapidly declining costs for microprocessors. A microprocessor is a general-purpose computer contained on […]