In the previous post Meditech: Powering the unit michaelkellett rose the problem of electrical safety and general medical devices compliance about the possible risks adopting some components, especially related to the power supply architecture.
It is clear that as Meditech will be a medical device patient safety from any possible device derived injuries should be considered in depth. The actual phase of the project, that is the definition of the parts and the general architecture, consider with more attention the bare technical aspects than the specific medical safety compliance. This aspect will be reviewed later, probably the better choice is on the first full-working prototype. There are anyway some aspects that I have always in mind.
Powering system
It is almost obvious that this will be the most critical aspect related to potential shock damage to the patient. In the power architecture design I have already took some precautions, like setting the charging unit removable and available only in some conditions while the device is not working with the health probes.
The prototype design anyway is highly modular and the powering system can be independently redesigned despite the rest of electronics.
Medical safety standards for electronic design
This aspect can't be covered by a single general application as the regulatory instructions will vary by country. The approach is that a generally "safe" prototype should be open to be localised following the specifications in every country.
A good source about the medical electronic devices esign can be found in the article of Jerry Tower, in Electronic Design blog. The article can also be found in attach to this post.