Even standards are extremely boring for reading, in medical design is must, agree with Ruben. I'm not familiar with mechanical standards for medical industry, but I read many of the electrical/electronics and software standards for medical equipment. Those standards are quite expensive (unless you are able to find some draft versions on the web). Try to be more specific about what are you searching for and perhaps you'll find some good books or links to download them. Vasile http://www.itim-cj.ro/~vasile/ On Tue, Nov 24, 2015 at 10:28 AM, wrote: > If you are going to make medical grade electronics I really think that > you > do need knowledge (perhaps not exhaustive though) about the regulatory > procedures and standards. Why not get that from the horse's mouth - The > standards. You should have read the applicable standards so that you, > at > least, have some feel for what is different from standard industrial or > residential/commercial electronics. I have not done this myself but you > may need to implement safety measures by redundancy, not use a part > above a certain percent of its rated power/voltage/current values > and/or > use increased creepage and clearance to mention some. > > This way you won't have to guess and risk doing things all over again > when it comes back from regulatory compliance testing. > > I also think that you must follow some quality assurance protocol, both > for production and design and development. For design and development > it means that you need to do risk assessment and work with a well > documented requirement specification which also states the applicable > standards, and you can't do that without having (access to) the > standards. > > /Ruben > > On Mon, 23 Nov 2015 23:24:35 -0800, Jesse Lackey > wrote: > > Hi all, after 10 years of freelance (!), I have taken a full-time "real > > job"! I'm now the main EE guy at this company that makes pneumatically > > driven cutters for eye surgery. Most of what they do is more mechanica= l > > than electrical, but they have a few (aging, created a number of years > > ago) custom electronic designs. I'm updating those and moving forward > > on a number of fronts in the near term. > > > > I'm looking for a good book for electonic design in the medical > > industry. I don't think I'll need some exhaustive discussion of > > regulatory procedure (doing the official compliance documentation will > > be someone else or another company), but more along the lines of > > numerous good tips/guidelines/gotchas. > > > > Over the last 10 years, my EE skills evolved from basic to senior, in n= o > > small part to the help and discussion on PICList, and I want to thank > > you all for contributing your time and knowledge to the greater good of > > all. Personally I'm thrilled to have my future efforts go towards the > > never ending goal of better medical processes and tools to more people > > around the world - and you PICListers have helped make that possible. > > > > Cheers all! > > J > > -- > http://www.piclist.com/techref/piclist PIC/SX FAQ & list archive > View/change your membership options at > http://mailman.mit.edu/mailman/listinfo/piclist > --=20 http://www.piclist.com/techref/piclist PIC/SX FAQ & list archive View/change your membership options at http://mailman.mit.edu/mailman/listinfo/piclist .