Standards for Producing Medical Oxygen

God help the patients!

Call 911.

Where is your friend located? Wherever that might be have him/her HIRE A CONSULTANT!

That person can then assume the considerable liability involved in designing a life support system.

You can't do it on the cheap!

If your friend is seriously interested (it is not a small undertaking) the standards, requlations and approvals depend on what country(s) your friend intends to sell to.

Here is a good start.

http://webstore.iec.ch/Webstore/webstore.nsf/mysearchajax?Openform&ICS=11.040

Also your friend will need to look at the local standards authority, government and medical authority websites for specific guidance related to the target market country(s). Also, in addition to the medical standards the equipment will need to pass any applicable electrical and EMC standards and CE, UL (or similar) certification (country dependent).

http://en.wikipedia.org/wiki/CE_mark

http://www.ul.com/global/eng/pages/corporate/standards/

Additionally, a google search of "Medical Oxygen generators" will help give an overview of what is involved (and what standards and approvals existing equipment is tested to for a given country). This should be done first.

http://en.wikipedia.org/wiki/Oxygen_concentrator

This is not a complete list of standards, regulations and certification marks, but as you can see a lot is required to get a product to market in such a specialised field.