Paolo, Whether you are planning to market this product in Europe under the CE mark, or in North America, you need to be aware of IEC 60601-1 and ISO 14871.
IEC 60601-1 is the primary electrical safety standard for electrical medical devices and requires that a risk assessment be done under ISO 14871. This will include requirements for control reliability where failure of the software is a contributor to patient injury. You will need to be able to carry out a software V & V (Validation and Verification) process on the software to ensure that you will not have unexpected behaviour due to software errors. A good standard for this is AAMI SW68. This standard lays out the requirements for software V & V in medical devices and should be on the top of your hit parade. As Brian pointed out in his post, this is not something to be undertaken lightly. If your company does not have a corporate structure that will support the level of effort required, you are best advised to choose an alternative. You do not have control of the OTS software. The manufacturer could introduce changes to the code that might result in unexpected failure modes and they have no obligation to inform you of the changes. It's possible, but difficult to use OTS software this way - consider your options carefully! -- Doug Nix, A.Sc.T. IEEE PSES Waterloo Region Canada [email protected] > From: Paolo Peruzzi <[email protected]> > Date: Fri, 10 Nov 2006 17:47:25 +0100 > To: [email protected], " <[email protected]>"@elenmail.com (E-mail) > Subject: software certification > > Dear Group, > > My company is designing a new medical system and for the first time we would > like to use an off-the-shelf software as Operating system, and maybe develop > some applications running under it. > > I have heard that for the system CE certification, the third part > software could be an issue. It seems that using a "non-certified" software, > (like Linux, instead of Microsoft for example) could get us into trouble. > > Has anybody experience on this matter? > > Do we have to proceed as we would have developed the whole software (thus > providing all the needed documentation on sw development, specifications, > risk analysis, verifications and validation)? There is some shortest way or > what? > > Thanks in advance, > > Paolo Peruzzi > > Regulatory Medical R&D > El.En. S.p.A. > Via Baldanzese, 17 > 50041 Calenzano (FI) > Italy > > Tel. +39 055 8826807 > FAX +39 055 8832884 > http://www.elengroup.com/ > > - > ---------------------------------------------------------------- > This message is from the IEEE Product Safety Engineering Society > emc-pstc discussion list. Website: http://www.ieee-pses.org/ > > To post a message to the list, send your e-mail to [email protected] > > Instructions: http://listserv.ieee.org/request/user-guide.html > > List rules: http://www.ieee-pses.org/listrules.html > > For help, send mail to the list administrators: > > Scott Douglas [email protected] > Mike Cantwell [email protected] > > For policy questions, send mail to: > > Jim Bacher: [email protected] > David Heald: [email protected] > > All emc-pstc postings are archived and searchable on the web at: > > http://www.ieeecommunities.org/emc-pstc - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to [email protected] Instructions: http://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas [email protected] Mike Cantwell [email protected] For policy questions, send mail to: Jim Bacher: [email protected] David Heald: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc ______________________________________________________________________ This email has been scanned by the MessageLabs Email Security System. For more information please visit http://www.messagelabs.com/email ______________________________________________________________________
