Ron, Classification of in-vitro devices as medical equipment, requiring regulatory approval, does not influence the choice of product safety standard to be used. If it does not fall within the scope of IEC 60601-1, and is only used in the lab, then IEC 61010 should be used, though IEC 60950 would probably be acceptable if the instrument is based on a PC.
Regards, Jon Griver http://www.601help.com The Medical Device Developers Guide to IEC 60601-1 Hello Greg, I have to disagree with your interpretation. There are many in vitro devices that are classified as medical equipment and are subject to pre-market approvals in the US, Japan, and EU. There are strict regulations on labeling products in the US where even advertising is considered labeling. It's not as simple as contacting a live human, there are many other factors involved based on regulations and interpretations of regulatory authorities. Best regards, Ron Wellman At 11:15 PM 2/19/2003 -0500, Gregg Kervill wrote: >Does it contact a live human - if answer no - it is not medical equipment. > >The purpose for the medical device directive is to protect people for harm >or infection - being alive would seem to be essential for this. > >G > > >------------------------------------------- >This message is from the IEEE EMC Society Product Safety >Technical Committee emc-pstc discussion list. > >Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ > >To cancel your subscription, send mail to: > [email protected] >with the single line: > unsubscribe emc-pstc > >For help, send mail to the list administrators: > Ron Pickard: [email protected] > Dave Heald: [email protected] > >For policy questions, send mail to: > Richard Nute: [email protected] > Jim Bacher: [email protected] > >Archive is being moved, we will announce when it is back on-line. >All emc-pstc postings are archived and searchable on the web at: > http://www.ieeecommunities.org/emc-pstc This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
