Yes - and there are also FDA (and other) requirements on Hardware and Software traceability used to control drug manufacture - I was trying to give a simple answer to the question in the context of electrical/electronic equipment (61010) that may - or may not - contact the human body.
Best regards Gregg From: [email protected] [mailto:[email protected]]On Behalf Of Ronald R. Wellman Sent: Thursday, February 20, 2003 9:44 AM To: Gregg Kervill; [email protected] Subject: RE: IEC 61010 requirements 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
