I would also disagree with Gregg's statement - the 3 Medical Device Directives cover a much wider range of products than he suggests, - just about any device involved in the diagnosis, monitoring, treatment, or alleviation of desease, injury or handicap. This includes many devices that the patient never even sees let alone makes contact with (diagnostic laboratory equipment as an example). This wide range of equipemnt is coverd by a correspondingly wide range of standards, one group of which is the 60601 series for medcial electrcial equipment. The scope of 60601 corresponds roughly to Gregg's definition; it applies to electrical equipment which makes physical or electrical contact with the the patient +/or involves transfer of energy to or from the patient. However the 60601 standards do not encompass all electromedcial devices, let alone all medical devices.
Ged Dean From: Gregg Kervill [mailto:[email protected]] Sent: 20 February 2003 04:15 To: [email protected] Subject: RE: IEC 61010 requirements 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 email and any files transmitted with it are confidential and intended solely for the use of the individual or entity to whom they are addressed. If you have received this email in error please notify the system manager. This footnote also confirms that this email message has been swept by MIMEsweeper for the presence of computer viruses. NCHT ********************************************************************** 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
