Hello all, There is some confusion between medical devices, in vitro diagnostic devices, and the scopes of possibly applicable safety standards.
In the US in vitro diagnostic devices are a type of medical device and all medical devices are subject to applicable FDA regulation. In Europe, there are separate Directives for medical devices and in vitro diagnostic devices. Both IEC EN 60601-1 series and IEC EN 61010 series are appropriate safety standards for electrically powered medical devices. However, the scopes of the two documents are different. 60601 applies to the safety of MEDICAL ELECTRICAL EQUIPMENT (a defined term). MEDICAL ELECTRICAL EQUIPMENT is defined as: electrical EQUIPMENT, provided with not more than one connection to a particular SUPPLY MAINS; and intended to diagnose, treat, or monitor the PATIENT under medical supervision; and which makes physical or electrical contact with the PATIENT and/or transfers energy to or from the PATIENT and/or detects such energy transfer to or from the PATIENT the EQUIPMENT includes those ACCESSORIES as defined by the manufacturer which are necessary to enable the NORMAL USE of the EQUIPMENT Hence, only that electrical equipment that connects to the patient or controls the flow of energy into or out of the patient is in scope of 60601-1. Any other electrical equipment, intended for medical use in a hospital, is likely to be in scope of either IEC EN 61010 series or might even be medical software running on (ITE) IEC EN 60950 hardware. Both directives and the FDA have extensive quality systems (design and manufacturing), postmarket surveilance, and device specific premarket requirements. Any organization that is not familiar with these requirements should seek professional help before starting to even design products for these marketplaces. Best regards, Dave Osborn Philips Medical Systems 3000 Minuteman Road Andover, MA 01810-1099 +1 978 659 3178 fax +1 978 685 5624 [email protected] 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
