Earlier this month the EU published a new notice of standards harmonised under the three medical devices directives. Although this in itself is news, I would like to put the spotlight on one interesting standard that will give manufacturers of medical devices that are early adopters in eHealth and medical technology in the home a strategic advantage: the EN 60601-1-11:2010 Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. In the words of the IEC:
“IEC 60601-1-11:2010 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems which are intended by their manufacturer for use in the home healthcare environment, regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The object of IEC 60601-1-11:2010 is to specify general requirements that are in addition to those of the general standard IEC 60601-1:2005 and to serve as the basis for particular standards.”
This standard takes all kinds of home situation related risks and dependencies into account, such as inexpert users, less-than-optimal clinical environment, less-than-clinical standard electricity supply and so on. A nice overview is provided in this white paper on home healthcare equipment by Underwriters Laboratories. By referring to compliance with this standard, authorities in the EU have to assume compliance of manufacturers of medical devices with the essential safety requirements for medical devices, so this standard will clarify what is required for home use devices.
As eHealth develops, more and more medical technology will be moved into the home for detecting and measuring purposes. eHealth providers seem very much focused on the standards for devices and applications involved in eHealth to talk to each other, but the devices that are the senses of the eHealth applications will be functioning in home situations. These devices will often qualify as medical devices in their own right, or, if they function together with certain applications or services that constitute medical devices, as accessories to those medical devices (and therefore need regulatory clearance as medical devices in their own right). In those cases EN 60601-1-11:2010 will be an important standard.
The standard is of course not only important for eHealth applications, but also for devices already functioning in the home.