This is a newly released standard as of 19 June 2014. Are you ready to use this standard for your emergency medical services equipment (i.e. equipment used in and around ambulances and at locations where emergency medical services would be needed like a crash site. The breadth of medical electrical equipment that this will cover is a wide swath and so manufacturers should start thinking about designing their products for these more rugged requirements. Some of the testing is similar to the Home Use Environment Standard (IEC 60601-1-11) as that was a base for some of the development of this standard (IEC 60601-1-12). The scope of the standards is for Medical Electrical Equipment (MEE) & Medical Electrical Systems (MES) which are intended, as indicated by the IFU by their manufacturer, for use in the Emergency Medical Services (EMS) Environment.
The definition of EMS Environment per the standard is:
- actual conditions and settings, in which OPERATORS interact with the ME EQUIPMENT or ME SYSTEM, in and around the scene of an emergency outside of a professional healthcare facility where a PATIENT can be given medical care, basic or advanced life support as well as during professional transport to a professional healthcare facility or between professional healthcare facilities