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
You can purchase IEC 60601-1-12 currently on the IEC website and in the near future I would expect it to be on the standards websites like TechStreet, IHS Global, the Document Center, etc.  Also, I would assume that in the near future AAMI will also be publishing this standard at a minimum as IEC 60601-1-12 but I am hoping also as an AAMI standard but I need to check into this and I will report back as I can’t find it as a US based standards project on the AMMI standards website.
 
If you need additional support for IEC 60601-1-12 or IEC 60601-1-11 (the home use environment) standards please email Leo Eisner at , or call Leo at +1-(503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants). We are here to help you thru this process.   

 

IEC 60601-1-12 Just Published – MEE & MES Intended for Use in Emergency Medical Services Environment