Bit of a rant here... but I'm hoping I've gone wrong somewhere and someone can correct me... So here's the situation (as I see it): Compliance to 60601 is intended to be a voluntary tool to demonstrate safety and effectiveness. Much of the hospital/clinical market in the US follows OSHA regulations, and hence has purchasing policies requiring an NRTL mark on purchased medical devices. In order to mark a medical-device with an NRTL mark, you have to have the device tested to 60601 by an accredited test-lab. CONCLUSION: Testing to 60601 (by an accredited test-lab) is de-facto mandatory for organizations seeking to enter the US clinical market. Please tell me I've misinterpreted the situation.... If this is in fact the case, this is a serious barrier to entry for small organizations for at least a couple of reasons: 1. It requires full compliance testing to not just the base standard (60601-1), but all collaterals as well. 2. It necessitates that all tests be performed by an accredited test-lab (expensive). So, even if the (active) device is simple and safe to begin with - and most safety tests could be easily carried out in-house - a small company must pay tens of thousands for (essentially) the same tests to be carried out by an NRTL? Seems to me an unfortunate situation, that disadvantages small businesses... MM.