Re: Question about new edition of IEC 60601-1
This is, i think THE main problem with using the new series of IEC 60601 standards: how to use standards requirements in conjunction with a risk management framework.
Well, trying not to complicate too much: the requirements of safety standards are risk controls options for manufacturers. So, in in the first place you would have to identify hazardous situations (in my present view, i would derive the hazardous situation from a requirement on a requirements management process or from a further hazard identification process ), estimate risk, define that the risk of the hazardous situation is unnaceptable using your risk acceptability criteria, and then you would need to apply a risk control option. This is where the standard requirement would come in. You have a lot of technical options to control the risk, but the safety standard requirement is the easiest because someone has already though about it. Then you would have to implement the control, and verify the implementation and effectiveness of the control measure. If you did not use the safety standard requirement, you would have to create a "test" to verify both. As you has used the easiest way, things just happen to be a little more easier, because, besides giving a risk control measure option (the requirement itself) the standard also give you the way to verify the implementation and effectiveness (the test method). Only problem is, some test methods parameters can vary, because of different environmental conditions for example...so, you only need to define the right parameters to verify the implementation and effectiveness of your risk control measure option.
All this information, surely, will need to be in your product risk management file.
