Any changes to a standard can create concern within a company on the effects it will have on their products. The concern is even greater for medical device manufacturers that must show compliance to the new standard once the regulatory bodies set a date.
In this session, we will discuss the changes that are expected with Amendment 2, of the IEC 60601-1 standard, to allow you to start thinking about how this will affect your products. We will cover the high level changes occurring to the standard. With any amendment to the base standard, it will have other effects. We will additionally discuss the other effect the amendment will have to the 60601 series of standards.
Healthcare Principal Engineer