The huge change of IEC 60601-1 3rd version is that, in specifying minimum safety requirements, provision is made
for assessing the adequacy of the design PROCESS when this is the only practical method of assessing the safety of certain technologies such as programmable electronic systems.
Application of this principle is one of the factors leading to introduction of a general requirement to carry out a RISK MANAGEMENT PROCESS. In parallel with the development of the third edition of IEC 60601-1, a joint project with ISO/TC 210 resulted in the publication of a general standard for RISK MANAGEMENT of medical devices. Compliance with this edition of IEC 60601-1 requires that the MANUFACTURER have a RISK MANAGEMENT PROCESS complying with ISO 14971 in place.