Project, generally manager, specific functions

From a regulatory point of view, for this project the general standard EC 60601-1 is applicable, whereas general requirements of 60601-1 may be overwritten or bypassed by specific requirements in the standards for a specific product (EC 60601-2-XX). The analysis of the standards as well as the existing risk management file (as required by EC 14971) and other available documentation delivers the following functions to be considered safety-critical ... 

The standard is generic , i.e. it provides a generalized approach to the management and design of functional safety systems that can be applicable to any type of industry. It is intended for direct use in any project but it is also intended to be the basis for industry sector standards. Hence, more specific industry sector standards will be expected to follow with alignment of their principles to the master standard . 

---