|iec 62304 standard pdf||0.05||1||5152||60|
Status of IEC 62304. Approved by both IEC and ISO as an international standard (joint development effort) Adopted by CENELEC as EN and harmonized 11/08 under the MDD, AIMDD and IVDD. Adopted by ANSI as US national standard (replacing ANSI/AAMI/SW 68) Recognized by FDA for use in premarket submissions.What is the iaiec 62304 life cycle?
IEC 62304 defines the life cycle requirements for MEDICAL DEVICE SOFTWARE. The set of PROCESSES,ACTIVITIES, and TASKS described in this standard establishes a common framework for MEDICAL DEVICE SOFTWARE life cycle PROCESSES.What is iaiec 62304 and amd1?
IEC 62304:2006 +AMD1:2015 helps to minimise development overhead by permitting software items to be segregated. In doing so, it requires that “The software ARCHITECTURE should promote segregation of software items that are required for safe operation and should describe the methods used to ensure effective segregation of those SOFTWARE ITEMS”