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.
Edition: 1 (Bilingual) ICS: 11.040.01; 35.240.80 Status: Published Stage: 90.92 (2010-07-16) TC/SC: ISO/TC 210 Number of Pages: 151
Revised by: IEC/CD 62304
No corrigenda or amendments available