The international standard IEC — medical device software — software life cycle processes  is a standard which specifies life cycle requirements for the development of medical software and software within medical devices. It is harmonized by the European Union EU  and the United States US ,  and therefore can be used as a benchmark to comply with regulatory requirements from both these markets. The standard spells out a risk-based decision model on when the use of SOUP is acceptable, and defines testing requirements for SOUP to support a rationale on why such software should be used. From Wikipedia, the free encyclopedia.
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Some rush fees may apply. Add to Cart. View Full Details and Buy. Complementary Documents and Links:. These are referenced. This standard emphasises the need for the complete and precise specification of the safety functions, based on the analysis of design basis accidents and consideration of the main plant safety goals. The implementation of these requirements leads to various types of defence against initiating CCF events.
Means to achieve protection against CCF are discussed in this standard in relation to: a susceptibility to internal plant hazards and external hazards; b propagation of physical effects in the hardware e. Browse Publishers. Top Sellers. My Account. Corporate Sustainability. Investor Relations. All Rights Reserved. Update Cart. Create New Account.