IEC 62340 PDF

The international standard IEC — medical device software — software life cycle processes [1] 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 [2] and the United States US , [3] 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. International Electrotechnical Commission. Retrieved 2 June

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Nuclear power plants — Instrumentation and control systems important to safety — Requirements for coping with common cause failure CCF. Detail Summary View all details.

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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.

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