| 词条 | Software of unknown pedigree |
| 释义 |
Often, engineering projects are faced with economic or other pressure to embody SOUP into their high integrity systems.{{Citation needed|date=April 2009}} The problem with SOUP is that it cannot be relied upon to perform safety-related functions, and it may prevent other software, hardware or firmware from performing their safety-related functions. The SOUP problem is therefore one of insulating the safety-involved parts of a system from the SOUP and its undesirable effects.[2] SOUP is now a defined term ("Software Of Unknown Provenance") in some medical device regulations through the standard IEC 62304:2006 "medical device software –software life cycle processes". It is not prohibited to use SOUP but additional controls are needed and the risk needs to be taken into account. Specific practices to take when using SOUP as part of a medical device may include review of the vendor's software development process, use of static program analysis by the vendor, design artifacts, and safety guidance.[3] References1. ^{{cite conference|author=Felix Redmill|booktitle=Proceedings of the 20th International Conference on Computer Safety, Reliability and Security, SAFECOMP 2001, Budapest, Hungary, September 26–28, 2001|editor=Udo Voges|pages=122|title=The COTS Debate in Perspective|publisher=Springer|date=2001|isbn=978-3-540-42607-3}} 2. ^{{cite journal |url=http://www.emdt.co.uk/article/developing-medical-device-software-iso-62304 |title=Developing Medical Device Software to IEC 62304 |last=Hall |first=Ken |work=EMDT - European Medical Device Technology |date=June 1, 2010 |accessdate=2012-12-11}} 3. ^{{cite journal |url=https://web.archive.org/web/20130123140527/http://medicaldesign.com/engineering-prototyping/software/device-cots-soup-1111/ |title=Device makers can take COTS, but only with clear SOUP |last=Hobbs |first=Chris |work=Medical Design |date=2011-11-01}} Further reading
1 : Safety engineering |
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