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or provenance). 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.
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and software within medical devices. It has been adopted as national standards and therefore can be used as a
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The IEC 62304 standard calls out certain cautions on using software, particularly SOUP (
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Effect of safety classification on required development process documentation
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Standards for automating the software structural quality
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Analysis of software contributing to hazardous situations
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INTERNATIONAL IEC STANDARD 62304 First edition 2006-05
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442:. International Electrotechnical Commission
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202:Software unit implementation
108:Software architectural design
102:Software development planning
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1463:. You can help Knowledge by
327:Configuration identification
281:Software maintenance process
97:Software development process
60:software of unknown pedigree
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364:Test documentation contents
358:Analyse problems for trends
292:Modification implementation
216:Software unit verification
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81:Quality management system
242:Software system testing
111:Software detailed design
349:Advise relevant parties
346:Investigate the problem
343:Prepare problem reports
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120:Software system testing
32:international standard
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381:List of IEC standards
305:Risk control measures
75:General requirements
28:software life cycle
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541:"IEC 62304"
519:. June 2010
26:software –
1504:Categories
523:2024-01-17
472:2024-01-17
418:References
396:ISO 13485
391:ISO 14971
386:IEC 60601
44:benchmark
20:IEC 62304
1457:software
401:ISO 9001
369:See also
144:Class C
141:Class B
138:Class A
71:Source:
67:Contents
1422:Related
1135:13522-5
923:ISO/IEC
814:62014-4
727:61131-9
722:61131-3
692:60906-1
685:60870-6
680:60870-5
497:15 June
493:. 2006
446:2 June
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Text is available under the Creative Commons Attribution-ShareAlike License. Additional terms may apply.