The international standardIEC 62304 – 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.
Match traffic based on URL category for policy enforcement. Crack url filter ip.
Jungle de ikou deviantart. IEC 62301 Household electrical appliances – Measurement of standby power IEC 62304 Medical Device Software – Software Life Cycle Processes IEC 62305 Protection Against Lightning. The IECEE is the International Commission on the Rules for the Approval of Electrical Equipment being a standardization body of the International Electrotechnical Commission. The IEC uses the name IECEE for the IEC System for Conformity Testing and Certification of Electrotechnical Equipment and Components, known as the CB Scheme. INTERNATIONAL IEC STANDARD 62304 First edition 2006-05 Medical device software – Software life cycle processes This English-language version is derived from the original bilingual publication by leaving out all French-language pages. Missing page numbers correspond to the French-language pages. Reference number IEC (E). IEC 62301 Standby Power and IEC61000-3-2 Current Harmonics Testing 29 Dec 2015 Duration: 51:06. This webinar explores The International Electrotechnical Commission (IEC) 62301 and the 61000-3-2 compliance test procedures for measuring standby power and current harmonics respectively.
Andrew David Morton (born 1953) is one of the world's best-known biographers and a leading authority on modern celebrity. His groundbreaking biography Diana: Her True Story was a #1 New York Times bestseller, as was Monica's Story, an authorized biography of Monica Lewinsky, and Tom Cruise: An Unauthorized Biography. Mar 16, 2018 About Author Andrew David Morton: The writer of “Diana: Her True Story” is an English writer. Andrew David Morton is a very good journalist and a very good biography writer as well. The book we are talking about is the best book of his life. Features of Diana: Her True Story PDF: English is the original language of the book. Andrew morton princess diana pdf.
- 2Contents[5]
Cricut Design Space Software Download
Implications of IEC 62304 for software[edit]
The IEC 62304 standard calls out certain cautions on using software, particularly SOUP (software of unknown pedigree 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.[4]
Contents[5][edit]
General requirements[edit]
Software development process[edit]
- Software development planning
- Software requirements analysis
- Software architectural design
- Software detailed design
- Software unit implementation and verification
- Software integration and integration testing
- Software system testing
- Software release
Effect of safety classification on required development process documentation[6][edit]
Software documentation | Class A | Class B | Class C |
---|---|---|---|
Software development planning | X | X | X |
Software requirements analysis | X | X | X |
Software architectural design | X | X | |
Software detailed design | X | ||
Software unit implementation | X | X | X |
Software unit verification | X | X | |
Software integration and integration testing | X | X | |
Software system testing | X | X | |
Software release | X | X | X |
X - required |
Software maintenance process[edit]
- Establish software maintenance plan
- Problem and modification analysis
- Modification implementation
Software risk management process[edit]
- Analysis of software contributing to hazardous situations
- Risk control measures
- Verification of risk control measures
- Risk management of software changes
- Security and reliability through software quality
Software configuration management process[edit]
- Configuration identification
- Change control
- Configuration status accounting
Software problem resolution process[edit]
- Prepare problem reports
- Investigate the problem
- Advise relevant parties
- Use change control process
- Maintain records
- Analyse problems for trends
- Verify software problem resolution
- Test documentation contents
See also[edit]
- International Electrotechnical Commission (IEC)
- Time-triggered system (a software architecture that is used in many safety-critical systems)
References[edit]
- ^International Electrotechnical Commission (2006). 'Medical device software – Software life cycle processes'(PDF). INTERNATIONAL IEC STANDARD 62304 First edition 2006-05. International Electrotechnical Commission. Retrieved 2 June 2012.
- ^'Medical devices - European standards - Enterprise and Industry'. 2012-11-04. Retrieved 2018-07-26.
- ^Staff (20 August 2012). 'Recognized Consensus Standards'. FDA US Food and Drug Administration. US Department of Health & Human Services. Retrieved 26 January 2015.
- ^Hall, Ken (June 1, 2010). 'Developing Medical Device Software to IEC 62304'. EMDT - European Medical Device Technology. Retrieved 2012-12-11.
- ^'IEC 62304:2006(en) Medical device software — Software life cycle processes'. ISO. 2006. Retrieved 15 June 2017.
- ^'Developing Medical Device Software to IEC 62304 | MDDI Medical Device and Diagnostic Industry News Products and Suppliers'. www.mddionline.com. Retrieved 2017-06-15.
External links[edit]
- 'IEC 62304' at International Electrotechnical Commission
Retrieved from 'https://en.wikipedia.org/w/index.php?title=IEC_62304&oldid=889807267'