IEC 62304 –
medical device
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
software –
software life cycle processes is an
international standard
An international standard is a technical standard developed by one or more international standards organizations. International standards are available for consideration and use worldwide. The most prominent such organization is the International O ...
published by the
International Electrotechnical Commission
The International Electrotechnical Commission (IEC; ) is an international standards organization that prepares and publishes international standards for all electrical, electronics, electronic and related technologies. IEC standards cover a va ...
(IEC). The standard specifies life cycle requirements for the development of
medical software and software within medical devices. It has been adopted as national standards and therefore can be used as a
benchmark to
comply with regulatory requirements.
Implications of IEC 62304 for software
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.
Contents
Source:
General requirements
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Quality management system
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Risk management
Risk management is the identification, evaluation, and prioritization of risks, followed by the minimization, monitoring, and control of the impact or probability of those risks occurring. Risks can come from various sources (i.e, Threat (sec ...
*
Software safety classification
Software development process
* 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
Software maintenance process
* Establish software maintenance plan
* Problem and modification analysis
* Modification implementation
Software risk management process
* 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
* Configuration identification
* Change control
* Configuration status accounting
Software problem resolution process
* 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
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International Electrotechnical Commission
The International Electrotechnical Commission (IEC; ) is an international standards organization that prepares and publishes international standards for all electrical, electronics, electronic and related technologies. IEC standards cover a va ...
(IEC)
*
List of IEC standards
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IEC 60601 - safety and essential performance of medical electrical equipment
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ISO 14971
ISO 14971 ''Medical devices — Application of risk management to medical devices'' is a voluntary consensus standard, published by International Organization for Standardization (ISO) for the first time in 1998, and specifies terminology, principl ...
— application of risk management to medical devices
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ISO 13485 — medical devices, quality management systems: requirements for regulatory purposes
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ISO 9001 — quality management systems: requirements
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International Standards for automating the software structural quality
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Therac-25 a computer-controlled radiation therapy machine which was one prompt for IEC 62304
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Time-triggered system (a software architecture that is used in many safety-critical systems)
References
External links
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#62304
Regulation of medical devices
Software development process
Medical software
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