IEC 62304
Encyclopedia
The international standard
IEC 62304 - medical device
software
– software life cycle processes 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 and the United States, and therefore can be used as a benchmark to comply with regulatory requirements from both these markets.
International standard
International standards are standards developed by international standards organizations. International standards are available for consideration and use, worldwide...
IEC 62304 - medical device
Medical device
A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...
software
Medical software
In computers, medical software is a significant branch of software engineering. Many medical devices that monitor or control patients are predominantly controlled by software. Medical devices are frequently regulated and must comply with local and regional laws. In the European Union, these...
– software life cycle processes is a standard which specifies life cycle
SDLC
SDLC can refer to:* Systems Development Life Cycle, known also as "System Design Life Cycle"* "Software Development Life Cycle" synonym to Software development process* Synchronous Data Link Control, an IBM Protocol...
requirements for the development of medical software
Medical software
In computers, medical software is a significant branch of software engineering. Many medical devices that monitor or control patients are predominantly controlled by software. Medical devices are frequently regulated and must comply with local and regional laws. In the European Union, these...
and software within medical devices. It is harmonized by the European Union and the United States, and therefore can be used as a benchmark to comply with regulatory requirements from both these markets.
See also
- International Electrotechnical CommissionInternational Electrotechnical CommissionThe International Electrotechnical Commission is a non-profit, non-governmental international standards organization that prepares and publishes International Standards for all electrical, electronic and related technologies – collectively known as "electrotechnology"...
(IEC) - List of IEC standards
- IEC 60601-1
- ISO 14971ISO 14971ISO 14971 is an ISO standard, of which the latest revision was published in 2007, that represents the requirements for a risk management system for medical devices....