Publication detail
| Reference | IEC 62304 ed1.0 |
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| Title | Versión Oficial En español - Software de dispositivos médicos. Procesos del ciclo de vida del software | |||||||||
| Publication date | 2006-05-09 | |||||||||
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| Abstract | Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes. Applies to the development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device. This standard does not cover validation and final release of the medical device, even when the medical device consists entirely of software. | |||||||||
| Technical Committee | 62A - Common aspects of electrical equipment used in medical practice
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| Stability date | 2012 | |||||||||
| Work in progress |
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