Most recent

IEC 62304 Ed. 1.0 b:2006

Medical device software - Software life cycle processes


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.


CONTENT PROVIDER
International Electrotechnical Commission [iec]

Others Also Bought
Medical devices - Application of risk management to medical devices
Medical devices - Application of usability engineering to medical devices
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Document History
We have no document history for this standard.