Codes & Standards - Purchase
IEC 62304:2006
Medical device software - Software life cycle processes
SKU: iec_006792_036055
Published by IEC
Publication Year 2006
1.0 Edition
155 pages
Product Details
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.