DS/EN 62304
Medical device software - Software life-cycle processes
active, Most Current
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| Organization: | DS |
| Publication Date: | 5 November 2015 |
| Status: | active |
| Page Count: | 48 |
| ICS Code (IT applications in health care technology): | 35.240.80 |
| ICS Code (Medical equipment in general): | 11.040.01 |
scope:
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.
Document History
DS/EN 62304
November 5, 2015
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...
October 24, 2013
Medical device software - Software life-cycle processes
This standard 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...
September 12, 2006
Medical device software - Software life-cycle processes
This standard 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...
Medical device software - Software life-cycle processes
This standard 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...