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BSI - BS EN 62304

Medical device software - Software life-cycle processes

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Organization: BSI
Publication Date: 30 November 2006
Status: active
Page Count: 88
ICS Code (IT applications in health care technology): 35.240.80
ICS Code (Software): 35.080
ICS Code (Medical equipment in general): 11.040.01

Document History

19/30390556 DC
January 24, 2019
Draft BS EN 62304 Health software - Software life cycle processes
A description is not available for this item.
18/30344861 DC
March 14, 2018
Draft BS EN 62304 Health software - Software life cycle processes.
A description is not available for this item.
BS EN 62304
November 30, 2006
Medical device software - Software life-cycle processes
A description is not available for this item.
BS EN 62304
November 30, 2006
Medical device software Software life-cycle processes
Purpose 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...
BS EN 62304
November 30, 2006
Medical device software - Software life-cycle processes
A description is not available for this item.

References

This document references:
BS EN 61010-1 - Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1: General requirements
Published by BSI on November 30, 2010
A description is not available for this item.
This document references:
ISO/IEC 33004 - Information technology - Process assessment - Requirements for process reference, process assessment and maturity models
Published by ISO on March 1, 2015
This International Standard sets out the requirements for process reference models, process assessment models, and maturity models. The requirements defined in this International Standard form a...
This document is referenced by:
BS EN 794-3 - Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
Published by BSI on January 15, 1999
A description is not available for this item.
This document is referenced by:
IEEE 11073-10419 - Health informatics — Personal health device communication — Part 10419: Device specialization — Insulin pump
Published by IEEE on March 1, 2019
This standard establishes a normative definition of communication between personal telehealth insulin pump devices (agents) and managers (e.g., cell phones, personal computers, personal health...
This document is referenced by:
BS EN 62083 - Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
Published by BSI on March 31, 2010
A description is not available for this item.
This document is referenced by:
BS EN 60601-1 - Medical Electrical Equipment Part 1: General Requirements for Safety
Published by BSI on September 29, 1989
This Standard applies to the safety of MEDICAL ELECTRICAL EQUIPMENT (as defined in Sub-clause 2.2.15). Although this Standard is primarily concerned with safety, it contains some requirements...
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