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BSI - BS EN 80001-1

Application of risk management for IT-networks incorporating medical devices Part 1: Roles, responsibilities and activities

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Organization: BSI
Publication Date: 30 April 2011
Status: active
Page Count: 46
ICS Code (IT applications in health care technology): 35.240.80
ICS Code (Medical equipment in general): 11.040.01

Document History

BS EN IEC 80001-1
November 30, 2021
Application of risk management for IT-networks incorporating medical devices Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
A description is not available for this item.
BS EN 80001-1
April 30, 2011
Application of risk management for IT-networks incorporating medical devices Part 1: Roles, responsibilities and activities
A description is not available for this item.

References

This document references:
IEC 61907 - Communication network dependability engineering
Published by IEC on December 1, 2009
This International Standard gives guidance on dependability engineering of communication networks. It establishes a generic framework for network dependability performance, provides a process for...
This document references:
IEC 62304 - Medical device software – Software life cycle processes
Published by IEC on June 1, 2015
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...
This document references:
BS EN 61907 - Communication network dependability engineering
Published by BSI on July 31, 2010
A description is not available for this item.
This document references:
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...
This document references:
BS EN 15408 - Solid recovered fuels - Methods for the determination of sulphur (S), chlorine (Cl), fluorine (F) and bromine (Br) content
Published by BSI on March 31, 2011
A description is not available for this item.
This document is referenced by:
BS 70000 - Medical physics, clinical engineering and associated scientific services in healthcare – Requirements for quality, safety and competence
Published by BSI on January 31, 2017
A description is not available for this item.
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