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BSI - BS PD ISO/TS 20405

Health informatics — Framework of event data and reporting definitions for the safety of health software

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Organization: BSI
Publication Date: 31 May 2018
Status: active
Page Count: 26
ICS Code (IT applications in health care technology): 35.240.80

Document History

BS PD ISO/TS 20405
May 31, 2018
Health informatics — Framework of event data and reporting definitions for the safety of health software
A description is not available for this item.

References

This document references:
IEC 80001-1 - Application of risk management for IT-networks incorporating medical devices – Part 1: Roles, responsibilities and activities
Published by IEC on October 1, 2010
Recognizing that MEDICAL DEVICES are incorporated into IT-NETWORKS to achieve desirable benefits (for example, INTEROPERABILITY), this international standard defines the roles, responsibilities and...
This document references:
IEC 80001-1 - Application of risk management for IT-networks incorporating medical devices – Part 1: Roles, responsibilities and activities
Published by IEC on October 1, 2010
Recognizing that MEDICAL DEVICES are incorporated into IT-NETWORKS to achieve desirable benefits (for example, INTEROPERABILITY), this international standard defines the roles, responsibilities and...
This document references:
ISO TR 17791 - Health informatics - Guidance on standards for enabling safety in health software
Published by ISO on December 15, 2013
A description is not available for this item.
This document references:
ISO TR 17791 - Health informatics - Guidance on standards for enabling safety in health software
Published by ISO on December 15, 2013
A description is not available for this item.
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:
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:
IEC 80001-1 - Application of risk management for IT-networks incorporating medical devices – Part 1: Roles, responsibilities and activities
Published by IEC on October 1, 2010
Recognizing that MEDICAL DEVICES are incorporated into IT-NETWORKS to achieve desirable benefits (for example, INTEROPERABILITY), this international standard defines the roles, responsibilities and...
This document references:
ISO TR 17791 - Health informatics - Guidance on standards for enabling safety in health software
Published by ISO on December 15, 2013
A description is not available for this item.
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