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BSI - BS PD IEC/TR 80001-2-1

Application of risk management for IT-networks incorporating medical devices Part 2-1: Step-by-step risk management of medical IT-networks - Practical applications and examples

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Organization: BSI
Publication Date: 31 October 2012
Status: active
Page Count: 70
ICS Code (IT applications in health care technology): 35.240.80
ICS Code (Medical equipment in general): 11.040.01

Document History

BS PD IEC/TR 80001-2-1
October 31, 2012
Application of risk management for IT-networks incorporating medical devices Part 2-1: Step-by-step risk management of medical IT-networks - Practical applications and examples
A description is not available for this item.

References

This document references:
IEC 60601-1-2 - Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
Published by IEC on September 1, 2020
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS....
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/TR 80001-2-2 - Application of risk management for IT-networks incorporating medical devices – Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
Published by IEC on July 1, 2012
This part of IEC 80001 creates a framework for the disclosure of security-related capabilities and RISKS necessary for managing the RISK in connecting MEDICAL DEVICES to IT-NETWORKS and for the...
This document references:
IEC/TR 80001-2-3 - Application of risk management for IT-networks incorporating medical devices – Part 2-3: Guidance for wireless networks
Published by IEC on July 1, 2012
This part of IEC 80001 supports the HDO in the RISK MANAGEMENT of MEDICAL IT-NETWORKS that incorporate one or more wireless links. The report provides technical background concerning wireless...
This document references:
ISO TS 19218-2 - Medical devices - Hierarchical coding structure for adverse events - Part 2: Evaluation codes
Published by ISO on April 1, 2012
This part of ISO 19218 specifies requirements for a hierarchical coding structure for characterizing the results of the analysis or evaluation of adverse events relating to medical devices. The codes...
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