PD IEC/TR 80001-2-9:2017 - Application of risk management for it-networks incorporating medical devices. Application guidance. Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities

PD IEC/TR 80001-2-9:2017

Application of risk management for it-networks incorporating medical devices. Application guidance. Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities

Status : Current   Published : February 2017

Format
PDF

Format
HARDCOPY



IEC TR 80001-2-9:2017(E) establishes a security case framework and provides guidance to health care delivery organizations (HDO) and medical device manufacturers (MDM) for identifying, developing, interpreting, updating and maintaining security cases for networked medical devices. Use of this part of 80001 is intended to be one of the possible means to bridge the gap between MDMs and HDOs in providing adequate information to support the HDOs risk management of IT-networks. This document leverages the requirements set out in ISO/IEC 15026-2 for the development of assurance cases. It is not intended that this security case framework will replace a risk management strategy, rather, the intention is to complement risk management and in turn provide a greater level of assurance for a medical device by:


- mapping specific risk management steps to each of the IEC TR 80001-2-2 security capabilities, identifying associated threats and vulnerabilities and presenting them in the format of a security case with the inclusion of a re-useable security pattern;


- providing guidance for the selection of appropriate security controls to establish security capabilities and presenting them as part of the security case pattern (IEC TR 80001-2-8 provides examples of such security controls);


- providing evidence to support the implementation of a security control, hence providing confidence in the establishment of each of the security capabilities.


The purpose of developing the security case is to demonstrate confidence in the establishment of IEC TR 80001-2-2 security capabilities. The quality of artifacts gathered and documented during the development of the security case is agreed and documented as part of a responsibility agreement between the relevant stakeholders. This document provides guidance for one such methodology, through the use of a specific security pattern, to develop and interpret security cases in a systematic manner.





Standard NumberPD IEC/TR 80001-2-9:2017
TitleApplication of risk management for it-networks incorporating medical devices. Application guidance. Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities
StatusCurrent
Publication Date28 February 2017
Normative References(Required to achieve compliance to this standard)IEC TR 80001-2-2:2012
Informative References(Provided for Information)IEC TR 80001-2-1:2012, IEC 80001-1:2010, ISO/IEC 15026-2:2011, IEC TR 80001-2-8:2016, IEC 60601-1:2005, ISO/IEC 15026-1:2013, IEC 80001, ISO 14971, IEC 62443-3-3, ISO/IEC 15408-2
International RelationshipsIEC/TR 80001-2-9 Ed.1.0
DescriptorsRisk assessment, Personnel, Communication networks, Data security, Technical documents, Information exchange, Health services, Risk analysis, Project management, Computer networks, Data transfer, Management, Medical equipment, Data processing
ICS11.040.01
35.240.80
CommitteeCH/62/1
ISBN978 0 580 91661 8
PublisherBSI
FormatA4
DeliveryYes
Pages40
File Size3.49 MB
Price£214.00


 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents


Worldwide Standards
We can source any standard from anywhere in the world


BSOL

The faster, easier way to work with standards


Collaborate, Innovate, Accelerate.


Customers who bought this product also bought

  • PD IEC/TR 80001-2-8:2016
    Application of risk management for IT-networks incorporating medical devices Application guidance. Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2
  • PD IEC/TR 80001-2-2:2012
    Application of risk management for IT-networks incorporating medical devices Guidance for the disclosure and communication of medical device security needs, risks and controls
  • PD IEC/TR 80001-2-3:2012
    Application of risk management for IT-networks incorporating medical devices Guidance for wireless networks
  • BS EN 80001-1:2011
    Application of risk management for IT-networks incorporating medical devices Roles, responsibilities and activities