International Standard Community

The RSRC has a strong record of collaboration with various groups within the International Standards Community.

Members of the Regulated Software Research Centre serve as authors, editors and International Project Leaders on a number of technical reports. These technical reports focus on medical IT networks and medical device software development lifecycle processes. A list of technical reports is provided below:

IEC/TR 80002-3:2014 Medical device software -- Part 3: Process reference model of medical device software life cycle processes (IEC 62304)

Project Leader: Dr Fergal McCaffery

 

ISO/TR 80001-2-7:2015 Application of risk management for IT-networks incorporating medical devices -- Application guidance -- Part 2-7: Guidance for healthcare delivery organizations (HDOs) on how to self-assess their conformance with IEC 80001-1

Project Leader: Dr Silvana Togneri MacMahon

 

IEC/DTR 80001-2-8 Application of risk management for IT-networks incorporating medical devices -- Part 2-8: Application guidance -- Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2

Project Leader : Anita Finnegan

 

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

Project Leader: Anita Finnegan

 

IEC 80001-1:2010 Revision Application of risk management for IT-networks incorporating medical devices - - Part 1: Roles, Responsibilities and Activities - Approach to the revision and Process Aspects

Project Leader: Dr Silvana Togneri MacMahon (Comment Resolution on CD Draft - Scheduled for publication 2020)