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Transforming Requirements of IEC 80001-1 into an ISO/IEC 15504-2 Compliant Process Reference Model and Process Assessment Model

MacMahon, Silvana Togneri and Mc Caffery, Fergal and Keenan, Frank (2013) Transforming Requirements of IEC 80001-1 into an ISO/IEC 15504-2 Compliant Process Reference Model and Process Assessment Model. EuroSPI. 1.1-1.8.

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Abstract

Efficiencies in patient care can be achieved through interoperability of medical devices. Patient safety is the key concern during the design and manufacture of medical devices with medical devices being subject to stringent regulation in the region in which the device is to be marketed. However, with medical devices increasingly being designed to be incorporated into an IT network, the process of networking the device can introduce risks that may not have been considered during the design and manufacture stage. IEC 80001-1 was developed to address the risks associated with the incorporation of a medical device into an IT network. This paper presents how the requirements of IEC 80001-1 were used to develop a Process Reference Model (PRM) and Process Assessment Model (PAM) which are compliant with the requirements for PRMs and PAMs as outlined in ISO/IEC 15504-2.

Item Type: Article
Uncontrolled Keywords: Medical devices; IEC 80001-1; Patient care; Patient safety; Process Reference Model (PRM); Process Assessment Model (PAM); ISO/IEC 15504-2.
Subjects: Science
Research Centres: Regulated Software Research Centre
Depositing User: Sean McGreal
Date Deposited: 23 Sep 2015 10:34
Last Modified: 23 Sep 2015 10:34
License: Creative Commons: Attribution-Noncommercial-Share Alike 4.0
URI: http://eprints.dkit.ie/id/eprint/482

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