Which OS for IEC 62304 Medical Systems?

August 2012
9 pages

Which OS for IEC 62304 Medical Systems?

This paper is for anyone who must select an OS for a safety-critical medical system. It provides information to help with estimates of the real cost of choosing a Linux or QNX OS. It lists requirements identified by standards such as IEC 62304, ISO 14971 and IEC 61508, and offers comparative estimates of the effort required to meet these requirements. These estimates are for initial certification and pre-approval, subsequent re-certifications following OS upgrades, and ongoing costs.

Contents

Introduction — Criteria for comparison — Method and assumptions — Estimation of effort — References and activities — Summary of estimated effort [+]

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Author
Chris Hobbs
chobbs@qnx.com

Chris Hobbs

Chris Hobbs is a kernel developer at QNX, specializing in "sufficiently-available" software: software created with the minimum development effort to meet the availability and reliability needs of the customer; and in producing safe software (in conformance with IEC61508 SIL3). He is also a specialist in WBEM/CIM device, network and service management, and the author of A Practical Approach to WBEM/CIM Management (2004).

In addition to his software development work, Chris is a flying instructor, a singer with a particular interest in Schubert's Lieder, and the author of several books, including Learning to Fly in Canada (2000) and The Largest Number Smaller than Five (2007). His blog, Software Musings, focuses "primarily on software and analytical philosophy".

Chris Hobbs earned a B.Sc., Honours in Pure Mathematics and Mathematical Philosophy at the University of London's Queen Mary and Westfield College.