There’s a new IEC/TR 80001-2-5, “Application of risk management for IT-networks incorporating medical devices – Part 2-5: Application guidance – Guidance on distributed alarm systems.” This new publication extends the series on safeguarding computer networks that include medical devices. It can be purchased in paper format, for pdf download or as part of a multi-user online subscription service from Document Center Inc.
The IEC 80001-2 Series addresses the issue of risk management for networked medical devices in general and this new part specifically deals with the issue of alarms. To set up your networked alarm system, you’ll need to know how to identify hazards and the causes for them. Then you’ll need to identify, implement, and verify your risk controls.
How will you know that this new Technical Report applies to your situation? The essential requirement for using the standard is that your alarm system involves at least one medical device and a communication path that uses an IT (Information Technology) network.
What’s covered by the IEC/TR 80001-2-5? Of course, there’s the usual scope, referenced documents and definitions sections. In this case, the clause for terms and definitions is especially lengthy, since having a common meaning to the various terms will assist you in understanding the balance of the document.
Next Clause 4 reviews the functions that this type of alarm system provides. Clause 5 provides the basis of determining of the type of system you’ll be using. And Clause 6 covers the issues that your risk management program for your alarm system needs to address.
There’s an additional four Annexes provided in this document. The first, Annex A, shows you the relationship of this technical report to IEC 60601-1-8. Annex B discusses the various types of sources that might generate the alarm state. Annex C reviews what types of systems are appropriate for various conditions. And Annex D covers the issue of scalability. Lastly, an 18-item bibliography finishes off the publication along with a 2-page index of terms used.
FYI: There are a total of 6 Parts to this series currently available. Additionally, Part 7 and Part 8 are in preparation at this time.
Now you’ll need to get a copy. Go to Document Center’s webstore at www.document-center.com and order your authorized copy now. Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’ll be able to help you with this and any other standards-related requirements you may have. Make us your Standards Experts!
