International Software Standards Update Nov 2006

Sherman Eagles, a Medtronic Standards representative and co-chair of the AAMI software committee, gave a presentation on changes and new developments in software standards at the Nov 2006 Advamed conference.

This presentation is at the link provided. It addresses the withdrawal of ISO/IEC 60601-1-4 and the incorporation of Programmable Electronic Medical Systems (PEMS) into the basic requirements of ISO 14971. It also stresses new concerns, requirements, and standards related to network connected devices to be covered in device risk management and mentions a new standard under development: IEC 80001: Application of risk management to information technology (IT) networks incorporating medical devices. The presentations also describes the Global Harmonization Task Force’s new software working group and the Healthcare Technology Task Force (HTTF).

SEagles Standards Update Advamed 1106

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