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Assessment of Reliability Standards for Implantable Medical Electronics

Presenter:

Bill Bader, iNEMI

Authors:

John C. McNulty (Exponent), Kevin Knadle (i3), Hans-Peter Klein (Dyconex), Torsten Harnisch (Biotronik), Enrico Dona (MED), Werner Meskens (Cochlear), Maaike Op de Beeck (iMec), and Jason Coder (NIST)

Description:

The Reliability Requirements for Implantable Medical Devices Project focused on defining requirements for implantable reliability specifications (specifically, FDA class 3 devices). This paper reports on the project’s review of existing reliability, quality and safety standards specific to implantable electronic devices. It includes the results of an industry survey of commonly used/modified test standards, and makes recommendations regarding test standards to be developed.  (ICEP 2015, Kyoto, Japan.)

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