Assessment of Reliability Standards for Implantable Medical Electronics


Bill Bader, iNEMI


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)


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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