scope:

This Specification covers qualification and performance requirements of Rigid Printed Board for Medical Device Applications. The Printed Boards may have a design that contains HDI and Design Level D density with special requirements to production, test and qualification.

This addendum provides requirements to be used in addition to, and in some cases, in place of, those published in IPC-6012E to ensure the reliability of printed boards that must meet requirements to High Reliability Medical Applications described as IPC Class 3 under section 0.1.5 of this Addendum.

Purpose

The purpose of this specification is to provide requirements for qualification and performance of Printed Boards for High Reliability Medical Device Applications. The requirements written in this document support regulatory guidance provided by the United States Food and Drug Administration (FDA) and Medical Device Directives.