BANNOCKBURN, IL – IPC membership has voted to accept a new addition covering medical devices to the industry standard for bare board qualification and acceptability following industry review. IPC-6012 Medical Device Addendum should be ready by the end of this summer, says the task group chairman, Jan Pedersen.

“We are extremely content with this step forward, moving us closer to industry launch. The development of PCB standards is in general a time-consuming process. The one for the Medical Addendum is no exception,” said Pedersen of Elmatica.

In 2016, Elmatica helped initiate an industry task group for medical applications. IPC then developed drafts covering medical devices for IPC-6012 and IPC-6013, the standards for rigid and flex boards, respectively.

“Developing the standard, we have had to look into all aspects and needs for medical devices, identifying PCBs used in several applications such as implants and hearing aids that have line widths, thickness, hole sizes and other features below current tolerances and limits in today’s design, performance and acceptability standard,” said Pedersen.

Imperfections in materials that would be acceptable in other industries may cause application failures in medical devices, as do test frequency waivers accepted within the industry.

“Other obstacles we have faced are terminology, how to name different sections and PCBs like micro PCBs, and different design producibility levels. For the last one, we had to suggest a new level due to the complexity for medical device applications, a completely new level: Level D.

“Developing standards is time-consuming. However, we aim for industry launch of IPC-6012EM late summer. Now we start working on IPC-6013EM, hoping for launch around November.”

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