Medical Device PCB Standard Reaches New Milestone


Reading time ( words)

Recently the IPC 6012 Medical Device Addendum reached a new milestone, passing the ballot after Industry review. 

“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”, says Elmatica’s Chair of the Medical Addendum Task group, Jan Pedersen.

In 2016 Elmatica initiated a task group for Medical Applications. IPC accepted the challenge and founded IPC-6012 and 6013 Medical Addendum with Jan Pedersen as Chair.

Different industries require different standard settings

“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,” says Pedersen.

Imperfections in materials that would be acceptable in other industries, may cause application failures in Medical Devices, same goes for what test frequency waivers are accepted within the industry, all factors that need to be analyzed and discussed in the Task Group.

One down - one to go with the IPC 6013EM

“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”, says Pedersen. 

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

Share

Print


Suggested Items

I-Connect007 Editor’s Choice: Five Must-Reads for the Week

04/30/2021 | Nolan Johnson, I-Connect007
This week’s biggest news came in the form of industry briefings—there were a lot of them and the news was universally positive. The news you need to read for this week includes three reports from IPC detailing: the strength and risks in the global economic recovery; a strong EMS book-to-bill ratio; and strong North American PCB sales. Zeroing in on a single company, Apple reported a significant jump in revenue.

I-Connect007 Editor’s Choice: Five Must-Reads for the Week

04/23/2021 | Andy Shaughnessy, I-Connect007
This week, we bring you a wide swath of news, columns, and articles from the past week. Altium announced a new cloud platform that connects design stakeholders with users of its Altium 365 environment. Cadence Design Systems has acquired a company that develops computational fluid dynamics technology to help expand its system analysis offerings.

A Show Full of Opportunities

04/16/2021 | Tara Dunn, Averatek
Looking back to my notes from IPC APEX 2020, I noticed one of my comments: There were so many interesting sessions that I often found myself in the position of choosing between several that I wanted to attend in the same timeslot. This year was not any different in that regard. I am purposely glossing over the fact that I, like many of my friends, missed the camaraderie and opportunity to catch up in person while attending these technical sessions, and I look forward to being able to do that next year.



Copyright © 2021 I-Connect007. All rights reserved.