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




Suggested Items

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

09/23/2022 | Andy Shaughnessy, Design007 Magazine
It’s officially fall now, and in Atlanta the temperature has plummeted to the mid-80s. We’ve all bumped our air conditioners up to 74 degrees. That means it’s trade show season, and I’ve been busy looking for my suitcase. This week, we have an assortment of news about associations, education, and advocacy, as well as another installment of our Printed Electronics Roundtable. And if you’re looking for a job, you are in luck; our jobConnect007 section is chock-full of open positions at all levels in this industry.

IPC: Companies Are Intentional About Tracking Environmental and Social Risks

09/22/2022 | Suhani Chitalia and Kelly Scanlon, IPC
Leading companies in the electronics manufacturing industry are highly intentional about their environmental, social and governance (ESG) priorities, with climate change and energy use among the most closely scrutinized issues, an IPC analysis shows. As part of IPC’s ESG for Electronics initiative, IPC is interested in developing resources for members on the most common ESG methods and priorities of leading companies across the electronics value chain. In support of this, IPC has preliminarily analyzed the ESG reports of approximately a dozen companies in selected portions of the industry.

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

09/09/2022 | Andy Shaughnessy, I-Connect007
It feels like the first day of school. It’s September, and we’re all officially back at our desks, workstations, or kitchen tables. Even Les Vacances is over. Oui, c’est vrai! But instead of facing new teachers, we have to deal with diverse market forces, supply chain issues, and technology that never seems to stop evolving. Of course, that’s what makes this industry so interesting, isn’t it?



Copyright © 2022 I-Connect007. All rights reserved.