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First ever Medical PCB Standard released – tightening the grip on compliance and traceability
The very first Medical PCB Standard contains some exclusive, innovative and strict demands – all forced forward by more advanced and smaller PCBs, and the need for compliance and traceability down to PCB level.
This summer the task group for the IPC 6012 Medical Device Addendum released the new IPC Medical Standard for Printed Circuits, after the idea was launched early 2016. The focus is on compliance, traceability and a new design level for printed circuits with a track and gap below 50 microns.
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. The IPC 6012 Medical Device Addendum passed the ballot after Industry review just before summer, now it’s launched and ready to be implemented.
How is this standard standing out from other PCB related standards?
Three key words can summarise how the IPC 6012EM stands out from other standards: Compliance, Traceability and Design level D.
“All the three are equally important to meet the future expectations and increase the use of collective requirements instead of all the customer specific ones”, says Pedersen.
When working on the standard the group faced some challenges with terminology. How to name different sections and PCBs, like Micro PCBs, and different Design Producibility Levels.
“For the different design levels we had to suggest a completely new level due to the complexity for Medical Device Applications, the Level D. We analyzed 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 needed to be analyzed and discussed in the Task Group.
Design Level D – track and gap below 50 micron
Micro PBC was a terminology in need of a discussion and also the root cause forcing forward the new design level. For the IPC 6012EM the focus has been towards medical device applications with HDI design, also called Micro PCB, often found in hearing aids or pacemakers.
“We see numerous PCB designs that are way below the standardized design levels, however there are many manufacturers producing them, still very few talking about it. It seems that many have the impression very few PCBs are produced with 75 micron track and gap. The truth is that quite a lot of the Micro PCBs are often below 60 micron, in fact many are way below 50 micron as well. This forced forward the need for a new design level – the design level D”, says Pedersen
The IPC 6012EM is the first to address this terminology and the advanced design levels.
So what are the IPC Design Producibility levels?
In the IPC-2220 series, IPC refers to Design Producibility levels of features, tolerances, measurements, assembly, testing of completion or verification of the manufacturing process, that reflect progressive increases in the sophistication of tooling, materials or processing, and, therefore progressive increases in fabrication cost. These levels are:
Level A General Design Producibility – Preferred
Level B Moderate Design Producibility – Standard
Level C Least Design Producibility – Reduced
The new proposed level suggested due to the complexity in the PCBs for Medical device Applications is called:
Level D: Advanced Design Producibility – Exceedingly Reduced
The producibility levels shall not to be interpreted as a design requirement, but rather as a method of communicating the degree of difficulty.
Today these PCBs are made to customer requirements rather than following the IPC standard, this is not the path we want to continue on.
Traceability on all materials, processes and production of the PCB
Another uniqueness about the standard is the focus on traceability in accordance with IPC 1782 level 4. This is strangely enough the first standard with demands for traceability to the PCBs on materials, processes and production. A feature Pedersen hopes and believes we will see incorporated in other standards as well.
“With an increased focus on cyber security and documentation in many industries, like the new CMMC regulations in the Defence industry, the need for traceability is forced forward. This also flows down to PCB level. In an industry such as the Medical one, the need for reliability is crucial, thus also the ability to trace all elements in the PCB production”, says Pedersen.
Why is a digital specification the only way to go?
This is why the Medical Addendum is the first to include the demand that to be able to secure compliance to product performance in the Medical Device Application, a computer readable Digital Specification shall be created during the product development process. The Digital Specification shall specify the product requirements in all printed board procurement stages between buyer and seller through the complete product lifecycle.
“At Elmatica we say: Compliance in, is compliance out. With digitalization, AI and IoT, the traceability and transparency to where, by whom and how a PCB is produced will be even more important, compliance is on the map to stay and offers the ability to rule out the ones that don’t follow the standard. This is why the Digital Specification shall be used in Request for Quotations to protect the buyer and secures that the seller has sufficient capability to meet the qualifications and requirements needed”, says Pedersen.
In what way will this standard affect the PCB Industry?
“We are extremely content with the release of the new standard. Developing standards is a time consuming and detailed process, in particular for the Medical Industry, due to the complexity in Medical PCBs”, says Elmaticas Chair of the Medical Addendum Task group”, Jan Pedersen.
With the new standard, the designers and manufacturers of PCB for medical devices can rely on specific parameters and requirements for production, which again will increase the reliability and transparency.
What is its purpose?
The purpose of this specification is to provide requirements for qualification and performance of Printed Boards for High Reliability Medical Device Applications. This specification covers Rigid Printed Boards that may have a design that contains HDI and Design Level D density with special requirements to production, test and qualifications.
The Addendum provides requirements to production, test and qualification.
There are today 44 members in the task group, representing the PCB Industry, Electronic manufacturing and Medical Device Applications industry. The task group is still open to new members. Jan Pedersen has one encouragement towards the industry:
“We need more people from product owners or Electronic production for Medical Device Applications, come join us and share your valued knowledge, making standards even more accurate and up to date”, says Pedersen.
The Task Group currently works on the IPC 6012 EA – the standard is expected to be released at APEX 2021.
The term “Micro PCB”
A “Micro PCB” is a new term we recently had a discussion with members of the IPC TAEC (Technical Activities Executive Committee) around and ended up with a completely new terminology for it. We call it Design Producibility level D, which in reality means we push IPC design standards (IPC-2220 series) to be more up to date. This will take time to implement globally within IPC, but thanks to the miniaturization in some Medical Device Applications these standards will be the first ones to use the new term.
This article was first published on the Institute of Circuit Technology website.