7 Tips For Getting a High-Quality Medical Grade PCB

Medical Grade PCB Design Standards

Medical device manufacturers follow the standards set under Section 201(H) of the FD&C Act. FD&C stands for Federal Food Drug and Cosmetic Act.

Monitoring devices and testing machines help medical manufacturers follow the standards. They make products that exceed or at least are equal to the accepted industry standards. There may be several potential dangers of using inferior-grade products. 

There is no room for the slightest of errors. Designers and manufacturers of the PCB Boards need to follow the rules and mandates. The Commission sets these rules and regulations.

Plan and Design For Ease of Assembly And Serviceability

Many factors are essential while designing PCBs. The design parameters may vary. However, it would help if you looked for ease of assembly/disassembly and maintainability.

Servicing is crucial. It helps achieve the required output from medical equipment and machines. Accuracy and precision are essential for a proper diagnosis by the testing machines). Equipment that performs complex operations requires high-density interconnect medical PCB. The material can help in testing, life-support, or monitoring.

These PCBs pack in a lot of connections in a small space. Many device professionals also prefer rigid-flex Medical-grade PCBs. Rigid-flex PCBs can fit within a small compartment of the equipment. Plus, they are damage-resistant.

In medical PCB design standards, we must pay great attention to this.

Knowledge of Medical Electronic Device Design

Know the proper functioning and requirements of the target Medical Electronic Device. The medical PCB demands may vary according to the functions. Medical grade PCBs with higher thickness are essential for high heat dissipation. The incorporated industry standards are a good reference point. It helps in the proper analysis and design of your medical-grade PCB. 

A quality manufacturer of medical-grade PCB complies with the following rules and regulations:

1 FCC (Federal Communications Commission)： It is Title 47 of the Code of Federal Regulations.

2 US FDA 21 CFR Part 807: It is applicable for manufacturing firms or firms that import medical devices for sale in the US. It also includes repackaging / relabeling companies.

1 IEC 60601-1： These talk about the underlying performance and safety parameters of medical electrical equipment.

2 IEC 61010-1： These are the basic requirements for electrical devices. We can use it in medical laboratory measurement and control

1 IPC 6011: It talks about the overall Performance Specifications for Printed Boards.

2 ISO 13485 Medical Devices: Regulation and Functioning of Health Management Systems.

3 ISO 14971 Medical Devices: It helps manufacturers identify hazards and risks associated with the medical equipment. 

Concerning these regulations, you can design medical PCB equipment that is more compliant.

Abandon Uncertain Components

Designing a medical-grade PCB requires a ton of hard work. You need knowledge about both theoretical and practical applications. There is plenty of room for innovation, too.

It is better to leave trial and error out of the equation. You can’t risk it with medical-grade PCBs- where things often happen simultaneously. The content you are unsure about can opt-out. And do not forget the golden rule of Electronics- AVOID AN OPEN CIRCUIT.

It would help if you learned to give up uncertain components and avoid taking up your space.

Strict Requirements For Circuit Board Materials And Specifications

Human lives are at stake in the case of the entire medical industry. Medical equipment manufacturing is no different. Incorrect diagnosis, monitoring, or support can spell DOOM in capital letters. The whole sector follows strict protocols in the manufacturing process. The contracts are mandatory for medical-grade correct PCB service provider. Thankfully, there are various PCB manufacturing too.

You can distinguish PCB’s based on several parameters, such as:

The shape of the PCBs

Medical grade PCBs are usually available in two shapes- Rectangular and Circular. Some manufacturers offer the option of custom-shaped PCBs. It all depends on the client’s requirements. 

Base Material Used

Select the right base material for your design. It’s essential in medical-grade PCB designing. The categorization is as below:

①　RoHS Compliance.

②　High-speed Digital Conversion.

③　High-Frequency RF.

④　Temperature.

⑤　Coating and Cladding.

Industry-standard PCB Base materials include Copper Core, RO4003C, Domestic Shengyi PI, and more.

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High-density Interconnected boards, or HDI Boards, have a more significant number of circuit connections. You wouldn’t find as many in the traditional circuit boards. For one, they contain links (both blind and buried) throughout the PCBs. The micro vias can reach a diameter level of less than 0.006. 

There are six available types of HDI Boards- many as medical-grade PCBs. Some even have vias connected from one surface to the other. They do this via via-connections. Plus, there are often more than two layers of HDI. Don’t worry, though. You connect them through vias and a passive non-electric sub-layer. The construction is in a coreless manner- with the help of layered pairs. 

The advantage of using HDI in medical-grade PCBs is form-efficiency and design efficiency. 

TG is an acronym for Glass transition Temperature. It is the specific temperature region. Here, the base polymer changes to a soft rubbery material. The polymer used to make circuit boards must not catch fire. TG changes the Hole and Electron Properties of the semiconductor base. Also, Better TG means the superior performance of medical-grade PCBs. You have better stability and resistance to heat, moisture, and chemical phenomena.

Quality Work Environment

The workspace environment is essential. It helps in determining the required product standards. That’s why your manufacturer needs to know the product standards criteria. PCB designers need to understand the operating location.

Temperature, pressure, moisture, air quality – all matters. Each of the parameters can change the output of your medical equipment. There are many more parameters than just these.

Finding a Reliable Manufacturer

Finding the right contract manufacturer might seem to be a daunting task. Place greater emphasis on accuracy than reliability, efficiency, or economy. We need accuracy for medical equipment and devices. The manufacturer needs to deliver products adhering to Medical Device Standards and Regulations. 

A wise move is to prepare a questionnaire for the manufacturers. Depending upon their answers, you can select the right contract manufacturer. It’s what will help you get medical-grade PCBs.

Questions to consider:

How long have you been in the PCB Manufacturing Business?

A more extended period generally indicates a better experience. You can also expect prompt delivery and the follow-up of industrial standards.

Do you make motherboards for other medical device companies?

Medical grade PCBs are highly specific and task-oriented jobs. A manufacturer who has worked for a pharmaceutical company before is likely to perform better.

Do you have a way to avoid using fake components?

A company that keeps track of each component involved is likely to be more responsible. They will deliver better products.

What are the quality assurance practices followed by the contract manufacturer?

Figure out whether the manufacturer is reliable and able to deliver.

What are Manufacturing testing methods? How will they ensure PCB quality and adherence to IPC?

Medical-grade PCBs especially require high-grade components.

Is the manufacturer ISO 9001 certified?

An industry-standard certification helps gain trust.

Summary

Are you looking to get a medical PCB? Talk to us at WellPCB, and let us help you! We offer top-quality PCB manufacturing and PCB assembly needs as you need. Our custom solutions will ensure you get the medical PCB you need. With high-quality equipment and new infrastructure, we are ahead of the competition. 

Talk to us about your custom PCB assembly needs today!