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PCB Tech
Skills for obtaining high-quality medical grade PCBs
PCB Tech
Skills for obtaining high-quality medical grade PCBs

Skills for obtaining high-quality medical grade PCBs

2021-11-11
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Author:Downs

Don't know how to design and obtain high-quality PCB? Printed circuit boards or PCBs can be used in many fields. You will see it in almost every industry. They are also very popular in the medical industry. Did you know that they are an important part of high-end medical equipment? Medical grade PCB has extremely high precision and accuracy. Any medical-grade PCB design should be easy to test and debug-because there is no room for fault tolerance.

Knowing how to design medical grade PCB is necessary. It helps to get the best PCB for your equipment.

Medical grade PCB design standards

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

Monitoring equipment and testing machines help medical manufacturers comply with standards. The products they produce exceed or at least equal the recognized industry standards. There may be many potential hazards in the use of inferior products.

There is no room for error. The designers and manufacturers of PCB boards need to abide by the rules and requirements. The committee makes these rules and regulations.

Planning and design for easy assembly and maintainability

pcb board

Many factors are essential when designing a PCB. Design parameters may vary. However, if you want easy assembly/disassembly and maintainability, this will help.

Service is essential. It helps to achieve the output required by medical equipment and machines. Accuracy and precision are essential for the correct diagnosis of the test machine). Devices that perform complex operations require high-density interconnected medical PCBs. This material can help with testing, life support or monitoring.

These PCBs contain a large number of connections in a small space. Many equipment professionals also prefer medical-grade PCBs that combine rigid and flexible. The rigid-flex PCB can be installed in a small compartment of the device. In addition, they are resistant to damage.

In medical PCB design standards, we must attach great importance to this.

Medical electronic equipment design knowledge

Understand the normal functions and requirements of the target medical electronic equipment. Medical PCB requirements may vary by function. Medical-grade PCBs with higher thickness are essential for high heat dissipation. The included industry standards are a good reference point. It helps to correctly analyze and design your medical grade PCB.

High-quality manufacturers of medical-grade PCBs comply with the following rules and regulations:

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

2 US FDA 21 CFR Part 807: Applicable to manufacturing companies or companies selling imported medical devices in the United States. It also includes companies that repackage/relabel.

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 equipment. We can be used for measurement and control in medical laboratories

1 IPC 6011: It discusses the overall performance specifications of printed boards.

2 ISO 13485 Medical Devices: Supervision and operation of health management systems.

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

Regarding these regulations, you can design more compliant medical PCB equipment.

Discard uncertain components

Designing a medical-grade PCB requires a lot of hard work. You need knowledge about theory and practical applications. There is also a lot of room for innovation.

It is best to exclude trial and error from the equation. You can't take risks with medical-grade PCBs-things often happen at the same time. You can opt out of content you are not sure about. And, don't forget the golden rule of electronic products-avoid open circuits.

This will help if you learn to discard uncertain components and avoid taking up your space.

Strict requirements for PCB circuit board materials and specifications

As far as the entire medical industry is concerned, human lives are at risk. Medical equipment manufacturing is no exception. Misdiagnosis, monitoring, or support may spell DOOM in capital letters. The entire industry follows strict protocols in the manufacturing process. These contracts are mandatory for medical-grade correct PCB service providers. Fortunately, there are also various PCB manufacturing.

You can distinguish PCBs based on several parameters, such as:

• PCB shape

Medical-grade PCBs usually have two shapes-rectangular and circular. Some manufacturers offer custom-shaped PCB options. It all depends on the customer's requirements.

• Substrate used

Choose the right substrate for your design. It is essential in medical-grade PCB design. The classification is as follows:

① RoHS compliance.

②High-speed digital conversion.

③ High frequency radio frequency.

④ Temperature.

⑤ Coating and cladding.

Industry standard PCB substrates include Copper Core, RO4003C, domestic Shengyi PI, etc.

High-density interconnect boards or HDI boards have more circuit connections. You won't find so many in traditional circuit boards. On the one hand, they contain links throughout the PCB (including blind spots and buried spots). The micro-via can reach a diameter level of less than 0.006.

There are six types of HDI boards available—many are medical grade PCBs. Some even have vias connecting from one surface to another. They do this through via-connections. In addition, there are usually more than two layers of HDI. But don’t worry. You can connect them through vias and passive non-electronic layers. With the help of the layered pair, the structure adopts a coreless method.

The advantages of using HDI in medical-grade PCBs are shape efficiency and design efficiency.

TG is an abbreviation for glass transition temperature. It is a specific temperature zone. Here, the base polymer becomes a soft rubber material. The polymers used to make circuit boards must not catch fire. TG changes the hole and electron properties of the semiconductor substrate. In addition, Better TG means the superior performance of medical-grade PCBs. You have better stability and resistance to heat, humidity and chemical phenomena.

Quality working environment

The workspace environment is essential. It helps to determine the required product standards. This is why your manufacturer needs to understand product standards. PCB designers need to understand the operating location.

Temperature, pressure, humidity, air quality-everything is important. Each parameter can change the output of your medical device. In addition to these, there are more parameters.

Find a reliable manufacturer

Finding the right contract manufacturer seems to be a daunting task. More emphasis on accuracy than reliability, efficiency or economy. We need the accuracy of medical equipment and equipment. Manufacturers need to provide products that comply with medical device standards and regulations.

It is wise to prepare a questionnaire for the manufacturer. Based on their answers, you can choose a suitable contract manufacturer. This will help you get a medical grade PCB.

Questions to consider:

How long have you been in the PCB manufacturing business?

A longer time usually means a better experience. You can also expect fast delivery and industry standard follow-up.

Do you produce motherboards for other medical device companies?

Medical-grade PCBs are highly specific and task-oriented jobs. Manufacturers who have previously worked for pharmaceutical companies may perform better.

Can you avoid using fake components?

Companies that track every component involved may be more responsible. They will provide better products.

What quality assurance practices does the contract manufacturer follow?

Find out if the manufacturer is reliable and able to deliver.

What is the manufacturing test method? How will they ensure PCB quality and compliance with IPC?

Medical-grade PCBs especially require advanced components.

Has the manufacturer passed the ISO 9001 certification?

Industry standard certification helps to gain trust.