Requirements for Manufacturing a PCB for Medical Devices

 

Design Expectations of a PCB for Medical Devices

To design a circuit board for use in medical equipment requires following PCB design best practices to produce the highest quality. These practices include:

● Selecting the highest quality parts.

● Attention to detail during circuit development to create a schematic that is logical to follow.

● Using circuit simulation and PCB analysis tools to ensure function and cut back on PCB prototyping.

● Careful component placement and trace routing during PCB layout to create a board that can be manufactured without errors.

 

Medical equipment also has to operate flawlessly, whether used in the field, operating room, or analyzing test results in a lab. Doctors, nurses, and technicians don’t have time to deal with equipment that works intermittently or not at all. Additionally, the equipment must be robust enough to work in various environments, including chemicals, fluctuating temperatures, and fluids. Another aspect of the equipment is that it must be safe to operate in these different environments without worrying that it could potentially shock the user or the patient.

 

What You Should Expect from the PCB CM Building Your Medical Equipment

Here are some of the capabilities you should expect from a circuit board manufacturer to build your medical equipment circuit boards:

 

Quality:

The PCB CM you use to build your medical electronics must have a reputation for quality and the production capabilities to produce high-quality circuit boards. They need to be able to provide the front-end engineering to ensure your design is ready for manufacturing and the facilities and skilled personnel to build the product.

 

Certifications:

There are different standards for different industries, but at a minimum, a PCB CM should be certified in ISO 9000 or 9001. This standard covers the quality and reliability requirements of electronics design manufacturing, and testing. PCB CMs should also be fluent in standards like IPC-A-610, which covers the acceptability of electronic assemblies, and CFR 820, which establishes a system for validating manufacturing and quality control.

 

Traceability:

We touched on traceability above, but its importance can not be overstated. The FDA enforces product identification in medical equipment, and manufacturers of medical electronics have to have a system to trace every detail of what they build. These details include parts, materials, and other aspects of manufacturing, such as test results, certificates of compliance, product configurations, and other product data. This data is necessary for product or part recalls and future enhancements made to the device. ISO 13485 specifies the criteria for tracking systems, and the PCB CM should be certified in this standard and have a tracking system in place that conforms to its requirements.

 

Reduction of hazardous materials (RoHS):

Electronics sold in the European Union are now required to be built lead-free. The PCB CM building your medical equipment should have a lead-free manufacturing process that is completely isolated from their regular soldering processes.

 

Contact Mintec to find out how we can help you with your next medical equipment project.