5 Rules to Produce High-Quality PCBs for Medical Equipment
Producing quality PCBs is always beneficial no matter what they are used in; however, the necessary quality standards are fundamental when dealing with PCBs that will be used in medical equipment, as they directly affect human health care.
As one of the most critical applications of PCBs, medical PCB assembly requires the utmost care and attention to detail, especially since there are stringent regulatory standards that companies must meet. These standards control and manage how PCB fabrication is completed and how the PCBs are documented, tracked, and evaluated throughout the production process.
There are several important factors to consider during the design and production of medical PCBs, including consistency, safety, convenience, and lifespan. Since medical equipment must provide reliable output whenever used, as human lives often depend on it, precision is essential in medical PCB design.
Especially when it comes to medical devices that are wearable or implantable, protecting patients' safety is paramount, which is why medical PCBs should be designed to account for risks posed by extreme weather or vibrations.
User-friendliness is another crucial aspect of medical PCB design, as more complex or inaccessible products will pose problems. Lifespan and durability are also important for medical PCBs since equipment failure could lead to catastrophic outcomes.
What are the regulations and standards for medical equipment PCB production?
The regulations and standards for medical PCB production vary between different regulatory authorities.
The Institute for Printed Circuits (IPC), the International Organization for Standardization (ISO), and the U.S. Food and Drug Administration (FDA) are just a few of the standard organizations that have regulations that many medical PCB manufacturers adhere to.
Some of the following regulations and standards are pretty common concerning medical PCB production:
Choosing a Certified Contract Manufacturer
Choosing to work with a certified contract manufacturer is highly recommended when producing medical PCBs.
Experienced contract manufacturers can help you make proper decisions during the selection of components and materials, provide design for manufacturing reviews, and suggest the best production practices that adhere to regulatory standards to overcome the challenges of building successful medical equipment.
An industry-certified contract manufacturer will also address all relevant concerns related to planned and controlled PCB manufacturing and assembly processes.
Following a Set Schedule
Any contract manufacturer specializing in medical PCB production must develop a detailed production schedule and stick to it throughout the process.
For offices to stay ahead of the increased demand for new medical devices, contract manufacturers need to track and control their entire production line while running rapid prototyping with efficient ramp-up capabilities.
A well-organized schedule will help an experienced contract manufacturer to do this and to achieve high production yields.
Following Regulatory Standards
It is mandatory to adhere to ISO 9001 quality standards and IPC-A-610 acceptability standards during medical PCB assembly.
Having medical PCBs manufactured by ISO 13485-certified manufacturers helps ensure the traceability of parts and materials used to produce medical devices and necessitates detailed documentation for additional reference.
Adhering to IEC 60601-1 guidelines will ensure that standard aspects of medical equipment are correctly manufactured to maximize safety and functionality.
Following Proper Regulatory Testing and Certification Procedures
Medical PCBs are subject to rigorous testing and inspection to meet predictability, reliability, and safety requirements. One common regulatory standard certification test is IEC 60601-1, which mainly focuses on whether or not there is any potential for signal failure that could cause risks to an operator/patient.
When it comes to medical equipment that is in a lab, IEC 61010 certification is necessary for ensuring safety.
Following Component Traceability Standards
In all medical devices, every material, cable, and component used inside must be fully traceable so that these parts can be traced back and easily replaced in case of a device failure. It is also necessary that device components do not contain lead or other hazardous materials.
How Circuits Central Can Help You Meet Regulations and Standards for Medical Equipment PCB Production
If you are seeking a top-quality medical equipment manufacturer in Toronto, Circuits Central has the qualifications, experience, and facilities to provide you with everything you need.
We have experience working with some of the industry's most prominent medical device designers, innovators, and contractors. We have helped them by delivering compliant, reliable, accurate, and cost-effective medical PCB production solutions. Our ultimate goal is to save lives by assisting in developing medical devices of the highest quality.
We always keep patient safety in mind during manufacturing and maintain adherence to various regulatory standards to create ideal products for medical applications. Our team can work with you to ensure that your products meet the required certification.
We conduct regular audits and inspections to ensure compliance and product quality with particular attention to ISO certification and FDA-registered manufacturing facility and Quality System compliance. Our company can also guarantee IPC class 3 PCBs for prototyping and bulk production, class 100,000 Clean Room (with capabilities up to class 10,000), and the use of certified class 100 Laminar Flow Hoods.
Our turnkey PCB assembly process will also make it incredibly easy for you to take care of all your PCB production needs in one place, as we will handle everything from verifying design files to prototyping to PCB assembly to cable assembly to product testing. In the end, your satisfaction with your expertly printed PCBs is guaranteed.