There is one thing that is an absolute must for a medical device（Medical pcb assembly）: it must work as expected and it must work correctly every time it is used. There’s no excuse for a defibrillator not working as expected, and a surgeon can’t be shocked when an instrument malfunctions while performing delicate surgery. For this reason, medical devices are manufactured to some of the strictest and most demanding standards in manufacturing.
These exacting standards also apply to the printed circuit boards that are at the heart of these medical devices. These standards control how PCBs are manufactured, documented, tracked, tested and inspected. The key to getting your medical device certified to all the regulatory standards necessary to bring your product to market is to use a PCB Contract Manufacturer (CM) that understands and adheres to these standards. Here’s how medical device standards and regulations affect medical device PCB manufacturing and what you need to know when working with a PCB CM.
Different Medical pcb assembly Standards and Regulations
There are many different standards for manufacturing printed circuit boards, and the standard that applies to your particular board depends on the target market for which the board was designed. There are automotive standards, communications standards, and many others. For the medical industry, there are also specific standards, but as with all electronics manufacturing, there are some basic assembly standards. Here are some of the standards that your contract manufacturer may use:
ISO 9000:
The International Organization for Standardization publishes a variety of standards, of which the 9000 series covers quality and reliability requirements for design, manufacturing, and testing. Typically, a CM will be certified to one of the ISO 9000 standards, with ISO 9001 being the most likely.
IPC: The Institute of the Electronics Industry, also known as IPC, publishes a series of standards for circuit boards. IPC-A-600 covers PCB acceptability, IPC-6012 covers PCB qualification and performance specifications, IPC-A-610 covers acceptability of electronic assemblies, and there are many other IPC standards for enclosures, cables and harnesses, and soldering.
FDA: The U.S. Food and Drug Administration issued 21 CFR 820, a quality system regulation for validating manufacturing and quality control processes.
These are the more common standards that CM will use. There may be others that apply to specific areas or types of medical devices being manufactured.
Quality management standards when building medical PCBAs: ISO 13485
Medical PCB ISO 13485 is one of the most important standards for CM to be certified to. It is a quality management system standard for devices manufactured for the medical industry. The standard is aligned with parts of the ISO 9000 series of standards, but goes into greater depth in defining the quality and reliability requirements for medical products. It is also more aligned with other regulatory requirements in the United States, Australia, Canada and Japan.
One of the key elements of ISO 13495 is that it defines a standard for CMs to develop a documented process to track all components and materials used in PCB manufacturing. With such a process in place, your CM will be able to report back to you on everything used to build the board. This is critical in the medical industry, where manufacturers need to be aware of the recall procedures for components and materials and be prepared to comply with the process for any recalls or other related regulations.
Here are some other highlights of ISO 13485:
Documented Quality Control Processes: ISO 13485 certification requires clearly documented quality control processes for all phases of manufacturing. This ensures that products are manufactured in compliance with healthcare industry regulations.
Risk Management and Design Controls: Processes must be in place to avoid issues that could impact manufacturing. For example, the bill of materials (BOM) is reviewed to locate and replace components that may become obsolete during the product life cycle.
Process Analysis: Another requirement of certification is that manufacturers develop audit and feedback systems to monitor their performance. This allows data to be analyzed to correct and improve their processes as necessary.
Communication and Awareness of Other Regulations: Another part of obtaining ISO 13485 certification is that it requires CMs to incorporate communication and awareness of other regulatory requirements as part of their management processes. This will enable your CM to produce products that ultimately meet the requirements of the different regulatory bodies you work with.
By fully understanding and being certified to the ISO 13485 standard, your CM will have the proper processes in place to manufacture boards that pass the stringent requirements of the medical industry.
Build Your PCBA with a CM Certified to Medical Industry Standards
Not all standards require contract manufacturers to be certified to produce medical products. For example, ISO 13485 itself does not require certification, and many manufacturers benefit from simply following the standard. But having these certifications shows regulators and customers that the CM is fully invested in the standard and has the necessary systems and processes in place to meet all of its requirements.