Medical PCB assembly: Know these regulations and standards

by Ken Ghadia, Sales Engineer, TechnoTronix

The reliability and safety of Medical PCB assembly are of utmost importance as they directly impact human healthcare. It is one of the most critical applications that demand the best PCB performance. Setting stringent regulatory standards is compulsory in medical device manufacturing.

The standards also apply to the printed circuit boards used in medical devices. They are used to control how the PCB fabrication is done how PCBs are built, documented, tracked, and evaluated throughout the process. Different regulatory authorities have prescribed their own set of standard rules to follow. Institute for Printed Circuits (IPC), currently known as the Association Connecting the Electronics Industries, International Organization for Standardization (ISO), and the U.S Food and Drug Administration (FDA), are some of the standard organizations followed by Medical PCB manufacturers.

Factors to be considered while designing and assembling medical PCBs:

Consistency – The prime requirement of a Medical PCB is to provide reliable output each time it is used, as it can affect human life. Hence precision is an important factor in designing a medical PCB.
Safety – Some medical devices are used as wearable or implantable tiny circuits on the human body. Protecting the patient against any hazards due to extreme temperature or vibration is a basic requirement in the medical PCB design.
Convenience – User-friendliness is an essential factor while designing a medical PCB. The easy accessibility and durability of the product have a significant impact and have to be considered here.
Lifespan – On-board battery or power design has to be done efficiently to ensure a long lifespan of the medical equipment. Understanding the frequent failure points and designing a robust product can improve the device’s lifetime.

We can address all the above factors by following the medical PCB standards and regulations.

Overview of the Standards and Regulations for Medical PCB assembly:
Medical devices are used for various healthcare purposes like monitoring, diagnosis, surgical procedures, etc. The regulatory requirements for these designs are very rigorous. But some of the basic PCB assembly standards should also be followed along with the specific guidelines. Regulatory bodies like IPC, ISO, and FDA have put forward many rules for medical PCBs. We shall discuss them below:

IPC

The association connecting the electronics industries publishes the standards for the assembly and production of electronic products. Some of the standards related to PCB assembly are:

IPC–A-600: This standard describes the target, acceptable and nonconforming conditions on printed circuit boards.
IPC-A–6012: This standard specifies the performance and qualification requirements for rigid PCB fabrication.
IPC-A-610: This is the most commonly used inspection standard that regulates the acceptability of electronic assemblies.
IPC-A-620: This standard recommends practices and requirements for cable manufacturing, wire, and harness assemblies.
IPC-A-630: This standard provides an acceptability standard for manufacturing, inspection, and testing electronic enclosures.

ISO

The ISO 9000 standard provides detailed quality and reliability requirements for PCB design, manufacturing, and testing. Original equipment manufacturers (OEM) should be certified in the ISO 9000 standard against the safety and functionality of medical equipment.

FDA

The U.S Food and Drug Administration has its branch, the Centre for devices and radiological health (CDRH), responsible for approving medical devices by supervising the manufacturing, functionality, and safety of the devices. FDA has outlined the manufacturing and quality system regulation requirements in 21CFR820 for medical devices.

These are the common standards followed by the OEMs and contract manufacturers building medical PCBs for the healthcare sector. To focus on the quality and reliability of medical devices, ISO has released a standard for quality management while building medical PCB assemblies.

Quality Management System (QMS) for Medical PCB assembly
ISO 13485 elaborates the QMS fundamentals defined in ISO 9001 standard for medical device designers and manufacturers. It provides a detailed list of requirements regarding design, development, testing, traceability, and documentation during production.

ISO 13485:2016 is the latest version which is aligned with the FDA quality regulations as well. Medical PCB manufacturers are hugely benefited by implementing this standard as it serves as an assurance for the safety and quality of the product.

CMs who are certified for this standard can bring in more advantages. They understand the product requirements clearly and prevent common manufacturing mistakes. They follow a transparent auditing process to ensure high quality. Well-maintained documentation for tracking all materials and components can prove significant, as a certified CM understands the recall process for materials or components in medical equipment manufacturing.

Successfully conforming with the ISO 13485 standard requirements depends on the CM’s process quality. Medical PCB manufacturers have to seek CM support in the design and development process as follows:

Establish good communication from the early design stage itself
Obtain DFM guidelines compatible with the CM assembly line equipment
Create strategies to handle component shortages and methods to identify fake components in advance
Enlist the material and component tracking methods followed by the CM

It is necessary to optimize the board fabrication with precise component selection to follow the ISO 13485 standard completely. Selecting the right CM is crucial while building Medical PCBs after completing the Medical PCB Prototyping. There are regulatory standards to be followed in testing, based on the type of the medical device like implantable device or diagnostics device.

ISO 13485 standard ensures risk management, design control, process analysis, and documentation for quality control. A certified CM shall implement a traceability and auditing system according to quality management guidelines. They shall monitor the input and output at each manufacturing stage to assess the quality. Collaborating with a certified CM will ensure achieving the regulatory compliance required for a medical PCB assembly.