Adhering to industry-specific rules and regulations is critical for anyone manufacturing printed circuit board assemblies (PCBAs) for medical devices. The FDA holds a unique set of requirements outlining compliance not only in medical printed circuit board manufacturing but also in recordskeeping. ISO and IPC requirements must also be followed while ensuring quality control throughout the prototyping and production cycles.
This guide explains what medical device manufacturers and the circuit producers that support them must know to develop medical PCBs and devices in compliance with all applicable standards.
Medical Device Printed Circuit Boards & Assemblies: Typical Applications
Numerous medical devices rely on printed circuit technologies, ranging from at-home monitoring tools to sophisticated diagnostic equipment. Even the smallest of implantable devices relies on medical PCBs to function. Some examples include:
- Blood pressure monitors
- Heart monitors
- Pacemakers
- Thermometers
- Cochlear implants
- Imaging and diagnostic instruments
- EMG (electromyography) activity systems
- Neurostimulators
- Handheld monitors
These devices must function precisely and reliably; even the smallest of defects could put a patient’s life at risk. For these reasons, there are several federal and industry regulations that must be adhered to by medical PCBA manufacturers and those manufacturing and testing the fully assembled device.
What Are the Regulations for Medical Device PCB Assemblies?
Authorities like the Institute for Printed Circuits (IPC), the International Organization for Standardization (ISO), and the U.S. Food and Drug Administration (FDA) have all released standards related to circuit boards used in medical equipment. The guidelines include every aspect of the development and manufacturing process, from design to final approval.
Let’s go deeper into each of these organizations and their regulations.
IPC Standards
The Institute for Printed Circuits regulates the assembly and production of electronic components and assemblies. The group has developed and released several critical standards:
- IPC-A-600: Defines acceptability requirements for PCB conductors, solder joints, hole integrity, and surface finishes.
- IPC-A-6012: Specifies the qualification and performance requirements for rigid PCBs.
- IPC-A-610: Defines the criteria for the acceptability of electronic assemblies.
- IPC-A-6013: Standards for the qualification and performance of flexible and rigid-flexible circuit boards.
- J-STD-001: A standard specifying materials, processes, and verification requirements for soldered electrical and electronic assemblies.
IPC standards for medical PCBs can also include regulations applicable to:
- Wire harnesses
- Enclosures
- Cables
Visit the IPC website to learn more about applicable standards.
ISO Standards
The International Organization for Standardization (ISO) develops and publishes a range of standards related to the design, manufacture, and testing of circuit boards.
- ISO 9000 Standard: Mandatory for original equipment manufacturers (OEMs) to certify the safety of medical equipment and its proper function.
- ISO 13485:2016: The international standard for quality management systems for companies that design, manufacture, and service medical devices. The standard focuses on risk management and risk-based decision-making.
FDA Standards
The United States Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) imposes laws on companies that manufacture, re-label, re-package, and import medical devices in and into the U.S.
Operating within the FDA is the Center for Devices and Radiological Health (CDR). This component of the organization monitors electronic products that emit radiation, including X-ray equipment, lasers, ultrasound devices, and others.
The FDA categorizes medical devices into three classes:
- Class I: Includes adhesive bandages, sunglasses, IV (intravenous therapy) stands, and other things considered relatively low risk.
- Class II: Includes intermediate-risk instruments like powered wheelchairs, syringes, surgical masks, and other similar items.
- Class III: Includes many high-risk items that use medical device PCB assemblies, such as heart valves and implantable neuromuscular stimulators. This category is the most stringent and is closely monitored by the agency.
In compliance with these standards, Tier II printed circuit manufacturers must keep detailed records for every component they produce for medical device PCB assemblies. If there is ever an issue in the field with a medical device, the FDA requires traceability to determine whether the defect was due to a faulty component in the circuit or another part of the device. These records must be kept indefinitely.
FDA Compliance Categories for Medical Device Manufacturers
The categories below apply only to medical device manufacturers, not those who manufacture the printed circuit assemblies.
Establishment Registration
Domestic and foreign manufacturers must register with the Food and Drug Administration. This takes place electronically unless the organization issues a waiver. Manufacturers must complete an annual verification of their registration information between October 1 and December 31 of each year. Overseas manufacturers must also appoint a U.S. representative.
Medical Device Listing
Manufacturers must comply with medical device listing requirements, including the following types of businesses:
- Contract manufacturers (CM)
- Contract sterilizers
- Manufacturers
- Manufacturers of components and accessories sold directly to end-users
- Relabelers and repackagers
- Remanufacturers
- Reprocessors of single-use devices
- Specification developers
This applies to United States manufacturers of devices for export only.
Quality System Regulation
Quality system regulation involves defining and meeting requirements related to various aspects of medical devices, including:
- Designing
- Fitting
- Labeling
- Maintaining
- Packaging
- Procurement
- Production
- Storing
Manufacturing facilities are subject to FDA inspections to ensure compliance with their standards.
Labeling requirements
According to the FDA, labeling includes the physical device label, its description, and any additional informational text that is included with the device.
Medical Device Reporting (MDR)
The fundamental rationale behind the Food and Drug Administration’s MDR regulation is to identify significant adverse issues related to medical devices and to monitor them on an ongoing basis. It’s a requirement to notify the organization about anything that may have caused severe problems, injuries, or death. All device malfunctions must also be reported. The goal is to uncover and fix issues as soon as possible.
Premarket Notification 510(k)
This law, the Medical Device User Fee and Modernization Act, allows the FDA to conduct medical device premarket notification 510(k) reviews and charge fees for it. Certain businesses could be eligible for reduced costs. Under this law, a business cannot distribute a device requiring a 510(k) submission until the FDA demonstrates valid equivalence.
Premarket Approval (PMA)
Class III products require premarket approvals because they present a significant risk of illness and injury and cannot be compared directly to less-risky class I and II products. Premarket approval is a highly complicated process that includes submitting clinical data to support any claims about the device.
Medical Device PCB Regulations: The Final Word
Medical device regulations are complex, and the process of receiving FDA approval can take several years. Understanding all aspects of compliance and working with manufacturers knowledgeable in medical device PCB manufacturing will help you avoid circuit design issues and ensure no critical steps are missed in the process.
Tramonto Circuits provides engineering and manufacturing support for prototyping and production. Our diligence and 99% quality ratio ensure the circuits used in your devices meet all applicable standards. Contact our engineers to learn how we can support you.