Standard requirements for medical printed circuit boards

 Medical PCB is a circuit board for medical equipment, which is widely used in medical lighting, ultrasound detection, physiological monitoring and other fields. Electronic components used in medical devices have high safety and reliability standards because they involve human health and medical safety. Therefore, there are many standard requirements in the design and production process of medical PCBs. Let's take a look.

1: Manufacturing requirements

Design and function

Because medical printed circuit boards are used for various devices that need to conform to non-standard sizes, it is very popular to use flexible and rigid flexible circuit boards in the entire medical industry. These circuit boards are made of flexible and lighter weights, which are easier to install in a small space. They are ideal for custom medical equipment. The flexible circuit board compresses the highly complex component into a small space to achieve the best device function without affecting quality.

technology

Printing circuit boards are usually manufactured using surface paste technology (SMT) or electroplating hole technology (PTH). Generally speaking, SMT boards are more widely used because they are easier to install in a small space and provide high-quality results. In addition, SMT reduces assembly costs because technicians do not need to drill on the circuit board.

Material

Materials used in medical device manufacturing are strictly monitored to ensure that each device meets safety requirements. The printed circuit board needs to meet the ROHS standard, and the specific material used usually depends on factors such as heat resistance and connection capacity. Because medical PCBs must be safe when used internally, they are usually applied to FR-4, polyamide, polytrafluoroethylene or ceramic materials as insulation materials. These coatings help transfer heat and prevent damage to the device.

2: Compliance requirements

Several different global and national organizations are responsible for monitoring medical PCBs to ensure standardization and safety in the manufacturing process. The following is a brief overview of several major organizations that monitor the medical circuit board.

IPC regulations

IPC specifications include the assembly of various electronic devices including medical PCBs. PCB standard includes:

IPC-A-600: Overview of acceptable circuit board conditions.

IPC-A-6012: Overview of the performance and qualifications of rigid PCBs.

IPC-A-610: Overview of the acceptability of electronic components.

ISO regulations

International Standardization Organization (ISO) is another management agency that manages PCB design and manufacturing. In addition to design and manufacturing requirements, ISO also provides guidelines for a detailed quality management system.

ISO 9000: Overview of PCB design and assembly quality requirements.

ISO 13485:2016: This is the updated Quality Management System (QMS) for PCB manufacturers.

FDA regulations

The U.S. Food and Drug Administration (FDA) is one of the leading regulatory agencies for medical devices in the United States. The Centre for Equipment and Radiation Health (CDRH) monitors equipment that emits radiation and measures potential risks to nearby individuals. In addition, the FDA classified the device to the patient and the provider's risks based on the device. For equipment manufacturers, FDA requires registration and documentation to include: company registration, equipment list, quality supervision, equipment label, medical equipment report, and pre-market approval.

3: Quality requirements

ISO Quality Management System (QMS) outlines the standards required for medical devices. This standard covers every step of the process, including the required tables and business policies. QMS is built around the DMAIC model.

Definition: Including all stages of equipment overview and proper use of risk management, and defining the equipment life cycle.

Measures: including specifications, data measurement and flow charts.

Analysis: Including analysis data and development solutions.

Improvement: To solve existing problems and predict future problems.

File: Organization and standardization of the recording process.

4: Life requirements

Because medical PCBs have such important functions for patients and diagnostic personnel, they need to continue working for a long time. Even the most sophisticated equipment needs to be replaced.

Make sure that part of the life of the medical PCB is to predict future manufacturing trends and potential obsolete components. If components are no longer manufactured, alternative solutions may be used as alternatives. Unfortunately, the new component may require manufacturers to repeat the approval process before implementing the solution.

5: Access requirements

Medical PCBs should be easy to use and easy to assemble. The connector should be easy to access, and the PCB needs to be unified as much as possible in the height and distribution of the component. To ensure the best fit, the 3D model of creating a circuit board before installing medical equipment is a prudent approach. In this way, you can find potential design problems before manufacturing.

6 maintenance requirements

Before installation, all medical PCBs should be thoroughly cleaned to remove any excess accumulation generated during the manufacturing process. This can ensure that the circuit board is fully functional and does not inhibit the function of the device. We also recommend testing circuits before installation to ensure that the function is normal. If there is any problem, you can debug it before installing the component to the medical device.