Medical Industry
Medical Industry
What characteristics do medical electronics assemblies need to meet?
High Consistency
The primary requirement for medical PCB Assembly is to provide a reliable signal or output to the same standard when used.
Safety
Some medical devices are wearable or implantable microcircuits on the human body. Protecting the patient from any hazards caused by extreme temperatures or vibrations is essential for medical PCB design.
Convenience
User-friendliness is a major influence in designing a medical PCB Assembly product.
Traceability
Medical Products require strict process records and product traceability, and to some large medical terminals, it requires traceability of PCB Assembly processing records for 10 years.
Which medical devices use PCB and PCB Assembly?
The field of medical equipment is wide, with huge differences in appearance and function, from small-sized and delicate implantable medical equipment to common blood pressure monitors to large-scale nuclear magnetic resonance equipment. These devices are combined with ergonomic design and built-in PCBA, making them suitable for power electronics engineering. The government usually classifies medical equipment by risk level. At the same time, in PCB Assembly manufacturing, classification management is often made according to the complexity of PCB Assembly and the risk level from the government.
Commonly medical monitoring equipment:
– Body temperature monitor
– Blood Glucose Monitor
– Sphygmomanometer
– Heart monitor
– Flow and distribution system
– Electric muscle stimulation device
The complexity of these devices is moderate, the batch is also moderate, and the requirements for stability are high.
Implantable Medical Devices
Implantable medical devices are used to replace any defective organs in the body. It is indeed implanted directly into the patient and as a replacement. The most common devices are pacemakers, artificial kidneys, and cochlear implants.
In addition to stability, this type of equipment has a compact design, small size, long service life, good sealing, and energy saving.
Large diagnostic equipment
– MRI (Magnetic Resonance Imaging):
– CT (Computed Axial Tomography)
– Ultrasound equipment:
What kind of PCBs are needed in medical electronics?
Medical PCBs must guarantee safety and reliability. Life support or high-end products need to meet IPC-3 standards, and non-life support or low-end products need to meet IPC-2. Medical products have a long service life. The general product warranty time is more than five years while. Large medical equipment requires at least ten years of warranty and traceable records. In addition, medical PCBs have a few clearly grades: from multi-layer standard PCBs for entry-level consumer medical products to thick copper PCBs and rigid-flex PCBs that meet conventional requirements on high reliability and high stability used on high High-end diagnostic products, to HDI PCBs and Flexible PCBs hiding in smart, multi-functional wearable, high-density, highly integrated small portable medical products or Implantable Medical Devices.
| PCB Type | Multi Layers | LED | High Frequency | Aluminum | Thick Copper | High Tg | HDI | Flexible | Rigid Flex |
| Medical | x | x | x | x | x | x | x |
Our Medical PCB
Layers: 6 L Thickness: 0.6mm
Out Layer Copper Thickness: 1 OZ
Inner Layer Copper Thickness: 1 OZ
Min Hole Size: 0.2mm Min Line Width: 3mil
Surface Finish: ENIG
Application: Medical X-ray
Layers: 4 L Thickness: 1.6mm
Out Layer Copper Thickness: 1 OZ
Inner Layer Copper Thickness: 1 OZ
Min Hole Size: 0.2mm Min Line Width: 4mil
Surface Finish: ENIG
Application: Medical Equipment
Layers: 4 L Thickness: 1.6mm
Out Layer Copper Thickness: 1 OZ
Inner Layer Copper Thickness: 1 OZ
Min Hole Size: 0.4mm Min Line Width: 5mil
Surface Finish: ENIG
Application: Medical Equipment
What mandatory certifications do medical PCB and PCB Assembly need to meet?
Various medical devices are used in different fields, such as diagnostics, minimally or non-invasive surgery, 24-hour patient monitoring, remote monitoring, clinical research, and more. Therefore, all biomedical devices require specific standards and regulations. Here are some standards and regulations that every PCBA manufacturer should be aware of:
IPC Standards
Formerly known as the Printed Circuit Association (hence the acronym IPC), now known as the Connected Electronics Association. It is an international industry association responsible for publishing a series of circuit board standards. Some important criteria are as follows:
IPC-A-600: This standard covers the acceptability of circuit boards.
IPC-A-6012: It covers the qualification and performance specification of PCBs.
IPC-A-610F: It also covers the acceptability of electronic assemblies. There are different IPC standards for harnesses, welds, enclosures, and cables.
ISO 9000
ISO stands for International Organization for Standardization. Along with the 9000 series, it publishes several standards covering reliability and quality requirements for circuit board design, manufacturing, and testing. OEMs should be certified to one of the ISO 9000 basic safety and essential performance standards for medical devices.
FDA
The US Food and Drug Administration introduced 21CFR820, a quality system regulation. The standard requires medical device OEMs to perform manufacturing and quality control processes without validating subsequent tests or inspections. The regulatory agency confirms that the product meets certain requirements if the OEM has the relevant approvals and certifications.
ISO 13485
It is an important standard for PCB and PCBA manufacturers as it determines the quality management system for equipment in the medical industry. This standard aligns with the ISO 9000 series to specify quality and reliability requirements for medical products. ISO 13485 defines specific standards for circuit board manufacturers to establish a documentation process to track all materials and components used in manufacturing. This is critical for manufacturers of medical devices to understand the recall process for materials and components.
Not all standards require OEMs to be certified to develop medical products. However, these standards and regulations show customers that manufacturers have invested in the necessary systems and are fully focused on PCB assembly guidelines to meet all requirements.
Eashub's experience with medical electronics products
Medical products have high requirements for quality and safety, and it is advisable to select an experienced contract manufacturer (CM) when developing a supplier.
Certification
Eshub’s strategic factory has ISO 13485 certification, EMI 2.0 certification, and ISO9000 certification required for medical device processing, and the products produced meet IPC-2 requirements
Engineering experience
– Miniaturized Surface Mounting Our factory owns high-speed SMT machines that support 01005 sizes component mounting and assist customers in developing assembly kits.
Special Process Capability
– High Power/High Pressure/High Temperature One of our standard process for industrial products
– THT Technology As well as rich THT experience, to meet customers’ experience in building robust medical PCBAs in environments involving vibration or pressure.
– EMI Our strategic factories also meet this standard of EMI2.0, which meets the basic performance and safety requirements of medical equipment in the presence of electromagnetic interference.
– IPC Complaint Bonding Work
– Automated Optical Inspection
– Automatic Conformal Coating
– Aqueous Washing
– PCB with In and Flux-Less Soldering
