Medical PCB

The development of medical devices is not limited to technology, but also requires a commitment to reliable PCB production, superior functionality and adaptation to stringent medical standards. Accurate PCB prototyping, PCB layout, PCB assembly and most importantly material quality are the primary issues of medical engineering requirements. As medical technology continues to advance, medical PCBs are moving in a higher direction and being utilized in more diagnostic equipment.

LST as an integrated manufacturing solution for leading medical device companies, from PCB assembly and component sourcing, to finished product assembly and testing. We keep up with market trends and introduce advanced technologies to create high-end medical electronics products for our customers.

Product Applications

Standards for Medical PCBA

Medical devices are life-threatening equipment, so we have to ensure the safety of our products throughout the entire process from the beginning of development. Timely detection of potential hazards. In the design and processing must follow these standards:

1. ISO 9000 or 9001: quality and reliability standards that deal with the design, manufacture and testing of electronic products.

2. ISO 13485:This is a quality management system (QMS) standard designed specifically for medical device manufacturers. It specifies requirements for the entire product life cycle, from design and development to production and aftermarket surveillance.

3. IEC 60601:This is a series of international standards covering the safety and effectiveness of medical electrical equipment. Special attention is paid to protection against electric shock, mechanical hazards and radiation.

4. IEC 61010-1:Safety rules for measuring, control and laboratory equipment using electricity.

5. IPC-A-610:This is a standard for the acceptability of electronic assemblies including PCBs. It covers requirements for soldering, cleaning and other aspects of PCB production.

6. FDA 21 CFR Part 820: This regulation from the U.S. U.S. Food and Drug Administration (FDA) outlines quality management system requirements for medical device manufacturers. It covers areas such as design controls, production controls and device labeling.

7. UL 94: This is the flammability standard for materials used in electronic products, including PCBs. It specifies requirements for the resistance of materials to flame and ignition.

8. CFR 820:It is used to verify production and quality control.

PCB Design And Layout

You can outsource your PCB design to us. Our internal engineers can help you create the perfect PCB for your project. We can use different software to meet your PCB design requirements.

Our Abilities

Assembly TypesComponent TypesFiles Required for Quote and Production
SMT Assembly( with AOI inspection);BGA Assembly(with X-Ray inspection);Through-hole Assembly;SMT& Through-hole Mixed Assembly; Kit Assembly● Passives, smallest size 0201(inch)
● Fine-pitch chips to 0.38mm
● BGA (0.2mm pitch), FPGA, LGA, DFN, QFN with X-Ray testing
● Connectors and terminals
● Turnkey PCB Gerber RS-274X, 274D, or PCB Design file
● Turnkey PCB BOM (Bill of Materials, .xls, xlsx)
● Turnkey PCB Pick-N-Place file / XY file (for production only)
Quality InspectionComponents SourcingOrder quantity
● AOI Inspection;
● X-Ray Inspection
● Voltage Test;
● Chip Programming;
● ICT Test; Functional Test
● Turnkey PCB Full turnkey (All components sourced by Yingstar);
● Turnkey PCB Partial turnkey;
● Turnkey PCB Kitted/Consigned
● Turnkey PCB 5pcs to 100,000pcs;
● Turnkey PCB From Prototypes to Mass Production
PCB TypesSolder TypesAssembly Lead Time
Rigid PCB
Metal core PCB;
Flex PCB;
Rigid-Flex PCB
Leaded; Lead-Free(Rohs);
Water soluble solder paste
From 8 hours to 72 hours when parts are ready

What to look for in medical PCB manufacturing

Medical PCB

Medical equipment in use must ensure absolute safety, so in the design and manufacture of the time to consider all aspects. Core components PCB in the design must start from the product function, the overall assessment, to start from the following points of these issues.

• PCB design should start from the device function, comprehensive consideration of electronic components, circuit board size and other issues.

• The layout should be carefully, especially the alignment problem.

• Choose the right components. Components are related to the service life of the equipment, must find high-quality components in line with the equipment.

•  The circuit board printing time to choose lead-free printing.

•  PCB board should be neat and clean, pay attention to cleaning stains residue.

• The assembled circuit boards must be thoroughly inspected and tested to ensure that they meet the required standards of reliability, performance and safety.

• The manufacturer chosen must have relevant production qualifications and experience.

For more information or to get a product quotation, please send us an email and we will contact you as soon as possible
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