Class I Medical Device PCB
Buyers of home medical devices often ask one question. They ask what to do if the board fails safety rules. Class I medical devices are low-risk equipment. Common examples include blood pressure monitors, thermometers, rehabilitation therapy devices, home oxygen concentrators, and home ventilators. These devices touch home users directly. Board insulation and withstand voltage must have enough margin. Boyastar Electronic Technology Co., Ltd. was founded in 2008.
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Safety for Home Medical Use
Buyers of home medical devices often ask one question. They ask what to do if the board fails safety rules. Class I medical devices are low-risk equipment. Common examples include blood pressure monitors, thermometers, rehabilitation therapy devices, home oxygen concentrators, and home ventilators. These devices touch home users directly. Board insulation and withstand voltage must have enough margin. Boyastar Electronic Technology Co., Ltd. was founded in 2008. We have built PCBs for 18 years. Our factory is in Guangde Economic Development Zone, Anhui, China. The Class I Medical Device PCB service is made for these devices. Medical boards have high certification requirements. We hold IATF16949 automotive quality system certification. We also hold ISO9001, ISO14001, and ISO45001. We hold Underwriters Laboratories product safety certification. The file number is E528398. These approvals help buyers meet North American and European market access rules.
Materials and Safety Review
This board uses FR-4 as the base material. Buyers can also request high TG FR-4 or high CTI FR-4. Layer count ranges from 2 to 20. Surface finishes include immersion gold, HASL, OSP, immersion silver, immersion tin, and hard gold plating. Buyers can request thick copper or impedance control. Safety design, long-life design, and high-reliability design are the three focus points. Buyers send Gerber files. Our engineering team does production review first. They send a formal quote and lead time within 24 hours. The first order quantity can be negotiated. Batch orders start at 500 pieces. One order uses one standard. We do not mix different models on one line. Our engineering team has more than ten engineers. They do safety review and manufacturability analysis. We accept OEM and ODM orders. We build from drawings or prototypes. Layer count, board thickness, copper thickness, base material, surface finish, solder mask color, silkscreen color, safety requirements, and packing can all be adjusted.
Safety Tests and Full Records
Safety failure is the top risk for medical boards. We run withstand voltage tests, insulation tests, and temperature rise tests on every batch. We confirm the first article before mass production. Our quality team has more than 20 people. Every batch gets 100% electrical testing. We use AOI optical inspection and flying probe testing. We accept third-party inspection. We keep records for every step from incoming material to final shipment. Buyers often ask if we do full inspection before packing. We do. Every batch is fully inspected. The Class I Medical Device PCB service gives buyers a safe path for home medical designs.
Specifications Buyers Need to Know
|
Parameter |
Content |
|
Applicable Devices |
Class I low-risk medical devices: blood pressure monitors, thermometers, rehabilitation therapy devices, home oxygen concentrators, home ventilators |
|
Base Material and Layers |
FR-4 / high TG FR-4 / high CTI FR-4; 2 to 20 layers |
|
Surface Finish |
Immersion gold, HASL, OSP, immersion silver, immersion tin, hard gold plating |
|
Special Processes |
Thick copper, impedance control, safety and long-life design |
|
Quality Certifications |
IATF16949, ISO9001, ISO14001, ISO45001; Underwriters Laboratories product safety certification, file number E528398 |
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