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PCB Assemble Medical devices

December 12, 2022

PCB Assemble Medical devices

Suga produces and puts together medical-grade printed circuit boards for an extensive variety of healthcare equipment, including:

  • Devices used for medical imaging
  • Systems designed for medical monitoring
  • Surgical robotics
  • Radiotherapy or radiation treatment

We carry out ongoing testing throughout every stage of production to guarantee the dependability of medical technology circuit boards.

Automated optical inspection (AOI):
AOI takes pictures of the circuit board using either one 2D camera or a pair of 3D cameras. These images are then compared with the design schematic. Any board that does not align with the schematic is forwarded for a manual review.

Solderability test:
This test verifies the sturdiness and reliability of solder connections.

Ionic contamination testing:
This procedure is conducted to identify any ionic residues left behind during the board fabrication and soldering processes.

Peel test:
It assesses the amount of force needed to separate the laminate material from the circuit board.

Micro-sectioning analysis:
This examination is performed to evaluate the board’s overall quality and to identify any hidden internal defects.

Flying probe test:
Moving probes travel between different test points on the board to detect problems such as open circuits, short circuits, and other irregularities.

Time-domain reflectometer (TDR):
TDR impedance testing is crucial for maintaining signal integrity. It also helps locate any breaks or inconsistencies in electrical pathways, including those within connectors.

Our approach to fulfilling your stringent reliability needs with complete traceability is as follows:

Operating in accordance with IPC-6012 Class 2 and Class 3 standards, we manufacture standard, advanced, and micro printed circuit boards with precise accuracy. Our high-tier boards are compliant with UL 94 V-0 flammability specifications. The following documents and certifications are available upon request:

  • Compliance certification
  • Specifications for all materials used
  • Report from the initial product inspection
  • Copy of the reflow soldering temperature profile (provided with the initial sample)
  • Requirements for photographic documentation
  • Adherence to IPC J-STD-001E standards
  • Documentation for every calibrated instrument utilized in production
  • Report from automated optical inspection or manual visual assessment
  • Results from flying probe or in-circuit electrical testing
  • Report on ionic contamination levels and cleanliness

We adhere to the following industry standards, which enable us to produce superior and dependable medical-grade circuit boards for the healthcare and medical technology sectors:

  • IPC 6011: Establishes the performance criteria for Class 1, Class 2, and Class 3 printed circuit boards.
  • IEC 60601-1: Outlines the fundamental safety and performance prerequisites for medical electrical devices.
  • IEC 60601-2: Specifies the electromagnetic compatibility requirements (covering both emission and immunity) for medical circuit boards.
  • ISO 13485:2016: Defines the quality management system standards applicable to medical equipment manufacturing.

Comprehensive Electrical Testing for Medical-Grade PCBs

We do not compromise on quality and adhere to the strict manufacturing standards required for medical circuit boards—this involves continuous testing throughout the production stages, including cross-sectional analysis, automated optical inspection (AOI), BGA X-ray examination, flying probe testing, and other electrical evaluations.

Integrated Fabrication and Assembly Services

Communication gaps between separate fabrication and assembly providers often lead to delivery delays and board defects. A PCB manufacturer that does not manage assembly will not perform design-for-assembly (DFA) reviews to verify that your board can be correctly assembled. Having a single responsible supplier ensures accountability.

How to Obtain a Quote for Medical PCBs

We can conduct DFM/DFA analysis on your behalf and return a detailed report. You may securely submit your files through our website.

To provide an accurate quotation, we need the following details:

  • Design files in Gerber, ODB++, or IPC-2581 format
  • A bill of materials (BOM), if assembly is required
  • Order quantity
  • Required turnaround time

Suga produces medical PCBs and PCBA that are robust, dependable, and resistant to heat.
Begin an online quotation for circuit boards that satisfy your medical-grade specifications.

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