Medical PCB Guide ISO 13485 Cleanliness Implantable Requirements

Medical Grade PCBs

Healthcare & Medical Grade PCBs | GZHX
πŸ₯ Healthcare & Medtech

Medical Grade PCBs

GZHX manufactures durable, reliable, thermal-resistant medical PCBs with full traceability under IPC-6012 Class 2 and Class 3 standards.

Healthcare & Medical PCB Applications We Serve

GZHX fabricates and assembles medical PCBs for a wide range of medical devices:

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Medical Imaging Devices

High-reliability PCBs for MRI, CT, ultrasound, and X-ray equipment.

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Medical Monitoring Systems

Precision circuits for patient monitors, ECG, EEG, and vital sign tracking.

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Robotic Surgery

Advanced PCB assemblies for surgical robots and minimally invasive systems.

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Radiation Therapy

Radiation-hardened PCBs for linear accelerators and radiotherapy equipment.

Testing Standards We Follow for Medical PCBs

We perform constant testing at each step of the manufacturing process to ensure reliability of the medtech circuit boards.

Automated Optical Inspection (AOI)

AOI captures images of the PCB with either a single 2D camera or two 3D cameras. The captured image is compared with the schematic. If the board does not match the schematic, it is sent to manual inspection.

Solderability Test

Ensures that the solder joints are reliable throughout the board’s lifecycle.

Ionic Contamination Testing

Detects ionic residues resulting from the fabrication and soldering steps that could affect long-term reliability.

Peel Test

Determines the measure of strength required to peel the laminate from the circuit board.

Micro-sectioning Analysis

Inspection carried out to determine the quality of the circuit board and spot internal failures.

Flying Probe Test

Test probes move from test points to other test points and check for opens, shorts, and other issues.

TDR Impedance Measurement

Time-domain reflectometer measurements essential for ensuring signal integrity. Also checks for electrical discontinuities in connectors and paths.

High-Reliability Requirements With Full Traceability

Under IPC-6012 Class 2 and Class 3, we build standard, advanced, and micro boards with high accuracy. Our advanced boards come with UL 94 V-0 flammability standards.

We provide the following documentation and certificates:

βœ“ Certificate of Conformance
βœ“ Material Specifications
βœ“ First Article Inspection Report
βœ“ Reflow Profile Copy (included with first article)
βœ“ Photo Requirements
βœ“ IPC J-STD-001E
βœ“ Record of All Calibrated Tools Used During Manufacturing
βœ“ AOI Report or Visual Inspection Report
βœ“ Flying Probe or In-Circuit Testing Report
βœ“ Ionic Cleanliness Test Report

We follow these standards to build high-quality, reliable medical PCBs:

IPC 6011

Defines performance specification for Class 1, Class 2, and Class 3 PCBs.

IEC 60601-1

General requirements for basic safety and essential performance of medical electrical equipment.

IEC 60601-1-2

Defines electromagnetic requirements (EMI and EMS) of medical PCBs.

ISO 13485:2016

Provides quality management system requirements for medical equipment manufacturers.

DFM/DFA Checks on Every Board

We specialize in DFM and DFA analysis that prevent issues and offer internal quality review systems that guarantee zero-defect boards. We also provide engineering support to verify if your design is set to perform as expected and IPC Class 3 compliant, should you go for this standard.

Need a medical PCB assembly partner with transparent pricing? We offer several options for ordering parts and assembly.

Extensive Electrical Testing for Medical PCBs

We do not bargain on quality and follow the stringent fabrication criteria that medical boards require β€” this means constant testing at each step of the manufacturing process, such as cross-section, AOI, BGA X-ray, flying probe, and other electrical tests.

Fab and Assembly Under One Roof

The miscommunications between separate fabrication and assembly shops will cause delays in deliveries and errors in your board. A PCB manufacturer that doesn’t handle assembly won’t run DFA checks to ensure your board can properly be assembled. One single vendor is accountable.

Get a Quote for Medical PCBs

Let us run DFM/DFA analysis for you and get back to you with a report. You can upload your files securely through our website.

We require the following information to give you a quote:

  • πŸ“„ Gerber, ODB++ or IPC-2581
  • πŸ“‹ BOM (if you require assembly)
  • πŸ”’ Quantity
  • ⏱️ Turn time
Medical PCB Guide ISO 13485 Cleanliness Implantable Requirements

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