The importance of adhering to safety measures in the process of building healthcare and medical related devices cannot be overstated. Ensuring Electromagnetic Compatibility (EMC) is vital for products like Panel PCs and tablet PCs used in the healthcare and medical fields. These types of devices must perform as intended and not interfere with other equipment, or the results could be catastrophic.
IEC 60601-1-2, FCC Regulations, CE Marking and More
EMC testing helps ensure that electronic equipment, like industrial Panel PCs, rugged tablets, HMIs can coexist harmoniously with other devices and systems, preventing disruptions in communication, safety hazards, or malfunctions. IEC 60601-1-2 is an international standard primarily designed for medical electrical equipment and systems. Its focus is on EMC to guarantee the safety and performance specifically for medical devices in healthcare environments.
CE markings are broad conformity marks for products in compliance for EMC sold in the European Economic Area (EEA), while the FCC regulations pertain to electronic devices’ EMC requirements and limits within the United States. Other EMC standards include CISPR Standards for electromagnetic interference and emissions measurements and IEC 61000 Series that addresses EMC for various industries.
What are the Typical Tests for IEC 60601-1-2?
1. Emissions Tests: These tests assess the electromagnetic emissions (unintentional electromagnetic radiation) from the medical device and ensure they are within acceptable limits. Common tests include measuring for radiated electromagnetic interference (EMI) and measuring the conducted emissions on power and signal lines.
2. Immunity Tests: These tests evaluate the ability of the medical device to withstand electromagnetic interference from external sources. Common tests include exposing the device to electromagnetic fields to verify that it continues to operate correctly in the presence of interference ( Radiated Immunity) and injecting disturbances into power and signal lines to assess the device’s immunity to conducted interference (Conducted Immunity)
3. Electrostatic Discharge (ESD) Testing: Verifies the device’s resilience to electrostatic discharge, which can occur when a user touches the device.
5. Voltage Dips, Short Interruptions, and Voltage Variations: Evaluating how the device responds to power supply disturbances, including voltage dips, short interruptions, and variations in voltage levels.
6. Surge Immunity: Assessing the device’s ability to withstand voltage surges that can occur on power lines.
8. Magnetic Field Immunity: Ensuring the device can function properly in the presence of magnetic fields.
9. Power Frequency Magnetic Field Immunity: Verifying the device’s immunity to power frequency magnetic fields.
10. Voltage Ripple and Harmonics: Assessing the device’s response to voltage ripple and harmonics in the power supply.
Our Processes to Ensure Your Product Compliance
1. Component Selection:
Choose components and materials that are designed to minimize electromagnetic emissions and ensure safety compliance.
2. Design and Layout:
Design your device and its PCB layout for Electromagnetic Compatibility. Implement best practices for grounding, shielding, and signal routing.
3. Pre-Compliance Testing:
Conduct pre-compliance testing to identify and address potential issues related to EMI, radio frequency interference (RFI), and safety standards..
4. Emissions Control:
Implement filtering and shielding techniques to reduce conducted and radiated emissions. .
5. Compliance Testing:
Arrange for testing at accredited laboratories for both FCC and CE compliance.
Maintain detailed records of your design, testing, and certification processes.
7. Application for Certification:
Prepare and submit the necessary documentation, test results, for certifications.
And yes, Estone Technology will handle this all for you!
Estone Technology: ODM For Panel PCs and Tablets to meet IEC 60601-1-2, FCC and CE Standards
Partnering with Estone Technology for Panel PC and rugged tablet design and manufacturing can help you feel at ease. Estone Technology keeps product safety in every stage of the product life cycle and makes sure our products pass a performance test, quality assurance test, safety test, and other related regulations for product safety and functionality. Please contact us today to discuss your project.