Medical EMC and Electrical Testing

Medical Electrical Devices and Equipment have to comply to the IEC 60601-1 for General Safety and IEC 60601-1-2 for EMC. Apart from that, there are product specific collateral standards that need to be complied to. Recognized by medical device regulators in most markets worldwide, the standard’s current version is IEC 60601 3rd Edition, Am. 1.

Medical device regulators in markets including the US, Europe and Australia require electromagnetic compatibility (EMC) testing to ensure adequate safety and performance of devices for users and patients. Specifically, regulators require EMC testing to determine if a device can perform safely and effectively without causing electromagnetic disturbances in its appropriate operating environment.

In General Safety Testing as per IEC 60601-1 following are the key test parameters:

  • Earth-bond Testing
  • Leakage Measurement including
  • Earth Leakage,
  • Enclosure Leakage and
  • Applied Part or Patient Leakage: Normal Condition
  • Patient Leakage : Single Fault Condition, Supply Open
  • Patient Leakage: Single Fault Condition, Earth Open
  • Patient Leakage F-Type
  • Patient Auxiliary Current: Single Fault, Supply Open
  • Patient Auxiliary Current: Single Fault, Earth Open

and more...

We offer Testing Services as per IEC 60601-1 requirements.

  • EMI / EMC Testing:

We offer testing services for EMC as per IEC 60601-1-2 namely:

  • Electrostatic discharge (ESD) immunity test
  • Electrical fast transient (EFT) immunity test
  • High Energy Surge immunity test
  • Damped Oscillatory waves immunity test
  • Voltage Dips and Interruptions

We can also provide Product Specific Standard testing services Medical Electrical Devices like Baby Warmers, Electrosurgical Cautery, Foetal Doppler, Suction Units, Hospital Furniture, Autoclaves, Beds, OT Lights, OT Tables, Centrifuges, Vital Psylogical monitors, Home healthcare products etc. as per product specific standards.

Across the Globe, IEC 60601 helps ensure the safety of electrical and electronic medical devices. Our expertise in help ensure that your medical devices and products are in compliance with IEC 60601 standards, and ready for export to global markets. We can help you at any stage of your medical device project ensuring the best certification option for your product, your markets, and your business.

Some of our IEC 60601 Medical Safety Testing services include, not limited to CE Marking class I, IIa, IIb and III devices

  • Risk management and integrated quality system (ISO 13485 and/or ISO 14971) assessments
  • Software and usability assessments to support various IEC 60601 clauses

Risk assessment and File Management

We offer impartial third party support in all aspects of consultation, full product safety testing and completion of a Declaration of Conformity (DoC), to Technical File compilation and review.

Compliance to ISO 14971 is a crucial requirement for IEC 60601

Application of risk management to medical devices is a mandatory requirement when demonstrating compliance to the IEC 60601 series of standards. Without this documentation, compliance is not possible; we can assist you with this and provide support and guidance on ISO 14971 risk management including:

  • Bespoke and one-to-one training
  • Documentation and procedure review
  • Production of essential documentation
  • Gap Analysis, remediation & mitigation
  • CE Marking of electrical medical devices

More information about Risk Analysis as per ISO 14971, Click here>>

I 3 CONSULTING experts provide you with guidance through every step of the CE Marking process for medical devices ensuring successful and efficient product launches.

For more information about our IEC 60601 Medical Device Safety Testing services, or to request a quote, contact us today.

INDIA – Bangalore
+ 91 994 591 2081
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+1 630 696 1293
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GERMANY – Bremen
+49 2161 990 8831
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