How much does IEC 60601-1-2 testing cost?

What is IEC 60601-1-2?

IEC 60601 is a series of general standards established to define the safety and essential performance of medical electrical equipment. Under the general standard, there are some collateral standards that require testing based on the specifications of your device. IEC 60601-1-2 is a collateral standard that mandates EMC testing on any electronic medical device. As part of FDA submission documentation, you will need a recognized laboratory to perform IEC 60601-1-2 testing.

This product: Medical Probe

- IEC 60601-1-2 testing cost: The EMC testing cost (IEC 60601-1-2 standard) is $3,800, with a delivery time of 5 weeks. We require 1 sample for testing.

- Note: If this product includes multiple working probes, an additional fee of $500 will be charged for each additional probe.

Please also provide risk management documentation for review.

What types of tests are required for IEC 60601-1-2?

1. Conducted Emissions

- Ensures no emissions are conducted back to the AC power source.

- We must verify that your medical device does not transmit electromagnetic interference (EMI) back to the AC power supply exceeding CISPR 11 limits.

2. Radiated Emissions

- Measures the amount of EMI emitted by the device.

- Most modern electronic devices with microcontrollers produce low-level EMI, radiating into free space. CISPR 11 defines these radiation levels, and we measure your medical device to ensure compliance with the limits.

3. Electrostatic Discharge (ESD)

- Tested with simulated high-voltage ESD equipment.

- Electrostatic Discharge (ESD) is a sudden electrical surge that generates high-voltage sparks. We use handheld devices to simulate these ESD events and test your device to ensure it can handle ESD within the limits of IEC 61000-4-2.

4. RF Immunity

- Injecting RF noise into your device via scans.

- IEC 61000-4-3 involves transmitting various RF signals to the device in a semi-anechoic chamber, while IEC 61000-4-6 involves connecting RF signals directly to your product via cables. These tests ensure your medical device will not malfunction in the presence of other RF signals.

5. Electrical Fast Transient/Burst (EFT/B)

- Evaluates the device’s response to rapid changes in input power.

- IEC 61000-4-4 measures resilience to fast repetitive surges, IEC 61000-4-11 assesses resistance to voltage dips and interruptions, and IEC 61000-4-5 applies constant high-power surges to ensure your device can handle such events.

6. Magnetic Field Immunity

- Tests if your device can handle magnetic fields.

- We simulate high-power magnetic fields and apply them to your medical device as specified in IEC 61000-4-8. These simulations help us evaluate the device's functionality in the presence of magnetic fields.