Medical Device EMC Testing | IEC 60601-1-2
What is involved in getting my medical device tested under IEC 60601-1-2?
Your medical device is complete, but now you need EMC testing for submission to the FDA?
Medical device submissions to the FDA under 510(k) or Premarket Approval (PMA) require a comprehensive series of EMC tests that are commonly known as IEC-60601-1-2. These tests ensure that your medical device meets emissions and immunity standards required by the FDA to sell your device.
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 collateral standards you are required to test under depending on your device specifics. IEC-60601-1-2 is a collateral standard requiring that EMC testing is performed on any electronic medical device. As part of your FDA submission, you need an accredited laboratory to conduct the IEC-60601-1-2 testing.
Regulatory Agencies We Conduct IEC-60601-1-2 Testing For
Quick Turn / Low Cost, IEC-60601-1-2 Testing
We understand the cost and complexities in involved in designing, testing, and submitting your medical device. Our experienced EMC engineers are ready to assist you in quickly conducting your testing, helping resolve any issues, and getting your device to market. We work with companies of all sizes, both established medical manufacturers and first-device startups.
Typical IEC-60601-1-2 testing starts at $6999.
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What Types of Tests are Required for IEC-60601-1-2?
Conducted Emissions
Ensuring there are no conducted emissions back to the AC mains
We need to measure that your medical device is not transmitting levels EMI back to the AC mains that are over the CISPR 11 limits.
Radiated Emissions
Measure the amount of EMI Coming Out of Your Device
Most modern electronics with microcontrollers generate low levels of EMI that radiate out into free space; CISPR 11 defines those radiated emissions levels and we measure your medical device to ensure compliance with the limits.
Electrostatic Discharge (ESD) Immunity
Testing Your Device With Simulated high-voltage ESD
Electrostatic discharge (ESD) is the sudden buildup of electricity that can produce sudden high voltage electrical sparks. We use a handheld device to simulate these ESD events, and testing your device to ensure it can handle ESD under the limits of IEC-61000-4-2.
RF Immunity
We sweep and inject RF noise into your device
IEC-61000-4-3 is a test to transmit different RF signals at your device in a semi-anechoic chamber. IEC-61000-4-6 is a similar test, but the RF signals are directly cabled into your product. These tests are conducted to ensure that your medical device will not malfunction in the presence of other RF signals.
Power Bursts, Surges, Dips
How does your device respond to rapid changes to input power
IEC 61000-4-4, is a measurement to evaluate how resilient your product is to rapid repeated bursts of electrical current. As the inverse, IEC 61000-4-11, measures how resilient your product is to rapid dips and shortage of electrical current. Finally, IEC 61000-4-5 applies a constant high-power surge of electricity and ensures your device can handle this event.
Magnetic Field Immunity
Can Your Device Handle Magnetic Fields
We need to simulate high power magnetic fields and apply these to your medical device as stipulated in IEC-61000-4-8. We apply these simulated magnetic fields and evaluate that your device will not function in the presence of magnetic fields.
We Can Have Your Medical Device IEC-60601-1-2 Testing Completed In 3 Weeks
What if my device doesn't pass, can you help us fix it?
Beyond EMC testing, our experienced staff has an extensive background in medical device design and EMC remediation. We can assist in identifying problem areas with your design and implementing cost-effective solutions to get your device back to being re-tested quickly and speed up your time to market
Unlimited Re-testing for Medical Devices
Given how strenuous the testing requirements are for a medical device, we've found that many devices require retesting. As part of our commitment to getting your medical device launched, all of our testing packages come with unlimited re-testing. After you implement our suggestions and produce the updated product, we will re-test your device on the tests it failed in previous testing. If those issues have been fixed, we will re-test the complete product at no additional charge.
Medical Device Testing / IEC 60601-1-2
How is medical device testing from general EMC testing for a consumer product?
In one way medical devices are tested to a similar process as FCC Part 15 Class B device. CISPR 11 measures the radiated emissions of the device and also checks on the AC mains conducted emissions. Where medical device testing becomes much more involved is with the ESD, RF / Magnetic Immunity, and electrical burst / surge / dip testing. These are not typical requirements for an FCC Part 15 device, and many designers face difficulties
What test do you see the most problems with?
Without question, most medical devices have the most problems with IEC-61000-4-2 which is the simulated ESD testing. It is can be very difficult to shunt ESD away from microcontrollers and other sensitive integrated circuits which can cause you to fail this portion of the testing.
How could we pre-test our device?
Many of our clients contact us to conduct pre-testing of their designs. We can assist in a comprehensive pre-test that is 50% the cost of the final testing, and identify any issues in the system at early stage before you have finalized the product enclosures and PCB layouts. While we understand compliance is usually left as a last step, for medical device testing we could encourage you to contact us earlier in the process for pre-testing which we have found is quite valuable for designers.
What standard of IEC 60601-1-2 are you testing to?
We are currently conducting all medical testing to IEC 60601-1-2:2014 Edition 4 which was published February 2014. The FDA currently only recognizes IEC 60601-1-2:2014 Edition 4, so that is what have are testing to
What will I need to provide for testing?
Depending on your device, we will need two samples that are production quality. You'll need to provide us with your finalized power supplies, product manual, and written operating instructions. We'll work in conjunction with your design team to identify if any additional changes are needed in the firmware for testing.
What happens if I don't pass?
Don't worry, over 50% of designs do not pass the first time. The good news is that you choose to work with us. Typically, test labs charge for your time in the lab. If you fail, they don't mind because they are just going to charge you for another re-test. With us there are no additional charges for re-testing your product. Our experienced compliance engineers can provide you with help on what may have gone wrong, and ways to remedy the problem. On a case-by-case basis, we can provide more detailed consulting to assist.
How long should the testing process take for IEC 60601-1-2?
Medical device testing usually can proceed pretty quickly. An IEC 60601-1-2 testing project usually takes around 3 weeks from the time of receiving your device. Unlike a wireless device testing, there are no submissions to an outside certification body, so we can conduct the testing and return you the results quite quickly.