EMI Testing for Heart Device Compliance in the Workplace
- We are involved in every aspect of EMI testing in the workplace to ensure patient/employee comfort and safety.
- Our EMI consulting industry experts involve manufacturers, regulators, and physicians.
- We provide on-site environmental testing and can serve as a resource for the patient’s physician, site surveyor, or employer to determine the level of site evaluation.
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EMI Testing Ensures Compliance with all Compulsory Requirements and Standards in the Workplace
EMI testing ensures people with a pacemaker or defibrillator that there will not be any electrical interference with their vital implanted heart devices in the workplace or your facility. Generally, these devices are meant to operate normally in most work and home environments while using most electrical tools or equipment. While adverse effects are uncommon, there are possible interferences, including:
- Conducted electrical currents
- Radiated electric/magnetic fields
- Static magnetic fields
Most heart devices will operate normally if they are below the established field intensity limits. The standards for limits are established based off input from manufacturers, physicians, and regulators. Patients should always contact their physicians if they feel their devices have exceeded these limits. EMI Field Strengths above what is listed below may cause interference with an undesired device response:
|EMI Source||Field Type||Field Strength Limit|
|High Voltage Power Lines (50/60 Hz)||E-field||6000 V/m peak|
|Continuous Wave or Modulated Magnetic Fields (50/60 Hz)||H-field||80 A/m peak|
|Static Magnetic Field||B-field||5 Gauss peak|
The H-field is useful in ensuring that a time varying magnetic field will not induce electrical voltages or currents in the lead-device-tissue loop area. Any induced electrical signals should be below the device sensing threshold, and well below the capture threshold just as for an E-field.
The B-field limit is useful in ensuring that the device magnet mode (using the GMR, or Giant Magneto Resistive sensor) will not activate. The formal standard is that a device shall not detect environmental fields less than or equal to 10Gauss. The clinical field magnets are much stronger, about 125Gauss at a one-inch distance to ensure properly activating the sensor when desired.
Some commercially available measuring instruments may switch between H units (Amperes/meter or Oersteds) and B units (Gauss and Tesla). Different equipment is needed to measure H- Or B-fields. H-fields require frequency and area to be accounted for. Therefore, different probes will be required to take measurements.
EMI testing in the workplace from Testing Partners will help you achieve compliance the most cost-effective, resourceful and accurate manner possible. Call or fill out our form to find out how we can help.
Why Choose Testing Partners
- Benefit from complete solutions - by utilizing our full range of testing, certification and auditing services
- With a minimum of ten years of expertise in our field.
- We understand testing and compliance regulation.
- Save time and money - by identifying Global compliance considerations at the earliest possible stages of the product development process.
- We help you save money by on time launch. Calculate loss we can help prevent. Click for Late to Market calculator
- On time launch pays for itself.
- Over 90% of products fail compliance the first time.
- We have the knowledge of regulation complexities to launch your product to market.
- Gain a competitive edge - by delivering products of consistent quality and safety, without compromising time to market.