EMC testing is vital in every application where electronic devices are used, due to the potential disturbances that can be caused by collocated equipment. EMC testing becomes much more important with respect to medical devices, as it can literally be a case of life or death. Any kind of problem with the reliable operation of a medical device may lead to serious consequences. This is why every medical device needs to be tested to comply with the relevant EMC standards.
Why the need for EMC Testing?
When an electric current passes through a medium, it creates a radiated field that emanates from that medium. This radiated field is known as electromagnetic radiation and has the potential to interfere with the operation of other electronic devices. In some cases, EMI can be so severe that it restricts the function of equipment located nearby.
In order to prevent EMI and to ensure the reliable operation of various electronic/electrical components, authorities across the globe have introduced EMC standards. All suppliers wanting to sell products in a particular region need to conform to the EMC standards applicable to that region.
What is EMC Testing?
EMC testing or electromagnetic compatibility testing is the process of evaluating the level of electromagnetic interference generated by various components in a device. This testing is performed to make sure that the device conforms to the appropriate standards.
Once the testing is completed, an EMC test report is issued by the accredited testing laboratory. This EMC test report needs to be kept on record by the manufacturer/supplier to demonstrate electromagnetic compatibility.
EMC Standards for Medical Devices
In Australia medical devices fall under the Jurisdiction of the Therapeutic Goods Administration (TGA). All the devices that fall under TGA jurisdiction must conform to the EMC requirements detailed in the standard IEC 60601-1-2. IEC 60601-1-2 has recently been upgraded to a fourth edition.
Benefits of EMC Testing for Medical Suppliers
One of the main goals of EMC testing in the case of medical devices is risk management. Medical facilities use a wide range of medical devices and these devices could be exposed to electromagnetic interference from other devices nearby. An issue with a medical device could lead to disastrous consequences.
If a medical device has to be sold in Australia, it needs to be included in the Australian Register of Therapeutic Goods. The requirements may change with time but all medical devices are subject to stringent regulations.
EMC testing ensures that a medical device conforms to the required standards. It may also help determine the potential implications of exposure to EMI beyond standard specifications.
EMC Compliance is Mandatory
EMC testing and certification are mandatory for all major economies across the globe. It is especially important in the case of medical devices. If you are a supplier that wishes to introduce a new medical device in Australia or you are an Australian supplier looking to export medical devices to other parts of the world, you need to make sure the device is in compliance with the relevant standards.
EMC Testing Laboratory
Partnering with an experienced and reliable EMC testing laboratory will help you gain valuable insight into the ability of your equipment to operate in the presence of EMI phenomena.
Here at Compliance Engineering, our team takes pride in offering comprehensive EMC testing and certification facilities for a wide range of products, including medical devices. Get in touch with our team to learn more about our services and how we can help you become compliant.