Medical equipment EMC Testing

EMC Testing, approvals and Compliance for medical products and appliances

 IEC 60601 is a series of technical standards for the safety and effectiveness of electrical medical equipment. Published by the International Electrotechnical Commission. IEC 60601-1-2: 2007 and IEC 60601-1-2: 2014 are the standards relating to Medical electrical equipment. IEC 60601, Part 1-2: General requirements for basic safety and essential performance. Collateral standard: Electromagnetic compatibility – Requirements and tests.

Medical product EMC compliance testing to EN 61326 and 60601-1-2

Please note that EN 61326-1 and EN 61326-2-6 have been updated. The current versions of the CE mark for Europe can be found in the CE directives. The medical or EMC directive can be used for EMC compliance for European CE marking. To prove CE compliance you may need to check existing compliance evidence. Here is a brief summary of the EN 61326-1 & EN 61326-2-6 changes impact on CE declaration.

EMC testing for medical devices can be more complicated than other products. Additional documentation is usually required. With manufacturer’s input such as providing Risk assessments for deviations in performance. Examples of Risk assessment could be an ESD discharge. Causing a change in an infusion pump to administering drugs. With each discharge resulting in a higher rate than programmed by the medical practitioner. This would be an unacceptable risk to the patient. Whilst if it only caused a momentary flicker on a LED indicator, this may be an acceptable patient risk.

Testing medical devices for Australia

The ACMA’s Electromagnetic Compatibility (EMC) regulatory arrangement imposes an obligation on suppliers. Applying to importers, manufacturers and agents. To ensure that the relevant emissions standards are complied with. Before market delivery. Not all medical devices are subject to the ACMA regulatory arrangement. As they may be regulated by the Therapeutic Goods Administration (TGA). The TGA specifies performance and safety characteristics for these devices. This includes EMC testing of the devices. Medical devices regulated by the TGA are exempt from the ACMA’s EMC requirements. Because they are required to meet the TGA’s EMC requirements. Yet, different compliance testing may be required. An example would be medical devices incorporating other technologies. Such as telecommunications products and radio communications transmitters.

Testing medical devices for the CE mark

As per all CE mark testing, there is a standards framework in place. The official journal of the European Union (OJEU) lists the harmonised standards for medical devices. And can be found here, besides, comprehensive medical device guidelines.

Medical EMC testing at EMC Bayswater

We have had experience with lots of various products including patient coupled automatic infusion pumps (Dosage pumps), skin treatment devices. We have specialised conducted & radiated immunity RF test equipment and many transient testing including ESD. We understand the requirements from the quoting stage all the way through the report stage.

To meet EMC compliance requirements specified by procuring agencies for testing modern complex medical equipment, formal EMC test plans are necessary. EMC Bayswater has performed testing for various medical equipment suppliers with expert knowledge.

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