Medical equipment EMC Testing
EMC Testing, approvals and Compliance for medical products and appliances
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.