IEC 60601-1-2 and EN 61326-2-6 EMC
Testing for Medical products & equipment
EMC Testing, approvals and compliance for medical products and appliances
IEC 60601-1-2 compliance testing for medical electronic & electrical products.
IEC 60601 is a series of technical standards for the safety and effectiveness of electrical medical equipment. Published by the International Electro-technical Commission. IEC 60601-1-2: 2014, 4th edition (the latest edition of IEC standard) is the standard relating to Medical electrical equipment. IEC 60601, Part 1-2: medical electrical equipment part 1-2 general requirements for basic safety and essential performance collateral standard electromagnetic disturbances requirements and tests.
An Electromagnetic Compatibility or EMC test plan is required prior to the quoting stage. This consists of many factors including, listing any patient coupled ports, intended environment such as professional healthcare facility i.e. a hospital, home health care environment or special environments. It also should contain the immunity test levels and the essential product performance criteria for testing based on a risk analysis.
EMC Bayswater Accredited Medical Equipment Testing Standards
IEC 60601-1-2
EN 61326-2-6
Our compliance Services
EMC compliance 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.
Testing medical devices for the USA and North America
Back in July 2014, the Food and Drug Administration (FDA) recognised IEC 60601-1-2 (the fourth edition) may be used to demonstrate EMC for electrical medical equipment, products and systems. Previously Edition 3 of standard (IEC 60601-1-2: 2007) was recognised by the FDA, but after 2017 the FDA only accepts the fourth edition (2014) of the standard.
EN 61326-1 & EN 61326-2-6
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.
So lets get started! What do you need to include in your test plan?
In Annex G, table G.1 of IEC 60601-1-2 it states the recommended essential test plan requirements. This is not an exhaustive list but the basis of the minimum information prior to engaging the services of a testing facility.
- Name and address of testing facility
- Identification is the product is medical equipment of medical equipment system
- Identify all ports and associated cable and how they are exercised during testing
- List the dimensions and weight of the product or system
- State if the product is to be floor mounted, tabletop or portable.
- Is the product separately earthed if so how?
- List all possible power supply configurations including Voltage and frequency
- Performance criteria for testing both safety and essential with a pass & fail criteria
- Which environment will the product be used in?
- List of all applicable emissions and immunity tests
- List of all emissions limits and also immunity test levels
- List deviations to any of the prescribed test methods
- Provide a detailed product configuration for testing including diagrams
There are many more factors and considerations and usually, your local EMC test lab will be able to assist you further and answer some of your questions. You will be required to purchase a copy and read IEC 60601-2-4.
Useful links and documents
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.