EMC Testing for Medical and In-Vitro Diagnostic Devices
Electromagnetic compatibility (EMC) testing is used to demonstrate that a device is immune to radiated electromagnetic signals and signals conducted in wiring, in its environment of use. It also must not influence other equipment by emitting electromagnetic energy. In the case of medical devices it is an Essential Requirement that this immunity and emission control extends over a wide frequency range.
The 4th edition of IEC 60601-1-2 I is the main reference for establishing what constitutes acceptable EMC performance. It is supported by other, more product specific, standards. Risk analysis should be used to design a test programme. Our service includes these assessments and applies them to new developments and legacy devices.
In Europe the requirements for demonstrating compatibility are found in the MDR, IVDR and the EMC Directive. For the USA guidance has been published by the FDA.
All electrical/electronic devices have the potential to generate some form of electromagnetic interference. For this reason, regulatory bodies around the world have placed limits on the levels of emissions these devices can produce. These regulations apply to the increasing variety of point of care diagnostic devices being developed as well as more established electrically driven devices.
Our test and advise service can examine your products from digital thermometers to tele-medicine systems delivering comprehensive reports
Reports from MET include:
- A summary of the testing that was performed to support EMC and the functions and modes which were tested
- Details of the area of compliance demonstrated along with pass/fail criteria used
- Details of the performance of the device during each test
- An identification of and a justification for any of the standard’s allowances that were used
- A description of and justification for any deviations from the specifications of the referenced standard
- The device labelling and evidence of compliance with the reference standard’s labelling specifications
- A detailed description of all changes or modifications that were made to the device in order to pass any of the EMC tests.
Our anechoic chamber can also be used for alarm testing according to IEC 60601-1-8 Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance -- Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Links to Regulations
At your service is a semi-anechoic chamber and a full range of equipment. Our UKAS ISO/IEC 17025 QMS laboratory offers a variety of EMC testing services.
- Radiated emissions
- Conducted emissions
- Radiated immunity
- Conducted immunity
- Electrical fast transients/Burst testing
- Surge testing
- Dips, interruptions and variations
- Electrostatic discharge
Here are just some of the methods and standards we follow during EMC testing.
EN55011: Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics – Limits and methods of measurement.
EN55022: Information technology equipment - Radio disturbance characteristics – Limits and methods of measurement.
EN61000-4-3: Testing and measurement techniques. Radiated, radio-frequency, electromagnetic field immunity test.
EN61000-4-4: Testing and measurement techniques. Electrical fast transient/burst immunity test.
EN61000-4-6: Testing and measurement techniques. Immunity to conducted disturbances, induced by radio-frequency fields.
EN60601-1-2: General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests.
EN61000-4-2: Testing and measurement techniques –electrostatic discharge
EN61000-4-5: Testing and measurement techniques – surge immunity tests
EN61000-4-11: Testing and measurement techniques – voltage dips, short interruptions and voltage variations immunity tests