Product safety: Electromagnetic Compatibility of electrically operated products
Electromagnetic Compatibility (EMC) is two-folded. The device is expected to function and perform safely without interfering with other devices and systems in the electromagnetic environment in which the manufacturer has intended the device to be used throughout their expected service life.
Secondly, EMC is that the device shall be adequately immune to the electromagnetic phenomena in the environments in which the manufacturer has intended the device to be used throughout their expected service life.
IEC 60601-1-2 is one of the collateral standards within IEC 60601-1 and it concerns electromagnetic disturbances. It is a risk-based standard. Although this standard scope includes medical devices, the requirements are mostly standardized to cover other electrical devices and are universal.
The IEC 60601-1-2 standard is essential for medical device manufacturers. The standard covers an essential part of compliance with the EU MDR and FDA requirements.
Note, that FDA does not recognize the EMC standard for IVD devices, which is IEC 61326-2-6. FDA highlights that the IVD standard confers less expectation of predictability than the FDA-recognized IEC 60601-1-2 standard or provides only part of a complete immunity test for products.
About the IEC 60601-1-2 Standard
The IEC 60601-1-2 standard includes 102 pages and covers, e.g.:
– General requirements: risk management, non-medical equipment, test conditions
– Identification, marking and documents
– Documentation of the tests
– Electromagnetic emission and immunity requirements
The IEC 60601-1-2 standard is a harmonized standard for the Medical Device Directive. It will be harmonized to the Medical Device Regulation ETA in 2024 as EN 60601-1-2.
IEC 60601-1-2 training
Labquality provides IEC 60601-1-2 standard training, which will provide you with essential knowledge about the EMC, the standard and how to use it.
Although this training introduces the EMC phenomenon utilising the medical device standard IEC 60601-1-2, the EMC is a phenomenon related to all electrical devices. The most common EMC requirements for electrically operated products are covered.
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Topics of this session
- Why the standard?
- Relationship of the standard to other standards in IEC 60601-1
- Scope of application of the standard
- Introduction to IEC 60601-1-2
- The future of IEC 60601-1-2 in brief, incl. AMD1: 2020
- IEC 60601-1-2 requirements and tests
- Electromagnetic emission into the public distribution network / environment
- Electromagnetic immunity to the public distribution network / environment
- EMC Plan
- EMC Report
Jouni KarkinenCEO, Karkinen Consulting
Target groupDesigners of the medical electronic devices (electronics, mechanics, radiation, usability, software), regulatory and quality responsible persons, device risk assessment responsible persons.
After this session, you
- You will understand EMC phenomena.
- You will understand the requirements of the standard and how to use it.
- You will be able to combine the standard with other device-specific standards.
- You recognise the risks that the standard requires you to consider.
- You will know how the requirements will soon change.
Billing and cancellation policy
Participation in the training can be cancelled two weeks (14 days) before the event free of charge. For cancellations made after this, we will charge 50% of the participation fee, except for cancellations made one week before the event, we will charge a 100% participation fee.
Cancellations are always made in writing to: firstname.lastname@example.org.
The participating organization may, if it wishes, change the participant free of charge by notifying it in writing before the event to: email@example.com. The participation fee will be invoiced immediately after the event. The training session will be confirmed to the participant by e-mail about a week before the event. Labquality reserves the right to cancel the training session due to a small number of participants.