The new EMC-standard for medical electrical equipment is already in full effect, and by January 2019, the transition period for the old EMC standard is ending.
On 1 January 2019, the old version of the EMC standard for medical electrical equipment will be expiring. There are significant differences between the two versions of the EMC standard, which are worth looking into if you intend to continue selling your products in the EU. All medical devices, whether newly developed or existing devices continuing to be sold, must conform to the new version of the standard, EN 60601-1-2, 4th edition.
When the transition period expires, manufacturers will no longer be allowed to follow the older version of the EMC standard. Therefore, if you are a manufacturer, it is important for you to learn about the differences between the two versions of this standard so you can ensure that your product can continue to be sold legally. In this article, we give you an overview of the things you should pay particular attention to in comparison to the old EMC standard.
Risk management and the Risk Management File
A key requirement for medical equipment is risk management. The equipment must be constructed in such a manner as to minimise the risk of injury or damage to persons or surroundings. Manufacturers who have their equipment CE-marked are responsible for continually analysing and reducing errors in the equipment itself and malfunctions arising from improper equipment usage.
In the 4th edition of the EMC standard for medical electrical equipment, EN 60601-1-2 (2015), risk management dominates. In a separate risk management file it is required to document that appropriate levels of EMC testing have been chosen for the equipment in question, its use, those persons that will be using the equipment, and the environment in which the equipment will be used. Foreseeable misuses of the equipment must also be accounted for.
What is EMC?
Electrical apparatus create electrical and magnetic fields. Electromagnetic compatibility (EMC) refers to specific goals as to how a given electronic product coexists with other products without interference from other products, or itself interfering with other products due to these fields.
