Get ready for the 4th Edition of EN 60601-1-2 with Eurofins York
As from the 30th December 2018, the 3rd edition of the collateral standard for Medical Electrical (ME) Equipment, IEC / EN 60601-1-2, will be repealed and compliance to 4th Edition of IEC/EN 60601-1-2 will be mandatory for all medical electrical products put on the market thereafter.
As the 30th December 2018 shall be soon upon us, this is the final opportunity for designers, manufacturers and suppliers to ensure that their equipment complies with all the requirements of the 4th Edition.
Any equipment that has been assessed against the requirements of the 3rd Edition, but that has not yet been against the requirements of the 4th Edition, cannot be placed onto the market after the end of December 2018.
This will have a significant impact if you are currently importing, manufacturing or designing equipment and is regardless of whether it was first placed on the market prior to this date.
Now’s the time to act to ensure that you can continue to sell your existing products, as well as ensuring that any new products in development will meet the requirements of the standard.
Eurofins York can help you identify gaps in your product designs against the 4th Edition, and we can provide you with a robust, detailed and effective test plan that will assist you in delivering a compliant product.
All of our laboratories in Grangemouth, Castleford and Bristol are accredited to the 4th Edition and our experienced engineers can work with you to provide you with the actions needed to help you continue to supply existing products as well as helping you ensure that any new products are compliant before they reach the market.
Get in touch now and let us help you achieve compliance.