Our UK Sales Manager for Amplivox, Neil Court, discusses why the 4th edition of the EN 60601-1-2 Standard is important to the medical equipment industry, and why you should care.
On the 1st January 2019, the 4th edition of EN 60601-1-2 came into effect. This means that any new medical electrical product should comply with these EMC standards, yet there are products on the market that don’t meet this requirement.
This 4th edition focuses on the quality, performance, suitability and safety of the electrical products that you use each working day in the medical and occupational health industry. For example, 4th edition products have been thoroughly tested based on the product being used in a ‘professional healthcare facility environment’, a ‘home healthcare environment’ and a ‘special environment’.
It’s not just that. With the increased use of radio frequencies, such as WiFi, 4th edition compliance looks at the effects of this on an electrical device and the implementation of a risk management approach.
Why does it matter?
Since the 3rd Edition, we’ve learnt more about our changing environment, advances in technology, and what the implications are for electrical products. Revising this edition is to improve the products that you use and how accurate they are. Put simply, this edition looks at safety and risk for these products.
Here is where it affects you. There are still some products that where produced before the new regulations came into effect that are available on the market, but it does mean that they potentially will not be as accurate or safe as those that are.
At Amplivox, we design our products to be the very best in class, which is why our products, such as the Otosure and PC850, are 4th edition compliant. We’ve also seen those in the industry condense their product offering down due to this latest edition and expect to see this continuing over the coming year.
We’d advise any of our customers thinking about purchasing new equipment to look at the different options out there and consider which product and company will be ‘future proof’. This will ensure that you can keep doing your job with the best equipment possible that will be supported many years into the future.
If you’d like to know more about our products and how we can help you, please get in touch.