What is EN 14885?

Being a part of the Infection Prevention and Control (IPC) field, EN 14885 has become our holy grail, the one thing we all look to when it comes to bringing a new biocide or chemical disinfectant into the world. In other words, EN 14885 is the guideline for disinfectant efficacy test requirements according to EU regulation. This guideline, with all its 72 pages, detailing the standards and procedures of testing can no doubt be overwhelming, but that is why we are here!

So far, there have been multiple revisions of the EN 14885 published by European Committee for Standardization (CEN) in efforts to constantly update the guideline with new and revised standards to keep up with the continuously growing IPC field. Since the last publication of EN 14885 in 2018, much has happened with the COVID-19 pandemic—which was still happening when the monkeypox virus scare popped up, leading to multiple new and revised standards being released. On July 31, 2022, CEN finally dropped a new revision of the EN 14885 guidelines with more details on how to use the standards in making claims for various products.

How does EN 14885:2022 differ from the old one? Will these changes affect you? We have done a gap analysis and summarized this information so you don’t have to. Keep reading to learn more about this new guideline.

 

What’s new in EN 14885:2022?

In the 2018 version, the standard for efficacy claims of certain product types in certain areas were adopted from other field of application such as the food, industrial, domestic, and institutional areas applied for medical use products or even relied on modified methods. Not anymore! We have summarized the improvements found in the 2022 version in the table below.

 

See a new standard for your product? What should you do now?

“We have tested our medical use surface disinfectant according to EN 13697. Now that there is a new standard EN 17387, what do we do?”—The EN 14885 guidelines thought of everything! The changes we see in the new 2022 revision can fall into two different instances.

One, if the changes in the revised standard have no impact on the test results obtained with the previous version, there is no need to repeat the test and the previous results remain valid for your product claim.

Two, if the changes have an impact on the results or there is a whole new standard published, then your products would have to be tested according to the new standard and/or new revision in order to maintain the claims for your products. Taking our bot question as an example, if your medical use surface disinfectant has been tested according to EN 13697, it would have to be retested with EN 17387. Despite the test method being similar, as laid out in our previous blog post, there are major differences between these two standards including the obligatory test microorganisms, interfering substances used, and the passing criteria which force manufacturers to retest their product to ensure they comply with the new standard.

Most importantly, the new test would have to performed within 18 months after the publication of the new revision which would be January 2024. Not to worry, that is plenty of time to give your products and their claims an upgrade with the new standards. Our experts here at TECOLAB are always available to consult you on what is needed for your products so that it stays in compliance with the new EN 14885 guidelines. Drop us an email and leave the rest to us!