Medical-grade air purifiers and medical-grade HEPA filters are now everywhere. A google search for medical grade air purifier returns millions of results.
And here’s one company selling what it claims to be a medical-grade air purifier.
But what actually is a medical grade air filter? Let’s find out.
Medical Grade Air Purifier Standards
In the US, the FDA that sets the standards for medical devices. Under the FDA standards, the FDA recommends that air purifiers capture at least 99.99% of the claimed particulates.
In other words, if a medical air purifier is marketed to filter SARS-CoV-2, then the FDA expects that purifier to filter out least 99.99% of SARS-COV-2.
This is important: a medical-grade purifier must be tested against the particle size or pathogen mentioned in the marketing. For example, take an air purifier that captures 99.99% of 1.0 micron particles. The seller can’t advertise it as a medical grade purifier for protection against coronavirus (0.1 microns in size) in this case.
Conclusion: medical-grade air purifiers should capture at least 99.99% of claimed particles
What Kind of HEPA Filter is ‘Medical Grade’?
There are many different classes of HEPA filters. For example a H12 filter captures 99.5% of particles, and a H13 filter captures 99.95% of particles. What class of HEPA filter is medical grade? Many air purifier companies use the wording “H13 medical grade filters.”
But H13 filters only capture 99.95% of 0.3 micron particles, not the 99.99% the FDA recommends. So it’s possible these companies may be falsely advertising their filters as medical grade.
This is complicated. With companies calling their filters medical-grade but nothing to prove it, how can consumers looking to buy an air purifier find a reliable solution?
The Real Way to Find Medical-Grade Air Purifiers
It turns out, the FDA has us covered for this as well, and the answer’s surprisingly simple. The FDA keeps a list of certified medical-grade air purifiers.
A searchable database of all FDA approved medical devices is available for search. The FDA explains “If the manufacturer wishes to label the device for indications to prevent or treat a specific respiratory disease, the device is Class II and requires 510(k)”. (Read their full explanation on medical purifiers here).
If companies aren’t in the FDA list, then they may be falsely advertising their air purifiers as medical-grade. So, be sure to check the list.
Not all Medical Grade Filters HAVE to reach 99.99%
Note how the FDA uses the word “recommends”, when they mention the 99.99% standard. The FDA doesn’t require that purifiers meet this filtration rate. What’s more, they’re pretty up front that their recommendations aren’t legally required.
A filter that captures just 50% of particles could potentially be certified medical-grade. It’s up to the FDA to decide.
How I Protect Myself
Smart Air is a certified B Corp committed to combating the myths big companies use to inflate the price of clean air. Smart Air provides empirically backed, no-nonsense purifiers and masks, that remove the same particles as the big companies for a fraction of the cost. Only corporations benefit when clean air is a luxury.