Medical Device Air Purifiers

Medical Grade or Non Medical Grade, whats the difference?  

It is easy to get caught up in the argument about which air purifiers have the best air filters for removing airborne nasties. Let's face it, you can get completely flummoxed when trying to work out if the air purifier you are considering purchasing actually uses a Hepa Filter or a 'True' Hepa filter, or even a 'Mega' Hepa filter.

The fact is, the terms True Hepa and Mega Hepa (and many other types to boot) are actually made up names that have appeared over the last few years as manufacturers and retailers try to gain a march on one another by making their devices sound more super duper than the next.

The name True Hepa is commonly used these days to describe a Hepa filter which is an H13 Grade as opposed to some cheaper devices which often only contain E12 Grade filters. E12 is still good, but traps far fewer of the smallest most harmful particles like viruses and bacteria.

Q. So, as long as an air purifier contains a medical grade Hepa filter of H13 or higher, does that qualify it as a Medical Device?

The answer to this question is a resounding NO.

There are a lot of air purifiers advertised as 'medical grade' devices when in actual fact they are definitely not.

The filter grade alone does not qualify the air purifier as a whole. The grade of the filter itself is of course very important - but the only thing that really counts when testing for true medical device status is whether or not the air coming out of the device when it is actually running is of a continuous certifiable medical standard.

What use is a filter that removes 99.99% of pollutants if only 50% of the pollutants are going through it?

Once your air purifier is switched on and the fan starts pulling the dirty air towards it, how do you know that all the air is being sucked through the filter?

Believe it or not, as much as 50% of the air coming out of some regular air purifiers can remain completely unfiltered. Air always takes the path of least resistance, and so if there is the slightest chance of the dirty air sneaking around the sides of the filter as opposed to working its way through, it will take it.

The key to 100% air purification - Airtight seals and a carefully matched airflow.

For an air purifier to be officially certified as a genuine Medical Device, it has to undergo strict, rigorous testing to prove that the air it delivers under normal working conditions continually meets or exceeds medical grade criteria. The main keys to achieving this are to make sure there is an airtight seal around the filter (thus avoiding any unfiltered air by-pass) and secondly to ensure that the air volume of the fan motor is matched to the size and type of filter. It is imperative to match the fan to the filter meticulously to ensure the speed at which the air is pulled through the filter paper (this is called the media velocity) is not too fast and not too slow. If the dirty air is pulled through a filter too quickly much of the harmful pollutants simply penetrate the filter and come straight out the other side and back into the room. Alternatively, if the air is pulled through the filter too slowly many of the pollutants will not even reach the filter at all. So carefully matching the airflow to the filter is absolutely crucial to removing airborne pollutants, particularly when it comes to viruses and bacteria. 

Most mass market air purifier brands do not submit their units for medical device testing because (a) It is very expensive and (b) Their purifiers are unlikely to meet the strict criteria above.

So does a purifier have to be medically certified to be any good?

This does not mean that non-certified air purifiers are not good. Far from it, in fact there are many exceptional air purifiers on the market which although not medically certified, are still more than sufficient for removing most of the airborne pollutants we encounter everyday at home or in the office. Brands like Blueair, Stadler Form and Aeramax are a case in point. These units are pretty much at the very top of the regular market brands and provide purified air which is still more than 99% devoid of pollutants without necessarily being classed officially as medical devices.

Airgle units are fully certified Class 1 Medical devices which use Hepa filters MERV19 Grade. These units break down harmful particles down to 0.003 microns with an efficiency of greater than 99.999%. That's particles 100 times smaller than those captured in standard H13 Hepa filters.

Devices like these are specifically engineered to help with airborne infection control at hospitals, clinics, dental practices, and other health care facilities. The cHEPA filter removes particles including nanoparticles as small as 3nm (0.003µm) with a 99.999% efficiency. Nanoparticles, such as viruses, which can pass through ordinary HEPA filters and may remain airborne almost indefinitely, are captured by the cHEPA filter. Finally, the patented Titanium Pro® photocatalytic oxidation (PCO) module generates hydroxyl radicals to destroy harmful organics.

These units are no longer just the preserve of hospitals, dental labs and doctors surgeries, they are now available in domestic form for use in your home too. Check out the smallest unit in the range the AG300 for a truly brilliant compact machine which is as much at home in your bedroom or living room as it is in a GP Clinic or dental practice.

View the full range here.


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