Medical-grade air purifier is a common term you often find while you are searching for air purifiers online. By considering the word “Medical grade” all of us are quite into them assuming they cover the most harmful atmospheric pathogens same as hospital air purification.
Can medical-grade air purifiers do better? If so how do other air purifiers differ from normal air purifiers? What are the best suitable places for medical-grade air purifiers?
Talk discuss with today’s Lassowond Know Your Facts. Read and enjoy.
Table of Contents
What Is a Medical-Grade Air Purifier?
A medical-grade air purifier is a device that has grown in popularity during the pandemic season in which the airborne disease Covid-19 has increased.
In addition to standard air purification systems, customers were interested in medical-grade protection, as suggested by the utility’s slogan, “Protect you from medical-grade pathogens.”
According to FDA recommendations, air purifiers must have the following characteristics to be effective against COVID-19.
For the purposes of this guidance, FDA recommends that manufacturers of air purifiers evaluate or perform the following:
1) Demonstration of a 4 log reduction (through a combination of capture or destruction) of claimed particulates.
2) If intended for use against bacteria, effectiveness against representative gram positive and gram negative species.
3) If intended for use related to SARS-CoV-2, effectiveness against a representative virus
4) If the device generates ozone, the maximum acceptable level of ozone per 21 CFR 801.415.
5) If intended for use in areas that have a sterile field or controlled air flow, a risk assessment to address turbulent air flow and/or potential site contamination.
In pandemic season, it has become crucial that medical air purifiers have a higher filtration capacity against SARS-COV-2, per FDA regulations.
In addition, manufacturers cannot label an air purifier as medical grade unless it has been certified to 99.99% filtration protection against particles measuring 1.0 microns.
HEPA & Medical-Grade HEPA Filter
HEPA filters, also known as High Efficiency Performance Air filters, are the greatest alternative for air filtering in technology.
When air purifiers include HEPA filters as part of a combined filtration system, their overall performance is multiplied by several times. There are a variety of HEPA filters with varying filtration capabilities on the market.
True HEPA Filters/ HEPA Filters
These are the most prevalent types of HEPA filters on the market, each with varying filtration capacities. However, some of them are comparable to exaggeration.
For example, HEPA filters are 99.97% effective at catching particles larger than 0.3 microns. True HEPA filters, on the other hand, are identical to these HEPA types with added marketing value.
True HEPA filters, also known as standard HEPA filters, are capable of catching the majority of the microorganisms listed below.
- Pollen
- Dust
- Mold
- Bacteria
- Dust mites
- Common smoke
- Lead dust
- Pet dander
Medical grade HEPA filters are capable of catching tiny particles more effectively than standard HEPA filters.
Medical-Grade HEPA Filters
According to the EN 1822:1998 filter classification, HEPA filters have a variety of configuration possibilities for air purifiers.
| Filter Type | Efficiency % |
|---|---|
| H 10 | 85 |
| H 11 | 95 |
| H 12 | 99.5 |
| H 13 | 99.95 |
In general, medical-grade filters are H13 HEPA filters with 99.9% filtration efficiency for particles larger than 0.1 micrometers.
In addition to HEPA, medical-grade air purifiers are capable of catching the following microorganisms.
- Asbestos
- Paint pigment
- Insecticide
- Anthrax
- Carbon dust
- All bacteria
- Tobacco smoke
- Virus carriers
Average Air Purifier vs Medical-Grade Air Purifier
Here is a brief comparison of two types of air purifiers to facilitate comprehension.
| Parameter | Average Air Purifier | Medical-grade Air Purifier |
|---|---|---|
| Technology | • Three filter configuration • HEPA filter • Activated carbon filter • Air Ionizer • UV lamp/ Ozone generator | • Semiconductor disinfection / purification technology • Built-in double-layer filter • Double-layer semiconductor ionization device • High intensity photocatalytic generator and high power fan |
| Priority Filtration | Particulate Matter 2.5 | Infectious and natural bacteria |
| HEPA Filter | HEPA 0.3 micron with 99.97% efficiency | HEPA H13 0.1 micron with 99.9 % efficiency |
| Recommeds For | Indoor areas | • Laboratories • Hospitals • Medically-approved atmospheric requirements |
How to Identify Medical-Grade Air Purifiers?
The FDA database is one of the greatest methods for determining the quality of medical products.
According to SMARTAIR, the FDA provides a variety of databases to monitor medical grade utilities, and your medical grade air purifier should be included on one of these databases.
1. Establishment Registration & Device Listing
2. 510(k) Premarket Notification Database
3. Premarket Approval (PMA) Database
5. Humanitarian Device Exemption Database
If a product is not included in FDA databases, it is possible that it is falsely marketed as a medical-grade air purifier.
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