What is the difference between a P2 and N95?

Do you know the difference between a P2 and N95?

All respirators are designed for specific?jobs, tasks, and/or industries. In Australia, the distinction between a P2 and N95 respirator merely comes down to the technical specifications, which can be tied back to regional standards.

An N95 is more of an American-style respirator made to comply with the National Institute for Occupational Safety and Health (NIOSH)?in line with 42 CFR Part 84. This standard governs the stringent filtering efficiency and ensures the accuracy of at least 95% filtration.

The P2 respirator is made in accordance with the Australian/New Zealand Standard AS/NZS 1716:2012?complying with the regulations and standards set for respiratory protective devices. A P2 must adhere to specific testing and certification criteria including filtration efficiency, with an accuracy of at least 94%.

Credit 3M

You can read more about that 3M sheet here, that sheet shows just one example of a P2 not suitable for healthcare.

Both the P2 and N95 are designed to filter airborne particles.

A further breakdown of the two can be seen below.

N95 Respirator (United States Standard):

Filter Performance:

• The N95 respirator?is designed to filter a minimum of 95% of airborne particles, including those as small as 0.3 micrometres.

Fluid Protection:

• By design, an N95 provides a higher level of fluid resistance, making it a suitable option for healthcare environments where exposure to bodily fluids is a concern.

Fit Testing:

• Proper fit is paramount for N95 respirators to provide their full level of intended protection, maximizing both filtration efficiency and fluid protection.

P2 Respirator (Australian/New Zealand Standard):

Filter Performance:

• P2 respirators?are certified to filter out at least 94% of airborne particles, including those measuring 0.3 micrometres or larger.

Fluid Protection in Healthcare:

• While P2 respirators may offer adequate filtration, a P2 typically only has a level 2 fluid rating. In healthcare settings, a higher fluid protection of a level 3 grade is required. To be eligible for the healthcare sector, a P2 respirator must also meet the stringent criteria set by the Therapeutic Goods Administration (TGA).

TGA Approval:

• While?part of the Australian?Government Department of Health,?the TGA plays a pivotal role responsible for regulating therapeutic goods?for a range of products, including respirators. Any respirator intended for healthcare use must undergo stringent TGA approval, ensuring it meets the necessary standards for both filtration and .

Fit Testing:

• Proper fit is paramount for P2 respirators to provide their full level of intended protection, maximizing both filtration efficiency and fluid protection.

TGA Approval Broken Down

Face mask regulation

Non-sterile face masks (including respirators) that are intended, by their manufacturer, to prevent the transmission of diseases between people, or are intended to be used in a healthcare environment, are medical devices (see the Therapeutic Goods (Specified Articles) Instrument 2020- external site). They are regulated by the TGA under the Therapeutic Goods Act 1989- external site. - TGA

Face masks that are not regulated by the TGA

"Face masks which are non-sterile and are not intended by their manufacturer to be used for the prevention of the transmission of diseases between people, are excluded from regulation by the TGA under the Therapeutic Goods (Excluded Goods) Determination 2018." - TGA

Just to be clear, by design, an everyday P2 manufactured for industry (as mentioned above) has not undergone the stringent process required to be deemed a 'medical or surgical respirator" and will not be approved for the healthcare sector.

Let's really break this down.

All P2 masks found in healthcare have to undergo stringent processes to meet approvals and standards and be deemed a 'medical or surgical respirator' labeling them 'hospital or medical grade', and they must again be approved by the TGA to end up in the healthcare sector.

While not specifically mentioned in the ISO 22609 or TGA standards, healthcare-grade masks, including P2 masks, are generally required to meet high standards for Bacterial Filtration Efficiency (BFE) and Particulate Filtration Efficiency (PFE).

This is why the classic 3M 9320A+ particulate respirator was used within the healthcare sector until it was recognised that it did not meet TGA approval.

Safety Data Sheet - 3M? Aura? 9320A+ Particulate Respirator, FFP2

The 3M 1870+ and 3M 1860 particulate respirators, by design, are intended for healthcare. These masks also have the Bacterial Filtration Efficiency (BFE) > 99% according to ASTM F2101and meets CDC guidelines for Mycobacterium tuberculosis exposure control.

Safety Data Sheet - 3M? Aura? Health Care Particulate Respirator and Surgical Mask 1870+, N95 and 3M? Health Care Particulate Respirator and Surgical Mask 1860, N95.

The Softmed A-Med, Industree Trident, Care Essential range, and Detmold masks are all proudly Australian owned P2 respirators that would not be found in hospitals if they did not undergo the above approvals and standards, deeming them healthcare-grade and TGA-approved.

These P2 respirators have successfully reached their target market.

Without such approvals, you would and most likely still will find these in the industrial sector and more likely, in the back of a dirty ute tray.

On the flip side, there are hundreds of P2 masks that will not be found in healthcare.

Common Approvals and Standards N95

• NIOSH approved N95 respirator
• Meets NIOSH 42 CFR 84 N95 requirements for a minimum 95% filtration efficiency against solid and liquid aerosols that do not contain oil.
• NIOSH approval number: TC-84A-0006
• FDA cleared for use as a surgical mask
• Health Canada Class 1 medical device
• Bacterial Filtration Efficiency F2101 >99% BFE
• OSHA Assigned Protection Factor (APF) 10
• Australia TGA approved

Common Approvals and Standards P2

• P2 certified
• ARTG
• Hospital Grade
• AS 4381: 2015 Level 3, 160 mmHg
• AS/NZS 1716: 2012
• Bacterial Filtration Efficiency (BFE) >99%
• BS EN149 FFP2 NR
• AS 4381:2015 Level 3 – ISO 22609

Additional Technical Considerations

Breathability:

• Breathability is a key component considered when designing both the N95 and P2 respirators. The choice of materials and filter media influences assist with meeting effective filtration and breathability for the wearer.

Valve Options:

• Some respirators may feature exhalation valves designed to enhance breathability especially in warmer weather. However, many healthcare facilities have steered away from valved respirators. As a result, you will not see valved respirators within healthcare facilities.

Use in Healthcare Settings:

• N95’s typically have a higher fluid protection factor and are commonly used in healthcare settings across the United States. These respirators have been adopted here in Australia, with an N95 being a common choice in our healthcare sector as well. The Australian P2 respirator is prevalent in various industries and more recently, in healthcare. If a P2 respirator has an intent on infiltrating the healthcare sector, it must meet the elevated level 3 fluid resistance standards having specifications to be TGA approved.

Recap

The P2 and N95 are both designed to provide effective respiratory protection against airborne particles. The country of origin determines the different standards and certifications to which they are designed. Wearers must always follow manufacturer recommendations when being worn and undergo a fit test?to optimise the respirator's full level of intended protection.

If you require additional information, you can contact Fit Test Australia Pty Ltd via email - [email protected].?

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