If you’re investing in personal protective equipment (PPE), you’re doing so because you understand the importance of keeping yourself safe from dangerous environmental factors. Whether it’s a dirty bomb, a chemical attack, or a novel hemorrhagic virus that has swept the world up into a pandemic, you want to protect yourself from it, so you are looking at buying PPE.
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And if you buy PPE, you want to know that it works. This is where PPE certifications and standards come into the equation. Not all PPE is created equal; some PPE is designed for individual tasks. While cold-insulating gloves may do a great job of allowing you to work with metal in a Montana winter, they’ll do a poor job of protecting your body from absorbing the nerve agent VX.
This is why it’s essential to buy quality PPE that suits the task at hand and has received the certifications that allow you to trust your health to their protection.
So, what are the PPE certifications and standards that you need to be aware of if you’re shopping around for gas masks, hazmat suits, and protective gloves? I’m glad you asked.
TABLE OF CONTENTS
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01
NIOSH - The National Institute of Occupational Safety and Health
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02
European Standards
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03
PPE Certification Matters
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04
We Here at MIRA Safety Hit the Mark.
NIOSH - The National Institute of Occupational Safety and Health
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In the United States, NIOSH is the chief determiner of whether PPE can genuinely be classified as trustworthy. If you don’t manufacture a product that NIOSH is happy with, you will not be able to sell your product to the people you want to.
The reason behind this is the Occupational Safety and Health Administration (OSHA). You’ve likely heard this acronym tossed around quite a bit at your workplace. If OSHA isn’t happy, nobody is happy. They possess a wide range of disciplinary powers and can shut a business down if they disapprove of the safety policies and procedures that have been put in place.
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Think of OSHA as the large umbrella corporation that NIOSH falls under. If a business wants to keep OSHA at bay, it will want to use NIOSH-approved equipment. In the event of a workman’s compensation claim, having a history of not using NIOSH-approved respirators, gloves, and gowns is a perfect way for a company to open itself up to some severe litigation costs.
This classification isn’t to say that non-NIOSH PPE doesn’t exist. If anything, 2020 made it more prevalent than ever, as every store you walk into now sells masks and gloves. In this instance, however, the problem is that because this equipment isn’t NIOSH-approved, you have no idea what to expect quality-wise.
That pair of gloves may do what it says it will do. But maybe not. And if a manufacturer isn’t willing to go through the NIOSH certification requirements, there’s an excellent chance that the gloves aren’t what you’re hoping for.
And while NIOSH has a wide range of stringent qualifications for every type of PPE imaginable, we’re going to limit ourselves to discussing the PPE you’re most likely interested in: gas masks, respirators, hazmat suits, and gloves for hazardous materials.
As expected, the testing required to pass NIOSH approval for an essential respirator is rather severe. But if you’re going to make products to help people survive things that are a bit more dangerous than drywall dust, such as nerve agents, chemical weapons, and hemorrhagic fevers, you have to create a product that’s even more robust.
Here are the NIOSH tests you have to pass for a standard CBRN gas mask (without an external air tank) with NIOSH. You’ll see what we mean.
CET-APRS-STP-CBRN-0301
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Determination of CBRN Organic Vapor (Cyclohexane) Service Life Test
CET-APRS-STP-CBRN-0302
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Determination of CBRN Acid Gases (Cyanogen Chloride) Service Life Test
CET-APRS-STP-CBRN-0303
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Determination of CBRN Acid Gases (Hydrogen Cyanide) Service Life Test
CET-APRS-STP-CBRN-0304
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Determination of CBRN Acid Gases (Phosgene) Service Life Test
CET-APRS-STP-CBRN-0305
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Determination of CBRN Acid Gases (Hydrogen Sulfide) Service Life Test
CET-APRS-STP-CBRN-0306
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Determination of CBRN Acid Gases (Sulfur Dioxide) Service Life Test
CET-APRS-STP-CBRN-0307
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Determination of CBRN Base Gases (Ammonia) Service Life Test
CET-APRS-STP-CBRN-0308
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Determination of CBRN Nitrogen Oxide Gases (Nitrogen Dioxide) Service Life Test
CET-APRS-STP-CBRN-0309
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Determination of CBRN Hydride Gases (Phosphine) Service Life Test
CET-APRS-STP-CBRN-0310
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Determination of CBRN Formaldehyde Service Life Test, Air-Purifying Respirators
CET-APRS-STP-CBRN-0311
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Laboratory Durability Conditioning Process for Environmental, Transportation, and Rough Handling Use Conditions on Chemical, Biological, Radiological, and Nuclear (CBRN) Respiratory Protective Devices (RPDs) Standard Conditioning Procedure (SCP)
CET-APRS-STP-CBRN-0312
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Determination of Field of View for Full Facepiece Chemical Biological Radiological Nuclear (CBRN) Respiratory Protective Devices (RPDs)
CET-APRS-STP-CBRN-0313
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Determination of Communication Performance Test for Speech Conveyance and Intelligibility of Chemical, Biological, Radiological, and Nuclear (CBRN) Full Facepiece Air-Purifying Respirator
CET-APRS-STP-CBRN-0314
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Determination of Lens Fogging on Full Facepiece Chemical, Biological, Radiological, Nuclear (CBRN) Air-Purifying Respirator
CET-APRS-STP-CBRN-0316
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Determination of Haze, Luminous-Transmittance, and Abrasion-Resistance Properties of the Primary Lens System Material for Full Facepiece Respiratory Protective Devices (RPDs)
RCT-CBRN-APR-STP-0350
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Determination of Full Facepiece, Tight-Fitting, Negative-Pressure, Air-Purifying Respirator (APR) Performance During Dynamic Testing Against the Chemical Agent Vapor Sarin (GB)
RCT-CBRN-APR-STP-0351
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Determination of Full Facepiece, Tight-Fitting, Negative-Pressure, Air-Purifying Respirator (APR) Performance During Dynamic Testing Against Chemical Agent Distilled Sulfur Mustard (HD) Vapor and Liquid CBRN
RCT-CBRN-APR-STP-0352
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Determination of Laboratory Respirator Protection Level (LRPL) Values for CBRN Self-Contained Breathing Apparatus (SCBA) Facepieces or CBRN Air-Purifying Respirator (APR
CET-APRS-STP-CBRN-0401
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Determination of CBRN Organic Vapor (Cyclohexane) Service Life Test, Air-Purifying Escape Respirators
CET-APRS-STP-CBRN-0402
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Determination of CBRN Acid Gases (Cyanogen Chloride) Service Life Test, Air-Purifying Escape Respirators
CET-APRS-STP-CBRN-0403
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Determination of CBRN Acid Gases (Hydrogen Cyanide) Service Life Test, Air-Purifying Escape Respirators
CET-APRS-STP-CBRN-0404
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Determination of CBRN Acid Gases (Phosgene) Service Life Test, Air-Purifying Escape Respirators
CET-APRS-STP-CBRN-0405
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Determination of CBRN Acid Gases (Hydrogen Sulfide) Service Life Test, Air-Purifying Escape Respirators
CET-APRS-STP-CBRN-0406
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Determination of CBRN Acid Gases (Sulfur Dioxide) Service Life Test, Air-Purifying Escape Respirators
CET-APRS-STP-CBRN-0407
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Determination of CBRN Base Gases (Ammonia) Service Life Test, Air-Purifying Escape Respirators
CET-APRS-STP-CBRN-0408
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Determination of CBRN Nitrogen Oxide Gases (Nitrogen Dioxide) Service Life Test, Air-Purifying Escape Respirators
CET-APRS-STP-CBRN-0409
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Determination of CBRN Hydride Gases (Phosphine) Service Life Test, Air-Purifying Escape Respirators
CET-APRS-STP-CBRN-0410
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Determination of CBRN Formaldehyde Service Life Test, Air-Purifying Escape Respirators
CET-APRS-STP-CBRN-0411
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Laboratory Durability Conditioning Process for Environmental, Transportation, and Rough Handling Use Conditions on Chemical, Biological, Radiological, and Nuclear (CBRN)(Air-Purifying or Self-Contained) Escape Respirator
TEB-APR-STP-0417-CBRN
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Determination of Flammability and Heat Resistance, CBRN Air-Purifying Escape Respirators
CET-APRS-STP-CBRN-0450
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Determination of Chemical Agent Permeation and Penetration Resistance Performance Against Sarin (GB) Vapor of Chemical, Biological, Radiological, and Nuclear (CBRN) Air-Purifying Escape Respirator
CET-APRS-STP-CBRN-0451
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Determination of Chemical Agent Permeation and Penetration Resistance Performance Against Sulfur Mustard (HD) Liquid And Vapor of The Chemical, Biological, Radiological, And Nuclear (CBRN) Air-Purifying Escape Respirator
CET-APRS-STP-CBRN-0452
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Determination of Laboratory Respirator Protection Level (LRPL) Values for CBRN Air-Purifying Escape Respirator (APER)
CET-APRS-STP-CBRN-0454
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Determination of Human Subject Breathing Gas (HSBG) Concentrations (Carbon Dioxide and Oxygen) for Chemical, Biological, Radiological, and Nuclear (CBRN) Air-Purifying Escape Respirator
CET-APRS-STP-CBRN-0456
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Determination of Practical Performance Level for Chemical, Biological, Radiological, and Nuclear (CBRN) (Air-Purifying or Self-Contained) Escape Respirator
CET-APRS-STP-CBRN-0499
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Determination of Donning Effectiveness of Chemical, Biological, Radiological, and Nuclear (CBRN) (Air-Purifying or Self-Contained) Escape Respirator
TEB-CBRN-STP-0501
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Determination of CBRN Organic Vapor (Cyclohexane) Service Life Test, Tight-Fitting Powered Air-Purifying Respirators (PAPR)
TEB-CBRN-STP-0502
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Determination of CBRN Acid Gases (Cyanogen Chloride) Service Life Test, Tight-Fitting Powered Air-Purifying Respirators (PAPR)
TEB-CBRN-STP-0503
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Determination of CBRN Acid Gases (Hydrogen Cyanide) Service Life Test, Tight-Fitting Powered Air-Purifying Respirators (PAPR)
TEB-CBRN-STP-0504
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Determination of CBRN Acid Gases (Phosgene) Service Life Test, Tight-Fitting Powered Air-Purifying Respirators (PAPR)
TEB-CBRN-STP-0505
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Determination of CBRN Acid Gases (Hydrogen Sulfide) Service Life Test, Tight-Fitting Powered Air-Purifying Respirators (PAPR)
TEB-CBRN-STP-0506
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Determination of CBRN Acid Gases (Sulfur Dioxide) Service Life Test, Tight-Fitting Powered Air-Purifying Respirators (PAPR)
TEB-CBRN-STP-0507
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Determination of CBRN Base Gases (Ammonia) Service Life Test, Tight-Fitting Powered Air-Purifying Respirators (PAPR)
TEB-CBRN-STP-0508
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Determination of CBRN Nitrogen Oxide Gases (Nitrogen Dioxide) Service-Life Test, Tight-Fitting Powered Air-Purifying Respirators (PAPR)
TEB-CBRN-STP-0509
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Determination of CBRN Hydride Gases (Phosphine) Service Life Test, Tight-Fitting Powered Air-Purifying Respirators (PAPR)
TEB-CBRN-STP-0510
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Determination of CBRN Formaldehyde Service Life Test, Tight-Fitting Powered Air-Purifying Respirators (PAPR)
TEB-APR-STP-0511-CBRN
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Determination of CBRN Organic Vapor (Cyclohexane) Service Life Test, Loose-Fitting Powered Air-Purifying Respirators (PAPR)
TEB-APR-STP-0512-CBRN
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Determination of CBRN Acid Gases (Cyanogen Chloride) Service Life Test, Loose-Fitting Powered Air-Purifying Respirators (PAPR)
TEB-APR-STP-0513-CBRN
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Determination of CBRN Acid Gases (Hydrogen Cyanide) Service Life Test, Loose-Fitting Powered Air-Purifying Respirators (PAPR)
TEB-APR-STP-0514-CBRN
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Determination of CBRN Acid Gases (Phosgene) Service Life Test, Loose-Fitting Powered Air-Purifying Respirators (PAPR)
TEB-APR-STP-0515-CBRN
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Determination of CBRN Acid Gases (Hydrogen Sulfide) Service Life Test, Loose-Fitting Powered Air-Purifying Respirators (PAPR)
TEB-APR-STP-0516-CBRN
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Determination of CBRN Acid Gases (Sulfur Dioxide) Service Life Test, Loose-Fitting Powered Air-Purifying Respirators (PAPR)
TEB-APR-STP-0517-CBRN
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Determination of CBRN Base Gases (Ammonia) Service Life Test, Loose-Fitting Powered Air-Purifying Respirators (PAPR)
TEB-APR-STP-0518-CBRN
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Determination of CBRN Nitrogen Oxide Gases (Nitrogen Dioxide) Service Life Test, Loose-Fitting Powered Air-Purifying Respirators (PAPR)
TEB-APR-STP-0519-CBRN
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Determination of CBRN Hydride Gases (Phosphine) Service Life Test, Loose-Fitting Powered Air-Purifying Respirators (PAPR)
TEB-APR-STP-0520-CBRN
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Determination of CBRN Formaldehyde Service Life Test, Loose-Fitting Powered Air-Purifying Respirators (PAPR)
NPPTL-STP-CBRN-PAPR-0550
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Determination of CBRN Powered Air-Purifying Respirator (PAPR) Performance During Dynamic Testing Against the Chemical Agent Vapor Sarin (GB) Chemical Biological, Radiological, and Nuclear (CBRN) Standard Testing Procedure (STP)
NPPTL-STP-CBRN-PAPR-0551
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Determination of CBRN, Powered Air-Purifying Respirator (PAPR) Performance During Dynamic Testing Against Chemical Agent Distilled Sulfur Mustard (HD) Vapor and Distilled Sulfur Mustard (HD) Liquid Chemical, Biological, Radiological, and Nuclear (CBRN) Standard Testing Procedure (STP)
NPPTL-STP-CBRN-PAPR-0552
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Determination of Laboratory Respirator Protection Level (LRPL) Values for CBRN Tight-Fitting Powered Air-Purifying Respirator (PAPR)
NPPTL-STP-CBRN-PAPR-0553
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Determination of Laboratory Respiratory Protection Level (LRPL) Values for CBRN Loose-Fitting Powered Air-Purifying Respirator (PAPR)
The total cost for all of these tests is right around $122,000. That’s in addition to the other annual fees and site visits (which can cost up to $10,000) that NIOSH requires to keep your paperwork on file.
As you can see, NIOSH requires a relatively exhaustive list of testing procedures for CBRN gear.
But NIOSH is easy. And MIRA Safety doesn’t take the easy way out.
European Standards
Regulations and laws are stricter in Europe than anywhere in America, and this same principle applies to CBRN equipment. We at MIRA Safety knew that we wanted to sell to the American market, but we wanted to sell to the European market as well. To do that, you must pass European Standards, often abbreviated to ‘EN’ from the German words for “European Norm.”
This is what we did here at MIRA Safety. For example, you can see that our NBC-77 filters passed EN 14387:2004 + A1:2008 and EN 148-1. Because of the massive swath of testing these two regulations require, we can confidently say that this filter will protect you from nerve agents, radioactive particles, toxic chemicals, viruses, and more. (You can see an exhaustive list here under the “NBC-77 SOF Gas Mask Filter Application” subheading. The list is too massive to include here.)
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By getting our gear up to EN standards, we passed the NIOSH bar and opened the door to selling the best CBRN equipment ever made to others at risk of CBRN threats. This decision allowed us to help prepare more people for an uncertain future while simultaneously proving that we were making the most trustworthy gear on the market.
EN standards are incredibly complex, but we have managed to navigate them all.
For example, the PPE regulation for the EN is PPE Regulation 2016/425. According to this regulation, all respiratory protective equipment requires both a CE and a UKCA mark to sell to the entire European market. RPE is also classified as a category III PPE, meaning that the manufacturer must also have an EU Type Examination.
And then, in 2020, things changed drastically
On March 13, 2020, the European Union issued Recommendation (EU) 2021/1433 for PPE, which gave a different list of standards that PPE manufacturers needed to be aware of. This was later repealed when Recommendation 2020/1433 came into play in 2021. This new recommendation makes it so that many products manufactured during the year 2020 can no longer be sold.
Want to make PPE gloves such as our HAZ-GLOVES for sale in Europe?
Then you have to pass EN ISO 21420:2020, EN ISO 374-1:2016, EN 374-2:2003, and EN 374-3:2003. (Sometimes, you may have to pass even more EN regulations.) Want your gloves to protect against radiation? Then you need also to pass EN 421:2010. Protective clothing must pass EN 1149-5.
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And CBRN respirators? Well, respirators are in a world of their own.
So, as you can see, staying abreast of the legal framework of selling any type of PPE is akin to trying to take hold of water.
PPE Certification Matters
It’s not just that you have to make NIOSH and EN happy if you make the most trustworthy PPE to help people survive nuclear war, accidental chemical releases, or pandemic influenza. You often have to make third parties happy as well. A number of the big standardization agencies require third-party certification marks as a prerequisite to getting the official seal from the government agency itself.
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Please consider this another layer in the verification process to ensure that the PPE does what it says it will do. This dramatically eliminates the possibility of corruption and bribery, allowing a PPE manufacturer to get undeserved approval for their product simply because they bought a new vacation home for the tester at, say, NIOSH.
In turn, this helps to protect lives. If soldiers use your product (as they do the CM-7M) to survive a chemical weapon attack, they need to be 100% certain that the respirator and PAPR systems
Image courtesy of (Image courtesy of The MIRA Safety PAPR system.)
For example, this is part of the requirements for NIOSH approval: you have to get a third-party certification. That’s easier said than done.
Respirator manufacturers must first tell NIOSH that they want to seek NIOSH approval by filling out a Manufacturer’s Questionnaire. This in and of itself can be a lengthy process, and NIOSH then assigns a 3-letter manufacturer code that allows the manufacturer to submit a formal respirator approval request. In other words, you must get approval to get an approval request form.
After you get that code, you can fill out another form with all the appropriate test samples, documentation, and fees attached. If you don’t have that, it’s back to the drawing board at the back of the line.
The CSA Group Mark
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The Canadian Standards Association (CSA) manufactures this mark. Several regulatory agencies accept CSA marks throughout the world.
The UL Mark
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One of the most straightforward means of getting PPE certified with a third party is getting a UL mark. Starting in America in 1894, Underwriters Laboratories (UL) quickly became one of the most respected marks out there that a piece of PPE could have on it.
Regardless of which market is your product’s end goal, UL can test to the appropriate country’s standards. Both EN and ISO standards are a part of this.
The Recognized Component Mark
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UL runs this mark. Sometimes products are created that aren’t the end product for the consumer market. For example, somebody may manufacture a gas mask, but they get a critical piece (such as the NATO threads) to their gas masks from another company.
Perhaps the parent company doesn’t have the machinery to manufacture NATO threads. Whatever the reason doesn’t matter. What matters is that the secondary company that makes the threads still needs to produce a product that is good for the final UL-approved product.
This is where the Recognized Component Mark comes into play. The component can be sent to UL for testing, and if it passes the UL testing process, it will be granted a Recognized Component Mark.
The BSI Benchmark
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The British Standards Institution (BSI) – the world’s first international standards company - runs one of the predominant marks from third-party testing/certification companies. The Benchmark requires quite a bit of work to be granted.
The PPE manufacturer must first pass all the various BSI tests before moving forward. If, and only if, the PPE can pass through this colossal battery of tests to ensure that it keeps people safe, then BSI will send a representative to visit the manufacturer in person to inspect the factory that makes all of the PPE. Suppose the BSI representative believes that the factory’s equipment, policies, and procedures can consistently create trustworthy products up to BSI’s standards. In that case, the manufacturer will be granted the BSI Benchmark.
This mark also allows one to sell PPE to Australia and New Zealand.
The Kitemark
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Created in 1903 and run by BSI, the Kitemark can be used to allow one to gain access to the European Union. When this mark started, it was only used in Europe, but now, it can be found as a marker of a high-quality goods worldwide.
One of the reasons that a manufacturer may want to consider getting a Kitemark for their product is because the European market, in particular, considers this a huge indicator of quality. When forced to choose between two comparable products, Europeans know the Kitemark and are likelier to select the product with it. One study found that 49% of Europeans actively look for the Kitemark when they shop.
The CE Mark
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One of the more popular certification marks you’ll see on PPE gear is ‘CE.’ This stands for “conformité européenne,” the French word for “European conformity.” This is the mark necessary to sell PPE within Europe, stating that the gear has met the directives and regulations of the European Union.
A NOTE OF INTEREST
It is worth mentioning that China has saturated the world market with fake CE marks. The official CE mark has a large amount of spacing between the two letters, and in contrast, the counterfeit Chinese CE mark squishes the two letters close together. The unsavvy shopper may be unable to tell the difference, which could easily lead to a lethal problem in situations involving dangerous chemicals.
Fake CE mark Image courtesy of (Image courtesy of Wikimedia Commons.)
The reason is that the fake Chinese symbol doesn’t have any degree of testing behind it. You could buy a Halloween costume, and China could slap a phony CE mark on there and then advertise the product as a piece of PPE that will keep you safe.
When purchasing any protective equipment, you will want to avoid China and its lack of safety standards like a plague.
If found faking a CE symbol, you’ll be ordered to take your product off the market. If you fail to comply, fines and imprisonment may occur. One of the many reasons these Chinese products continue to circulate is the difficulties with extradition.
The CE mark system is reasonably straightforward. Provided you have an official CE marking on your PPE product, you can officially sell anywhere in Europe without needing to get any other certifications or pass any further tests. Well, at the moment, anyway. The United Kingdom has recently decided to change that.
The UKCA Mark
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This is the main third-party mark in development for the United Kingdom. As of January 2023, PPE will only be able to be sold within the United Kingdom with the UKCA mark. While other third-party marks have always sufficed within the UK in the past, this new mark will soon deem all different patterns to be inadequate for what the UK requires while resulting in a massive influx of tax income for the United Kingdom.
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One of the catches here, however, is that the UKCA mark will only work in the UK. If somebody wanted to sell PPE gear to the European Union, they would still have to have the mandatory CE mark. They couldn’t just get the UKCA mark and then be good to go. This adds an extra-legal hurdle for PPE manufacturers. You’ll have to go through two costly legal processes to gain full access to the European market.
We Here at MIRA Safety Hit the Mark
The ultimate point we’re trying to make here is that bringing high-quality, trustworthy, and affordable PPE to the market is complicated, and those who do so have to prove beyond a shadow of a doubt that the gear they create works.
There’s a reason that the US Department of Defense uses our gear, the Czech Republic’s Ministry of Defense, and the Ministry of Interior of numerous other countries. It’s because when you strap on a MIRA Safety gas mask and filter, you know that you will be protected. The certifications and testing are behind the tools you use to protect your family.
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In other words, you can use your MIRA Safety gear in confidence. And we can sell it with complete confidence as well.