What are the coverall standards?  The purpose of the disposable coverall is to protect individuals from the chemical, physical and biological hazards that may be encountered during the handling of hazardous substances.   During the pandemic outbreak, healthcare works are working in situations where unseen pathogens can come from any direction.  Because it typically provides users with 360 degrees of protection,  the coverall can provide a higher-level safety guard comparing with medical gowns.    To keep in mind, the user of protective clothing must be aware that no single protective clothing can protect you from all hazards.  Therefore, protective clothing should be combined with other protective methods. Generally, the higher the level of protective clothing, the greater the associated risk.

So, which coverall should I use, and what are the differences in standards in different countries?

The Standards

The testing requirements for protective clothing are more stringent, and the material of the fabric, sewing, and the whole garment must meet the regulatory standards.   Let us look at the United States Standards first.

United States PPE Ratings

In the United States, there are no specific testing standards for coverall suit itself; however, there are 4 levels of situational standards that must be followed when using PPE.

• Level A – required when you are working in the most hazardous environment and your skin, eyes, and respiratory need extra protection.
• Level B – needed at the highest level of respiratory protection and skin protection need at a lesser level. It is included hazardous in waste sites, vapors, or gas.
• Level C – needed when the concentration and airborne constituents are involved and need air-purifying respirators.
• Level D – need minimum protection and hazards level of work is not included.

Level A

The level A PPE gear is the highest level of protection.   The protection is especially needed for skin, eyes, and mucous membrane.   Level A PPE fights against the following list of environmental conditions:

• vapors
• gases
• particles
• mists
• liquids
• chemical

Level A PPE Requires

• A fully encapsulating chemical entry suit
• A positive pressure (pressure-demand), self-contained breathing apparatus (SCBA) (NIOSH approved), or positive-pressure supplied-air respirator with escape SCBA.
  • The breathing apparatus is encapsulated within the suit.
• A set of chemical-resistant boots with steel toes and shanks on the outside of the suit
• A set of chemical-resistant gloves (both inner and outer layers).
•  A two-way radio is worn inside the suit.  The radio incorporates a microphone and an earpiece speaker.

Level A is the highest level of protection  for skin, eye, and mucous membrane.

Level B

The level B PPE gear is the 2nd highest level of protection.  It should be selected when the highest level of respiratory protection is needed, but a lesser level of the skin and eye protection is needed. It fights against the following list of environmental conditions:

• gases
• particles
• liquids
• chemical

 Since the breathing apparatus is sometimes worn on the outside of the garment, Level B protection is not vapor-protective.

Level B PPE Requires

• A positive pressure (pressure-demand), self-contained breathing apparatus (SCBA) (NIOSH approved), or positive-pressure supplied-air respirator with escape SCBA.
  • Level B suits can also be fully encapsulated which helps prevent the SCBA from becoming contaminated.
• Chemical resistant clothing
  • (overalls and long-sleeved jacket, coveralls, hooded chemical splash suit, disposable chemical-resistant coveralls.)
  • Wrists, ankles, facepiece and hood, and waist are secured to prevent any entry of splashed liquid.
  • The garment itself may be a one-piece or a two-piece hooded suit.
• A set of chemical-resistant gloves (both inner and outer layers).
• A set of chemical-resistant boots with steel toes and shanks on the outside of the garment.
• Two-way radio communications are also required

Level C

Level C protection is selected when the type of airborne substance is known, concentration measured, criteria for using air-purifying respirators met, and skin and eye exposure is unlikely. Periodic monitoring of the air must be performed.  It protects the following environmental conditions:

• particles
• liquids
• chemical

Level C PPE Requires

• Full-face or half-mask, air-purifying respirator (NIOSH approved).
  • No need for SCBA, can use other regular types of respiratory protection
• Chemical resistant clothing
  • (one-piece coverall, hooded two-piece chemical splash suit, chemical resistant hood, and apron, disposable chemical-resistant coveralls)
  • Wrists, ankles, face-piece and hood, and waist are secured to prevent any entry of splashed liquid.
  • The garment itself may be a one-piece or a two-piece hooded suit.
• Crew members should not use this level of protection unless the specific hazardous material is known and its concentration can be measured.
• A set of chemical-resistant gloves (both inner and outer layers).
• A set of chemical-resistant boots with steel toes and shanks on the outside of the garment.
• Level C equipment does not offer the protection needed in an oxygen-deficient atmosphere.

 Since the breathing apparatus is sometimes worn on the outside of the garment, Level B protection is not vapor-protective.

Level D

Level D protection is basically a work uniform. It requires only coveralls and safety shoes/boots.  Another PPE is based upon the situation (types of gloves, etc.).   Level D protection does not protect the crew member from chemical exposure.  Therefore, this level of protection can only be used in situations where a crew member has no possibility of contact with chemicals.

Level D PPE Requires

• gloves
• coveralls
• safety glasses; (Situational)
• face shield; and (Situational)
• chemical-resistant, steel-toe boots or shoes. (Situational)

Level D PPE should not be worn on any site where respiratory or skin hazards exist.

European PPE Ratings

EN ISO 13688 defines the requirements for a coverall.  It specifies general performance requirements for ergonomics, innocuousness, size designation, aging, compatibility, and marking of protective clothing and the information to be supplied by the manufacturer with the protective clothing.  The regulation further specifies the coveralls into 6 types of suits.

• Type 1: Gas Tight Suits (EN 943 part 1)
  • Protects against liquid and gaseous chemicals.  More or less equivalent to US level A.
    • Type 1a:  Self-contained breathing apparatus wore on the inside.
    • Type 1b：Self-contained breathing apparatus worn on the outside.
    • Type 1c：Air supply via a compressed-air hose system.
• Type 2: Non-gas Tight Suits (EN 943 part 1)
  •  Protects against liquid and gaseous chemicals.  More or less equivalent to US level B.
• Type 3: Liquid Tight Suits. (EN 14605)
  • Protects against liquid chemicals for a limited period.
• Type 4: Spray Tight Suits (EN 14605)
  • Protects against liquid chemicals for a limited period.   More or less equivalent to US level C.
• Type 5: Particulate suits (EN ISO 13982-1)
  • Protects against airborne dry particulates for a limited period.
• Type 6: Reduced Spray Tight Suits (EN 13034)
  • Protects against a light spray of liquid chemicals. More or less equivalent to US level D.

Coverall with En14126 certification requires to add a suffix letter “B” agter the wording type.

The Signs and Symbols for PPE
	Type 1 EN 943-1 Gas-tight suits Gas-proof Fully sealed suits, EN 943
	Type 2 EN 943-1 Non-gas-tight suits Limited gas-tightness Prevent dust, liquids, and vapors from penetrating at overpressure EN 943
	TYPE 3 EN 14605 Liquid Jet Suits Liquid-proof protection Suits are approved to withstand compressed fluids e.g. from hoses and nozzles. The suits must have welded seams. Penetration testing has to be conducted according to EN 369 to provide information on protection in relation to individual chemicals,
	TYPE 4 EN 14605 Liquid Jet Suits Splash-proof protection Suits are approved for the saturation of a liquid that can condense on the suit. The suits must have welded seams. Penetration testing has to be conducted according to EN 369 to provide information on protection in relation to individual chemicals, EN 14605 Type 4B protects against biologically contaminated particles EN 14126
	Type 5: EN ISO 13982-1 Particulate Suits Protect against harmful substances EN 13982 Type 5B protects against biologically contaminated particles EN 14126.
	TYPE 6 EN 13034 Reduced Spray Suits Limited splash-proof protection. Protect when there is a risk of splashing on the suit, EN 13034 Type 6B protects against biologically contaminated particles, EN 14126
	EN 14126 Against Biological Hazards Protects against biologically contaminated particles EN 14126
	Category III PPE of complex design intended to protect the user against any risks with very severe consequences. Such risks may cause serious and irreversible harm to the user’s health and the immediate effects of which the user, presumably, cannot identify the insufficient time. High-level risks are, for example: hazardous substances and mixtures environments, where can be observed oxygen deficiency harmful biological elements high-pressure jets drowning ionizing radiation electric shock high-temperature environments (+100 °C) low-temperature environments (– 50 °C or less) harmful noise falling from a height. The compliance process of complex PPE includes Notified body assessment (EC-type examination) and either on-going surveillance through testing or on-going inspection through factory auditing. More information on PPE Directive (EU) 2016/425
	EN 1149-5 Antistatic Electrostatic protection according to EN 1149-5 (with proper earthing). Clothing made to this standard is only accepted in combination with the standard for flame retardant clothing (531 or 11612). This clothing is worn in explosion-hazard environments – if there is a risk of explosion, there is also a risk of fire. This clothing may not be worn in oxygen-enriched environments.  It does not protect against electric shocks (mains voltage).
	Protects against radioactive particle contamination in accordance with EN 1073-2 (not against radioactive radiation).
	EN ISO 11612 Protect Against Flame EN ISO 11612 certified workwear that protects the wearer against heat and fire.

Conclusion

Good coveralls not only comply with the regional regulations but also provides work comfort.   We received many requests trying to ask the definition of coverall standards.  We believe that this article will solve many of your concerns.  Besides the regulations, you should also pay detailed attention to the garment design, fabric materials, and seams designs.  All these factors, combined with reasonable pricing, would make a solid set of PPE that safeguards the needs of the health worker.  Make sure you request the technical data information from your manufacturer!

Medtecs Medical Gowns(Isolation Gown)

AAMI Level 1 SMMS 22gsm Isolation Gown

AAMI Level 2 SMMS 25gsm Isolation Gown

AAMI Level 3 PE Isolation Gown

AAMI Level 4 PP+PE 36gsm Isolation Gown with Tape

AAMI Level 4 PP+PE 63gsm Isolation Gown with Tape

Chemo Gown

Surgical Gown

Reusable Gown

Frequently Asked Questions