Designed to provide the wearer with respiratory protection against inhalation of a hazardous atmosphere respirators are designed for the very efficient filtration of airborne particles.
There are many different types and classifications of respirators, which vary depending on the user's facial coverage and the intended hazardous atmosphere.
Commonly known as a filtering facepiece or half mask, respirators are those masks whose edges are designed to form a seal around the user’s nose and mouth. This tight facial fit is the one primary differences between respirators and surgical masks that are not intended to provide respirator protection.
Examples of these type of respirators include:
- United States and Canada: N95
- China: KN95, KP95
- EU: FFP2/FFP3
- Australia: P2/P3
- Brazil: FFP2/FFP3
REQUIREMENTS
The intended use environment and market country dictate the applicable requirements.
Respirators are generally used in commercial environments, with most intended for use in construction and other industrial type jobs that expose workers to dust and small particles. Some respirators are intended for use in a health care setting, when respiratory and fluid resistance is required.
Due to their primary commercial use, respirator regulations are the jurisdiction of the country’s workplace safety agency. Regulations define the legal obligations to ensure that respirators provide the minimum level of protection against intended risks. Specific requirements by classification will be contained within regulation or cited in referenced performance standards.
Evaluation areas include (but not limited to):
- Certification and Approval
- Classification Designations
- Marking and Labeling
- Particle Filtration Efficiency
- Breathing Resistance
- Leakage
- Flammability
COUNTRY-SPECIFIC REGULATIONS
Country |
Classification |
Primary regulation |
Performance standard |
Australia |
P3, P2, P1 |
AS/NZS 1715:2009 |
AS/NZS 1716:2012 |
Brazil |
PFF3, PFF2, PFF1 |
Fundacentro CDU 614.894 |
ABNT/NBR 13698:2011 |
Canada |
N95, N99, N100
R95, R99, R100
P95, P99, P100 |
- |
- |
Surgical N95 |
- |
- |
China |
N90, N95, N100
P90, P95, P100 |
GB/T 18664—2002 |
GB 2626-2019 |
Level l, Level ll, Level lll |
NMPA |
GB 19083-2010 |
EU |
FFP3, FFP2, FFP1 |
(EU) 2016/425
EN 529:2005 |
EN 149:2001+A1:2009 |
United States |
N95, N99, N100
R95, R99, R100
P95, P99, P100 |
OSHA 29 CFR1910.134 |
NIOSH: 42 CFR 84 |
Surgical N95 |
OSHA: 29 CFR 1910.134
FDA: 21 CFR 878.4040 |
NIOSH: 42 CFR 84
ASTM F2100 |
COVID-19 REGULATORY UPDATES & ADVICE
During the COVID-19 pandmic, regulators around the world are updating and reviewing their standard respirator approval processes. A selection of the updates, by country, are listed below.
Australia
Brazil
Canada
EU
United Kingdom
United States
NOTE: information on these links changes frequently due to the fluid situation.
MARKING
United States
The National Institute for Occupational Safety and Health (NIOSH) specifies minimum approval requirements for respiratory protective devices in Title 42 Code of Federal Regulations (CFR) Part 84.
NIOSH approval labels are described in 42CFR84 (§84.33), and the information they provide, and their locations differ depending on the respirator type. These labels are referred to as “entire” or “abbreviated” (§84.33[e]). However, these labels do not identify the approved respirator’s complete configuration of components.
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European Union
Particle filtering half masks complying with the European standard must display a rnage of informaiton on the product itself and on its packaging.
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