Post-market Evaluations Conducted by NIOSH
The NIOSH Respirator Approval Program approves respirators in accordance with 42 Code of Federal Regulations Part 84 (42 CFR Part 84). After approval and once respirators are on the market, the NIOSH Respirator Approval Program (RAP) also conducts post-market conformity evaluations—such as product audits—on different types of respirators. These evaluations are done to ensure the respirators continue to be manufactured according to the approval holder’s quality system, perform according to NIOSH standards, and protect the respirator user as intended. Further, NIOSH conducts post-market evaluations for other types of personal protective equipment (PPE) that are worn by workers, such as surgical gowns and gloves, which are briefly summarized below.
As outlined in 42 CFR Part 84.20(B)(5), NIOSH is required to perform respirator product audits to verify the performance of new (unused) commercially available NIOSH Approved® respirators. These audits involve evaluating NIOSH Approved respirators and/or their documentation from every NIOSH approval holder annually. NIOSH product audits include the following quality checks:
- Visual inspections for such things as proper labeling,
- Testing respirators against the NIOSH Standard Respirator Testing Procedures originally performed on the respirator during the approval process. Surgical N95® respirators may also be evaluated for fluid resistance (penetration by synthetic blood) using ASTM F1862, and
- Evaluating the original documentation provided with the NIOSH Approved respirator (for example, the user instructions and full approval label).
If NIOSH identifies any concerns during these quality checks, NIOSH may initiate a Nonconforming Respirator Investigation (NRI).
A NRI (formerly called a Certified Product Investigation Process, or CPIP) is used to investigate a NIOSH Approved® respirator for conformance with the requirements set forth in 42 CFR Part 84 and to address issues ensuring that respirators protect workers as intended. Examples of a nonconformance include:
- Performance or test failure, perhaps identified during a product audit,
- Improper documentation or product labeling, or
- Misleading advertising by the NIOSH approval holder.
Among the goals of initiating a NRI are for NIOSH to document findings of the NIOSH approval holder’s investigation into the root cause of the issue, to review and agree to the approval holder’s planned corrective actions, and to confirm the issues have been resolved for respirators that are in the field or slated for future production. NRIs may result in user notices, stoppage of sales, recalls, retrofits, changes to the NIOSH approval holder’s quality control process or design, or revocation of NIOSH approvals.
A potential nonconformance can also be reported by a respirator user or be self-reported by a NIOSH approval holder. To report a potential nonconformance, email PPEConcerns@cdc.gov.
In addition to product audits and Nonconforming Respirator Investigations, NIOSH conducts site audits of all facilities for current NIOSH approval holders about every two years, even if the approval holder does not currently manufacture respirators. This site audit process ensures that approval holders continue to meet the quality requirements of various parts of 42 CFR Part 84, with the following goals:
- Verify that the approval holder’s quality system is adequate, effective, and operates as described in the documentation on file with NIOSH;
- Safeguard that the manufactured product continues to meet NIOSH performance requirements;
- Inspect the facilities and records as well as interview employees to evaluate the quality system in place.
NIOSH auditors may visit any of the approval holder’s facilities related to maintaining the quality system for approved respirators. The site visits are not limited to manufacturing but also include activities such as design and purchasing. NIOSH conducts approximately 100 site audits each year. More information about the requirements assessed during a site audit can be found in NIOSH CA 2019-1019.
Any issues (known as nonconformances) discovered during a site audit are typically addressed by the approval holder with a corrective action. However, if NIOSH finds serious problems, action up to and including revocation of approval may result.
Respirators sampled from mines
As part of the NIOSH Long-Term Field Evaluation (LTFE) program, NIOSH conducts point-of-use assessments by sampling and testing NIOSH Approved® Subpart O and Subpart H self-contained self-rescuers (SCSRs) that are deployed in underground coal mines around the United States.
- NIOSH evaluates Subpart O mine escape respirators (commonly referred to as a closed-circuit escape respirator [CCER]) to confirm that the respirators meet the expected performance characteristics of units, such as reliability and life support capabilities.
- NIOSH evaluates Subpart H mine escape respirators to ensure life support capabilities are provided over their rated service time.
The results from these evaluations provide useful information on expected respirator performance and assess possible degradation due to the physical stresses of in-mine use. More information can be found on the Resources for Mine Workers webpage. Recent point-of-use assessment reports for mining LTFE evaluations can be found on the NIOSH PPE CASE Reports webpage under “Information for Mine Workers.”
Respirators sampled from ships
NIOSH also supports the U.S. Navy with point-of-use sampling and testing of SCSRs, commonly referred to as emergency escape breathing devices (EEBDs) by the Navy and commercial shipping industry. EEBDs are stored in the event the devices are needed to support escaping a dangerous environment. NIOSH evaluates these devices for their ability to endure the environments in which they are used. The analysis considers storage conditions, physical damage, the effects of aging, and ensures they continue to meet the requirements of 42 CFR Part 84.
Recent point-of-use reports for these EEBD units can be found on the NIOSH PPE CASE Reports webpage under “Information for U.S. Navy Personnel.”
The NIOSH Respirator Approval Program supports the NIOSH Fire Fighter Fatality Investigation and Prevention Program (FFFIPP) by evaluating NIOSH Approved® self-contained breathing apparatus (SCBA) involved in a fire fighter fatal event. These evaluations are done to determine if the SCBA was a contributing factor to the fatality.
After NIOSH determines that the SCBA unit can be inspected safely, it conducts tests to determine if the SCBA meets the applicable NIOSH regulations. Additional testing may be done to determine conformance to requirements in consensus standards, such as those by the National Fire Protection Association. The FFFIPP investigations result in recommendations to prevent future deaths and injuries.
More information can be found on the Support for Firefighter Personal Protective Equipment webpage. SCBA investigation reports can be found on the NIOSH PPE CASE Reports webpage.
NIOSH conducts activities to assess the conformance of various types of PPE—such as gloves, international respiratory protective devices not approved by NIOSH, isolation and surgical gowns, and fire fighter turnout gear—to assess the PPE against relevant performance standards and test methods. These activities help identify gaps in standards or test methods and allow NIOSH to make recommendations to PPE conformity assessment scheme owners, standard development organizations, and other members of the PPE community to protect workers.
Findings of these research activities can be found on the NIOSH PPE CASE Reports webpage, where these reports inform respirator users and other members of the PPE community about common themes or trends found and provide best practices recommendations.
Only respirators evaluated by the NIOSH Respirator Approval Program that meet the minimum NIOSH requirements are considered to be NIOSH Approved respirators. However, products exist in the marketplace that are not NIOSH Approved and may intentionally or unintentionally mislead end users into thinking they are.
To address this issue, the NIOSH Respirator Approval Program has registered certification marks specific to NIOSH Approved respirators. These certification marks are for goods and services related to NIOSH Approved “air-purifying particulate respirators and respiratory protective devices.” Registration of the certification marks provides the U.S. Department of Health and Human Services (HHS) and NIOSH with broader rights and protections under the law. NIOSH controls who can use these marks, and only NIOSH Approved respirators can be labeled with these marks.
As part of this ongoing effort, NIOSH has registered the following certification marks with the U.S. Patent and Trademark Office. See below for registration information for these marks.
Certification Marks Registered in the United States (includes filter classes of NIOSH Approved respirators)
NIOSH is filing additional certification marks with the U.S Patent and Trademark Office corresponding to other respiratory protection levels.
Certification Marks Registered in Other Countries
- The N95 certification mark is registered in Brazil, European Union (EU), Israel, Republic of Korea, Oman, Syrian Arab Republic, Peru, Canada, New Zealand, Colombia, and United Kingdom.
- The NIOSH Approved certification mark is registered in Brazil, Chile, European Union (EU), Israel, Republic of Korea, Oman, Syrian Arab Republic, Colombia, United Kingdom, Canada, Mexico, New Zealand, and India.
See the latest version of the fraud and fraudulent statements policy on the NIOSH Conformity Assessment Letter to Manufacturers webpage.
NIOSH monitors online marketplaces for products that misuse these certification marks and pursues action as necessary to enforce these marks and have product listings removed. More information can be found on the Counterfeit Respirators/Misrepresentation of NIOSH-approval webpage as well as the More Tips to Spot Counterfeit Respirators webpage.
Registration and enforcement of these marks helps ensure that respirator users feel confident when selecting a respirator claiming NIOSH approval that the expected level of protection will be provided. To report a potential counterfeit respirator, email PPEConcerns@cdc.gov.
The NIOSH stylized logos (shown below), N99, N100, R95, P95, P100, PAPR100-N, PAPR100-P, and HE are certification marks of the U.S. Department of Health and Human Services (HHS) registered in the United States.
N95 and NIOSH Approved are certification marks of the U.S. Department of Health and Human Services (HHS) registered in the United States and several international jurisdictions.