At a glance
After NIOSH Approved® respirators are on the market, NIOSH conducts post-market conformity evaluations. These evaluations ensure that respirators continue to meet NIOSH requirements.
Overview
NIOSH approves respirators in accordance with 42 Code of Federal Regulations Part 84 (). After approval and once respirators are on the market, NIOSH 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,
- Be correctly labeled, 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.
Find results from post-market evaluations
Brand protection: Registering the NIOSH certification marks
Only respirators evaluated by NIOSH that meet the minimum NIOSH requirements are considered to be NIOSH Approved respirators. However, products exist in the marketplace that are not approved by NIOSH. These products may intentionally or unintentionally mislead end users into thinking they are.
To address this issue, NIOSH 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. Only NIOSH Approved respirators can be labeled with these marks.
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.
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. See the latest version of the fraud and fraudulent statements policy on the NIOSH Conformity Assessment Letter to Manufacturers webpage.
More information can be found on the Counterfeit and Misrepresented Respirators page as well as the Tips to Spot Counterfeit Respirators webpage. To report a potential counterfeit respirator, email PPEConcerns@cdc.gov.
Respirator product audits
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).
Nonconforming Respirator Investigations
A Nonconforming Respirator Investigation (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 Nonconforming Respirator Investigation 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.
Nonconforming Respirator Investigations 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.
Site audits
In addition to product audits and Nonconforming Respirator Investigation, 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.
Escape respirator evaluations
Respirators sampled from mines
As part of the NIOSH Long-Term Field Evaluation program, NIOSH conducts point-of-use assessments by sampling and testing NIOSH Approved Subpart O closed-circuit escape respirators (CCERs, 42 CFR Part 84 Subpart O) and self-contained self-rescuers (SCSRs, 42 CFR Part 84 Subpart H) that are deployed in underground coal mines around the United States.
- NIOSH evaluates CCERs to confirm that the respirators meet the expected performance characteristics of units, such as reliability and life support capabilities.
- NIOSH evaluates SCSRs 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 Respiratory Protection Resources for Mine Workers webpage. Recent point-of-use assessment reports for mining Long-Term Field Evaluations can be found at NIOSH PPE CASE Reports 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 or CCERs, commonly referred to as emergency escape breathing devices by the Navy and commercial shipping industry. Emergency escape breathing devices 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 emergency escape breathing devices can be found on at NIOSH PPE CASE Reports under "Information for U.S. Navy Personnel."
Supporting the NIOSH Fire Fighter Fatality Investigation and Prevention Program
The NIOSH Respirator Approval Program supports the NIOSH Fire Fighter Fatality Investigation and Prevention Program (FFFIPP) by evaluating specific NIOSH Approved self-contained breathing apparatus (SCBA) involved in a firefighter fatality event that may have been a contributing factor.
After NIOSH determines that the SCBA unit can be inspected safely, we conduct tests to determine if the SCBA meets the applicable NIOSH regulations. The Fire Fighter Fatality investigations result in recommendations to prevent future deaths and injuries and may lead to changes in our standard (42 CFR Part 84) or specific National Fire Protection Association (NFPA) standards (e.g., NFPA 1981 or NFPA 1970) that impact how SCBAs are manufactured.
How NIOSH evaluates SCBAs
NIOSH inspects the SCBA to determine if the respirator and its components were assembled and used as approved by NIOSH during the incident. If safe, NIOSH pressurizes and tests the unit, along with assessing and photographing the condition of each major component. If any air remains in the cylinder, NIOSH analyzes a sample.
If NIOSH determines the SCBA to be in a safe condition, staff conduct a series of performance tests to confirm the performance of the SCBA in accordance with 42 CFR Part 84.
Standard test procedures (STPs)
In a typical evaluation, NIOSH conducts the following approval tests:
- Positive Pressure Test [§ 84.70(a)(2)(ii)], STP-0120
- Rated Service Time (duration) [§ 84.95], STP-0121
- Gas Flow Test [§ 84.93], STP-0123
- Exhalation Breathing Resistance Test [§ 84.91(c)], STP-0122
- Static Facepiece Pressure Test [§ 84.91(d)], STP-0122
- Remaining Service Life Indicator Test (alarm) [§ 84.83(f)], STP-0124
These tests generally provide an indication of the SCBA's overall performance. The SCBA's condition or special circumstances surrounding the incident determines the addition or omission of certain performance tests.
For example, NIOSH may perform a special inward leakage test if there is ambient air infiltration into the SCBA facepiece. NIOSH notes performance test failures but will not disassemble the SCBA to determine the cause of any test failure.
Once the evaluation is complete, NIOSH securely stores the SCBA until further instruction from the requestor or a designated authority. NIOSH will maintain all chain of custody documentation per the requestor's requirements, if applicable.
NIOSH provides the evaluation's findings to the requestor in a detailed report and publishes the evaluation reports. The results of testing are part of the public record and NIOSH cannot keep results confidential.
Detailed information about each STP can be found at Air-Supplied Respirator Application Based Fees.
Requesting an evaluation outside of a FFFIPP investigation
To submit an SCBA to NIOSH for evaluation or inquire about submitting an evaluation, please email ppeconcerns@cdc.gov.
NIOSH will provide details to coordinate the shipping of the equipment to the NIOSH facility. Requestors must ship pressurized cylinders as hazardous materials.
Please include a cover letter requesting NIOSH evaluation of the SCBA. Please note on the outside of the package that only the firefighter SCBA lab can open the package.
View completed SCBA investigation reports on the NIOSH PPE CASE Reports webpage.
Other types of PPE
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 firefighter 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. These reports inform respirator users and other members of the PPE community about common themes or trends found and provide best practices recommendations.
- 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.