NPPTL Respirator Assessments to Support the COVID-19 Response

Updated October 29, 2020

NIOSH/NPPTL has received several requests to assess respirators in the following categories: (1) respirators that are beyond shelf life/stockpiled; (2) respirators entering the United States from a foreign country claiming to meet a non-NIOSH standard; (3) respirators that are going through decontamination methods; and (4) innovative respirator designs or non-NIOSH approved respirators made by commercial equipment. Guidance has been posted regarding use of respiratory protective devices and these situations.

NPPTL has also received several requests from entities who possess filter penetration test equipment. The requests are seeking NIOSH permission to conduct filtration efficiency testing. NIOSH uses Standard Test Procedure TEB-APR-STP-0059pdf icon to confirm filter efficiency (greater than or equal to 95% efficiency) of N95 filters. Entities that have the proper test equipment to conduct this test are free to do so without permission from NIOSH. The results of such tests are for the sample tested and may or may not be representative of a larger lot or population of similar respirators. It needs to be understood that product test results meeting the requirements of a single STP, TEB-APR-STP-0059pdf icon, does not imply the respirator is NIOSH approved. There are many other requirements that must be met to achieve a NIOSH approval. The results of any filter penetration test can only be used to provide a check of the product’s filter efficiency. No conclusions can be made regarding equivalency to N95 products that are NIOSH approved.

For those entities that do not have filter penetration test equipment available, NPPTL will be issuing guidance to have products sent to our laboratories in Pittsburgh, PA and Morgantown, WV to perform an assessment. Separate guidance will be provided for each category: (1) respirators that are beyond shelf life/stockpiled; (2) respirators entering the United States from a foreign country claiming to meet a non-NIOSH standard; (3) respirators that are going through decontamination methods; and (4) innovative respirator designs or non-NIOSH approved respirators made by commercial equipment.

Results reported will only provide a check of the filter efficiency level of the respirator or filter being assessed and cannot be used to make any claims regarding equivalency to NIOSH approved N95 filters or filtering facepiece respirators. Additionally, results cannot be used to make claims that the product meets NIOSH approval requirements.

Page last reviewed: October 29, 2020