Conformity Assessment Notices

For Everyone

At a glance

NIOSH notices and letters provide important information for applicants, approval holders, and respirator users. Documents are organized by number in the accordions below. Documents issued in 2017 and earlier are grouped separately at the bottom.

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About

There are four types of Conformity Assessment Notices:

  1. Respiratory Protective Device Information: Announcements to inform users of changes to the approval status of specific respirator models or to alert about potential counterfeit or misrepresented products.
  2. Conformity Assessment Interpretation: An explanation of a NIOSH actions or positions, such as changes to the respirator approval process or requirements.
  3. Conformity Assessment Letters to Manufacturers: Announcements impacting NIOSH approval holders.
  4. Conformity Assessment Notices: Documents developed to reaffirm a NIOSH conformity assessment process or procedure.

All new applicants are encouraged to review relevant NIOSH CANs and letters before submitting an application for NIOSH approval. These notices can be found at Respirator Approval: How to Apply along with an overview of the NIOSH approval process.

All manufacturers must meet the regulatory requirements stated in 42 Code of Federal Regulations Part 84 to become NIOSH approval holders.

Conformity Assessment Notices

Letters issued to manufacturers and interested parties (2017 and earlier)

September 28, 2017 – NIOSH NPPTL Meeting for All Respirator Manufacturers, Thursday, December 7, 2017
August 30, 2016 – NIOSH NPPTL Meeting for All Respirator Manufacturers, Wednesday, November 16, 2016
April 16, 2010 – Revised Breakthrough Levels for Gas Masks
May 15, 2015 – NIOSH Respirator Certificate of Approval, Approval Labels, and User Instructions
March 5, 2015 – Change of NPPTL Mailing Address
February 3, 2015 – Implementation Plan for Respirator Certification Fees
September 30, 2014 – Site Audit Program Questions and Answers
September 8, 2014 – Respirator Manufacturers Meeting, October 22, 2014
August 22, 2014 – Chemical Warfare Agent Test Fees
July 10, 2014 – Information for Respirator Manufacturers Meetings, September 18 and October 22)
July 25, 2013 – Respirator Manufacturers Meeting, September 18, 2013
September 24, 2012 – Respirator Sampling Procedures
August 21, 2012 – Respirator Manufacturers Meeting, October 3, 2012
July 10, 2012 – NIOSH Initiation of Respirator Certification of Respirators with Protections for Wildland Fire-Fighting Operations
August 5, 2011 – Respirator Manufacturers Meeting, September 14, 2011
February 17, 2011 – Respirator Manufacturers Meeting, July 26-28, 2011
April 27, 2010 – Respirator Manufacturers Meeting, July 14, 2010
April 16, 2010 – Revised Breakthrough Levels for Gas Masks
April 13, 2010 – Respirator Manufacturers Meeting, August 24-26, 2010
October 15, 2009 – To All Filtering Facepiece Approval Holders
March 31, 2009 – Respirator Manufacturers Meeting, May 12, 2009
March 17, 2009 – Extended Testing (Default to Test) Policy
March 10, 2009 – Approval of Filtering Facepiece Respirators with Novel Head Suspension Systems. [The March 10, 2009 Letter to All Manufacturers titled Approval Of Filtering Facepieces With Novel Head Suspension Systems is rescinded effective May 8, 2009]
September 03, 2008 – Filtering Facepiece Respirator Label
December 12, 2007 – RespiDecember 12, 2007 – Respirator Manufacturers Meeting January 24, 2008rator Manufacturers Meeting January 24, 2008
July 12, 2007 – Reminder – Information Request for Respirator Audit Logic Database
July 11, 2007 – Reminder – Information Request for Respirator Audit Logic Database
July 11, 2007 – Revised fees for CBRN respirator approvals, effective April 1, 2007
June 14, 2007 – Clarification on the Purpose of Posting Standard Test Protocols
April 10, 2007 – Respirator Manufacturers Meeting April 10th, 11th, and 12th, 2007
April 3, 2007 – Update to the NIOSH CBRN Full Facepiece APR Mechanical Connector and Gasket Drawing from Revision 2 (January 9, 2004) to Revision 3 (April 3, 2007)
February 27, 2007 – Respirator Manufacturers Meeting April 10th, 11th, and 12th, 2007
December 8, 2006 – NIOSH NPPTL and NFPA Joint Approval Process for NFPA 1981 2007 Edition Respirator Approvals
November 3, 2006 – Information Request for Respirator Audit Logic Database Reminder
October 2, 2006 – NIOSH Policy for Respirator Sealing Surfaces and Facial Hair
August 14, 2006 – Respirator Manufacturers Meeting, October 11, 2006
June 15, 2006 – Revised Cautions an Limitations List for CBRN APR
March 17, 2006 – Meaning of NIOSH Approval
March 16, 2006 – Public Meeting to be held on April 27, 2006, to Discuss Expediting the Respirator Certification Process, Isoamyl Acetate (IAA) Testing, N95 Filtering Facepiece Priority, CBRN NFPA 1981 Standard, and Changes to Post-Certification Audit Selection
March 16, 2006 – Revised fees for CBRN respirator approvals, effective April 1, 2006
January 10, 2006 – Clarification of use of manufacturer’s pretest data
November 15, 2005 – Respirator Manufacturers Meeting December 12, 2005 manufacturers’ meeting to discuss Silica dust tests for PAPR, Standard Application Procedures, and tour the NIOSH/NPPTL Facility
August 29, 2005 – Revocation of Cylinder Exemption DOT-E-12695
August 26, 2005 – Revised Standard Application Procedures for the Certification of Respirators
May 20, 2005 – July 21, 2005 meeting to discuss Standard Application Procedures
May 18, 2005 - Air-Purifying Fit Test Subject Selection
April 22, 2005 – Unique Part Numbers; Abbreviated Labeling Options for Cartridges and Filters
April 7, 2005 – Clarification of Supplier and Subcontractor Relationships
March 11, 2005 – Meeting to discuss the Standard Application Procedures (SAP) comments, implementation of the procedures, new NPPTL and Respirator Branch organizational structures, and follow-up on replacement documents
November 16, 2004 – Meeting to address new NPPTL and Respirator Branch organizational structures, availability of revised Standard Application Procedures for comment, and concepts for Respirator Branch process and procedure changes
July 10, 2002 – Relocation of NIOSH’s Respirator Branch to the National Personal Protective Technology Laboratory (NPPTL)

October 2, 2017 – Applications for Approval of Self-Contained Breathing Apparatus (SCBA) Intended to Meet the Requirements of National Fire Protection Association (NFPA) 1986, Standard on Respiratory Protection Equipment for Tactical and Technical Operations, 2017 edition
May 9, 2017 – Incorporation of National Fire Protection Association (NFPA) 1986, Standard on Respiratory Protection Equipment for Tactical and Technical Operations, 2017 edition into NIOSH policy statement on “Evaluation and Acceptance of Emergency Breathing Support Systems (EBSS) incorporated into SCBA Approvals”
March 29, 2017 – ISRP Americas Section Technical and Annual General Meeting, September 13, 2017
January 15, 2016 – First NIOSH/MSHA Approval for Large-Capacity (Cap 3) Closed-Circuit Escape Respirator
April 7, 2015 – Certification Standards for Closed-Circuit Escape Respirators
February 18, 2015 – NIOSH NPPTL Webinar Concerning Standard for Performance Requirements of the Combination Unit Respirator
August 7, 2014 – N95 Day Webinar – Respirator Preparedness in Healthcare: Where Technology Meets Good Practices
July 24, 2014 – NIOSH Update: NIOSH Issues First Closed-Circuit Escape Respirator Approval Under New Certification Requirements
February 18, 2014 – Evaluation and Acceptance of Emergency Breathing Support Systems (EBSS) Incorporated into SCBA Approvals
March 27, 2013 – NIOSH Public Meeting: Amendments to Respirator Certification Fees
December 6, 2010 – PPT Stakeholders Meeting, March 29, 2011
November 19, 2010 – Workshop on Respirator Approval Labels
October 25, 2010 – Announcement of public meeting to be held December 9, 2010 concerning (1) the NIOSH Regulatory Agenda for updating 42 CFR Part 84, (2) Standards Development for CBRN Combination Unit Respirators (Any combination of an air-purifying and air-supplied respirator), and (3) Standards Development for Buddy Breathing with a Self-Contained Breathing Apparatus (SCBA).
June 23, 2010 – Background and Summary of CSE SR-100 Investigations
July 7, 2009 – Announcement of Public Meeting to be held September 17, 2009 to discuss Supplied-Air Respirators, Air Fed Ensembles, and Total Inward Leakage Test for Respirators other than Filtering Facepiece and Half Masks
March 4, 2009 – Notice of Proposed Rulemaking; Reopening Of Comment Period And Notice Of Public Meetings: Closed-Circuit Escape Respirators
March 4, 2009 – Notice of Proposed Rulemaking: Reopening of comment period and notice of public meetings: Quality Assurance for Respirators
January 8, 2009 – Personal Protective Technology Program Stakeholders Meeting to be held March 3, 2009
December 02, 2008 – National Personal Protective Technology Laboratory Stakeholder Meeting, December 02, 2008
July 10, 2008 – National Personal Protective Technology Laboratory Stakeholder Meeting, August 20, 2008
January 25, 2008 – National Personal Protective Technology Laboratory Stakeholder Meeting, March 6, 2008
January 17, 2008 – Colors for Respirator Element Labeling
January 8, 2008 – Powered Air-Purifying Respirator (PAPR) Concept Paper
August 30, 2007 – Incorporation of the NIOSH CBRN Full Facepiece APR Mechanical Connector and Gasket drawing Revision 4, Dated 09 July 2007, into the Statement of Standard for Chemical, Biological, Radiological and Nuclear (CBRN) Full Facepiece Air-Purifying Respirator (APR), Revision 2; April 4, 2003
July 20, 2007 – Time extension to submit comments on the Total Inward Leakage program for half-mask air-purifying particulate filtering respirator certification
May 29, 2007 – TIL Public Meeting
March 1, 2007 – March 22, 2007 Meeting to discuss Long Term Field Evaluation Concept
October 20, 2006 – Time extension to submit comments on the Closed-Circuit Escape Respirators (CCER) Concept Requirements
October 6, 2006 – Voluntary Program for Acceptance of Applications for the Testing and Evaluation of Powered Air-Purifying Respirators (PAPR or PAPRS) for Use Against Chemical, Biological, Radiological and Nuclear (CBRN) Agents
October 6, 2006 – CBRN Combination SCBA and CBRN Supplied Air respirator concepts
August 21, 2006 – Closed-Circuit Escape Respirator (CCER) Public Meetings
August 14, 2006 – National Personal Protective Technology Laboratory Public Meeting
November 15, 2005 – December 13, public meeting to discuss concepts for standards for CBRN respirators and multi-function PAPRs
June 23, 2005 – July 19-20, 2005 meeting to discuss Concepts for Standards for Approval of Respirators for Use Against Chemical, Biological, Radiological and Nuclear Agents (CBRN) and Guidelines for Their Use; and Concepts for Standards for a Multi-Function Powered Air-Purifying Respirator (PAPR)
July 14, 2004 – Public Meeting to be held on August 25, 2004, to Begin Initial Discussions for Concepts of Total Inward Leakage (TIL) Requirements and Test Methods for Halfmask Respirators Including Elastomeric and Filtering Facepiece Styles
June 6, 2003 – Announcement of a Respirator Certification Process Workshop to be Held on June 26, 2003
March 12, 2003 – Announcement of a Meeting to be held April 10, 2003 to Discuss Standards for Multifunction Powered Air-Purifying Respirators (PAPRs)
March 11, 2003 – Announcement of Meetings to be held on April 10, 2003, and April 24, 2003, to Discuss the Approval of Respiratory Devices Used to Protect Workers in Hazardous Environments

May 9, 2017 – Incorporation of National Fire Protection Association (NFPA) 1986, Standard on Respiratory Protection Equipment for Tactical and Technical Operations, 2017 edition into NIOSH Self-Contained Breathing Apparatus (SCBA) policy statement on “Acceptance of Applications for the Testing and Evaluation of Self-Contained Breathing Apparatus for Use against Chemical, Biological, Radiological and Nuclear Agents”
November 12, 2004 – Public Meeting to be held on December 15, 2004, to Continue Discussions for Concepts of Powered Air-Purifying Respirator (PAPR) Standards and Introduction of Concepts for Closed-Circuit, Self Contained, Breathing Apparatus Standards Development Efforts Used for Respiratory Protection Against CBRN Agents
March 26, 2004 – Public Meeting May 4, 2004, to Continue Discussions for Powered Air-Purifying Respirator (PAPR) Standards Used for Respiratory Protection Against CBRN Agents
September 24, 2003 – Announcement of Two Public Meetings to be held on October 16, 2003 to Initiate Conceptual Discussions for Powered Air-Purifying Respirator Standards for Protection Against CBRN Agents, and Quality Assurance Standards Module for Respiratory Protective Equipment
June 4, 2003 – Announcement of a Public Meeting – June 25, 2003, to Continue Conceptual Discussions for Escape Respirator Standards Development Efforts for Protection Against CBRN Agents, and Provide an Update on the Quality Assurance/Administrative Module
April 10, 2003 – Public Meeting to be held on April 29, 2003, to Continue Conceptual Discussions for Escape Respirator Standards Used for Respiratory Protection Against CBRN Agents
September 23, 2002 – Announcement of a Public Meeting on October 16 & 17, 2002, to Discuss Standards Development Efforts for Full Facepiece Air-Purifying Respirators (APR) Used to Protect Emergency Response Workers Against Chemical, Biological, Radiological and Nuclear (CBRN) Agents and Air-Purifying Escape Respirators to Protect Workers Against CBRN Agents
May 24, 2002 – Announcement of a Public Meeting to Discuss Standards Development Efforts for Full Facepiece Air-Purifying Respirators (APR) Used to Protect Emergency Response Workers Against Chemical, Biological, Radiological and Nuclear (CBRN) Agents
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Content Source
National Institute for Occupational Safety and Health
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Published: April 23, 2025
Updated: January 5, 2025

This page was last updated on this date. Updates may include minor edits, image changes, or other modifications to page content.

Reviewed: January 21, 2025

The information on this page was last reviewed by subject matter experts to ensure accuracy.