NIOSH Fact Sheet

NIOSH approval labels— and specifications upon which the certificate of approval is based, key information to protect (§84.33[f]). yourself Approval labels contain important By R. Metzler and J. Szalajda information to assist users in The National Institute for Occupational understanding the respirator, its Safety and Health (NIOSH) specifies protections, cautions and limitations, and minimum approval requirements for approved configuration of components. respiratory protective devices in Title 42 How can NIOSH approval labels Code of Federal Regulations (CFR) Part 84. NIOSH reviews respirator approval help respirator wearers? applications, which contain technical NIOSH approval labels used in specifications, drawings, and other conjunction with the applicant’s user related information. NIOSH also inspects, instructions provide essential examines and tests the respirators to information to know if the configured determine that the applicable RPD (respirator assembly) is NIOSH- requirements are met for individual, approved, as well as key information for completely assembled respirators, as the safe and appropriate use of the RPD. described in §84.30(a). Full labels for the respirator (facepiece) Certificates of approval are issued for a and the air-purifying component contain respiratory protective device (RPD) that the most complete information and can meets the applicable requirements. be used to determine if the respirator Certificates of approval are not issued for assembly is configured as approved by any individual respirator components NIOSH. (§84.30[b]). Use of components not listed on the full Each certificate of approval includes NIOSH approval label constitutes labels to be provided by the applicant configurations not included in the with each approved respirator assembly NIOSH approval and can cause serious (§84.31[d]). The applicant is the injury and/or death to the wearer. individual, partnership, company, corporation, association, or other Samples of a full respirator and air- organization that designs, manufactures, purifying component label are shown assembles, or controls the assembly of a below. These are excerpts from NIOSH respirator and who seeks to obtain a publication, Standard Application certificate of approval for the respirator Procedure for the Certification of (§84.2[a]). Respirators under 42 CFR 84, Revision 1, July 2005. The NIOSH web site location is: The use of the NIOSH label obligates the http://www.cdc.gov/niosh/npptl/resour applicant to whom it was issued to ces/certpgmspt/pdfs/SAPJul2005.pdf) maintain the quality level of manufactured respirators and assure that the RPD is manufactured to the drawings DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Institute for Occupational Safety and Health

What labels and markings are part number and lot number. They may required by NIOSH? be an adhesive label placed on the cartridge or filter, or may be printed on NIOSH approval labels are described in the container. They are also placed on 42CFR84 (§84.33), and the information filtering facepiece respirators (most often they provide and their locations differ printed) where the filter is the complete depending on the respirator type. respirator. Other individual respirator components (e.g., facepiece, blower, and These labels are referred to as “entire” or hose) are not required by NIOSH to be “abbreviated” (§84.33[e]). However, marked with a NIOSH emblem. these labels do not identify the approved respirator’s complete configuration of For quality control purposes, NIOSH components. requires that each respirator, respirator component, and respirator container be NIOSH may also require additional labels, labeled distinctly to show the lot number, markings, or instructions (§84.33[c]). serial number, or approximate date of Accordingly, NIOSH also requires a “full” manufacture of the component label for the respirator be provided with (§84.33[g]). the facepiece, and one for each air- purifying component. A full NIOSH What information is included on approval label contains the most useful the full NIOSH approval label? and important information. It contains Full approval labels list the NIOSH the NIOSH emblem, the applicant’s name approval number (TC column), protection and address, an approval number level, component with part number, and assigned by NIOSH, protections, cautions caution and limitation (C&L) statements and limitations of use placed on the RPD in the form of a table or matrix of by NIOSH, and the unique information. Each row of the matrix configurations of components approved contains a unique approval number with by NIOSH. These are labels printed on intersecting columns identifying the paper and distributed with the protection, components, and C&L manufacturer’s user instructions with statements (designated by letters). The each RPD facepiece and air-purifying actual C&L statements are written below component. the matrix.

The label attached to the self-contained An “X” placed in the box formed by the breathing apparatus (SCBA) harness row/column intersection means that the assembly and gas mask canisters are component is part of the approved examples of entire labels. They contain configuration for the row containing the the NIOSH emblem, the applicant’s name approval number, protection, and C&L and address, an approval number statements. The absence of an “X” means assigned by NIOSH, protections, cautions that the component is not a component of and limitations of use placed on the RPD that approved configuration. by NIOSH. They do not contain the unique configurations of components Approval Number (first column) approved by NIOSH. The certificate of approval will have an approval number. The number provides a Labels attached to individual cartridges considerable amount of information and filters, and filter containers are about the RPD, including the category of examples of abbreviated labels 42CFR84 standards that the respirator (§84.33[e]). These labels contain the assembly meets. The number consists of NIOSH emblem, protection, manufacturer three parts: Part 1—TC (Testing and Certification). Where (SC) is self contained, (PD) All NIOSH approval numbers begin with pressure demand, 30 is rated duration (in the letters TC. minutes), and 2,216 is gauge pressure in pounds per square inch. Part 2—Approval Schedule (set of standards). The numbers and letter Chemical cartridge—“OV/P100” indicate the set of standards applicable to Where (OV) is organic vapor and P100 is a specific respirator type. particulate filter efficiency 99.97%. These number/letter designations represent the original approval schedule Supplied-air—“SA/CF (number) and revision level (letter) used by the U.S. Bureau of Mines (except for Where (SA) is supplied air, (CF) is 84A). continuous flow. NIOSH uses the following designations: Each label defines the abbreviations used 13F: self-contained breathing apparatus to describe a protection. (SCBA) 19C: supplied air respirator (SAR) Components (middle columns) 14G: gas mask with canister Each certificate of approval may include 23C: air-purifying respirator (APR) with specific alternate or optional components. chemical cartridge or powered air- Each component (column) is listed with a purifying respirator (PAPR) with unique part number assigned by the chemical cartridge and particulate applicant. Several alternate facepieces, filter cartridges, head harnesses, batteries, or 21C: powered air-purifying respirator other components may be listed. with particulate filter However, only those components 84A: respirator with particulate filter or indicated with an “X” are part of the combination chemical cartridge approved respirator assembly for a with particulate filter specific approval number (row). If an “X” is not in the box, the component Part 3—Unique number assigned by is not a part of the approved assembly. NIOSH (e.g., 0123; 2341). Caution and Limitation (C&L) Examples of respirator type approval Statements (last column) numbers are: NIOSH requires the applicant to list SCBA TC-13F-0123 specific C&L statements for each APR TC-23C-4567 respirator type, and this key information Particulate or combination TC-84A-8901 is needed to understand the restrictions including particulate for its use. C&L statements address topics

such as oxygen deficiency, maximum use Protection (second column) concentrations, end of service life, airflow Each approval number is provided in a rates, and flammable or explosive row, and the type and level of protection atmospheres. These C&L statements must provided under that approval number is be understood to avoid personal injury identified in the “Protection” column. The and to assure the effective use of the RPD. protection varies by the type of Used with the manufacturer’s user respirator. Examples for various instructions, NIOSH approval labels can respirator types include the following: help users understand the respirator, SCBA—“SC/PD 30 min 2216 psig” its protections, cautions and limitations, and approved configuration of components.

To receive other documents or other information about occupational safety and health topics, contact NIOSH at Telephone: 1–800–CDC–INFO (1–800–232–4636) TTY: 1–888–232–6348 ■ E-mail: [email protected] or visit the NIOSH Web site at www.cdc.gov/niosh For a monthly update on news at NIOSH, subscribe to NIOSH eNews by visiting www.cdc.gov/niosh/eNews.

This document is in the public domain and may be freely copied or reprinted.

As part of the Centers for Disease Control and Prevention, NIOSH is the Federal agency responsible for conducting research and making recommendations to pre- vent work-related illnesses and injuries. Fact sheets describe how worker exposures to hazardous agents or activities can be reduced. Mention of any company or product does not constitute endorsement by NIOSH. In addition, citations to Web sites external to NIOSH do not constitute NIOSH endorsement of the sponsoring organizations or their programs or products. Fur- thermore, NIOSH is not responsible for the content of these Web sites.

DHHS (NIOSH) Publication No. 2011–179 SAFER • HEALTHIER • PEOPLETM May 2011

DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Institute for Occupational Safety and Health 4676 Columbia Parkway Cincinnati, OH 45226–1998

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