42 C.F.R. § 84.33   Approval labels and markings; approval of contents; use.


Title 42 - Public Health


Title 42: Public Health
PART 84—APPROVAL OF RESPIRATORY PROTECTIVE DEVICES
Subpart D—Approval and Disapproval

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§ 84.33   Approval labels and markings; approval of contents; use.

(a) Full-scale reproductions of approval labels and markings, and a sketch or description of the method of application and position on the harness, container, canister, cartridge, filter, or other component, together with instructions for the use and maintenance of the respirator shall be submitted to the Institute for approval.

(b) Approval labels shall bear the emblem of the National Institute for Occupational Safety and Health and the seal of the Department of Health and Human Services, the applicant's name and address, an approval number assigned by the Institute and, where appropriate, restrictions or limitations placed upon the use of the respirator by the Institute. The approval number assigned by the Institute shall be designated by the prefix TC and a serial number.

(c) The Institute shall, where necessary, notify the applicant when additional labels, markings, or instructions will be required.

(d) Approval labels and markings shall only be used by the applicant to whom they were issued.

(e) Legible reproductions or abbreviated forms of the label approved by the Institute for use on each respirator shall be attached to or printed at the following locations:

 ------------------------------------------------------------------------        Respirator type             Label type            Location------------------------------------------------------------------------Self-contained breathing        Entire...........  Harness assembly and apparatus.                                         canister (where                                                    applicable).Gas mask......................  Entire...........  Mask container and                                                    canister.Supplied air respirator.......  ......do.........  Respirator container                                                    or instruction card.Particulate respirator........  ......do.........  Respirator container                                                    and filter                                                    container.                                Abbreviated......  Filters.Chemical-cartridge respirator.  Entire...........  Respirator container,                                                    cartridge container,                                                    and filter                                                    containers (where                                                    applicable).                                Abbreviated......  Cartridges and                                                    filters and filter                                                    containers.------------------------------------------------------------------------

(f) The use of any Institute approval label obligates the applicant to whom it is issued to maintain or cause to be maintained the approved quality control sampling schedule and the acceptable quality level for each characteristic tested, and to assure that it is manufactured according to the drawings and specifications upon which the certificate of approval is based.

(g) Each respirator, respirator component, and respirator container shall, as required by the Institute to assure quality control and proper use of the respirator, be labeled distinctly to show the name of the applicant, and the name and letters or numbers by which the respirator or respirator component is designated for trade purposes, and the lot number, serial number, or approximate date of manufacture.

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