42 C.F.R. Subpart B—Application for Approval
Title 42 - Public Health
(a) Inspection, examination, and testing leading to the approval of the types of respirators classified in subpart F of this part shall be undertaken by the Institute only pursuant to written applications which meet the minimum requirements set forth in this subpart B. (b) Applications shall be submitted to the Certification and Quality Assurance Branch, and shall be accompanied by a check, bank draft, or money order in the amount specified in subpart C of this part, payable to the order of the National Institute for Occupational Safety and Health. (c) Except as provided in §84.64, the examination, inspection, and testing of all respirators shall be conducted by the Certification and Quality Assurance Branch. (d) Applicants, manufacturers, or their representatives may visit or communicate with the Certification and Quality Assurance Branch in order to discuss the requirements for approval of any respirator or the proposed designs thereof. No charge shall be made for such consultation and no written report shall be issued to applicants, manufacturers, or their representatives by the Institute as a result of such consultation. (e) Respirators having electrical or electronic components that are required to be permissible under chapter I of title 30 shall be tested in accordance with 30 CFR part 18. Applications for approval of such respirators by MSHA shall be submitted in writing to: MSHA, Approval and Certification Center, Box 251, Industrial Park Road, Triadelphia, West Virginia 26059. (a) Each application for approval shall contain a complete written description of the respirator for which approval is requested together with drawings and specifications (and lists thereof) showing full details of construction of the respirator and of the materials used. (b) Drawings shall be titled, numbered, and dated; any revision dates shall be shown on the drawings, and the purpose of each revision being sought shall be shown on the drawing or described on an attachment to the drawing to which it applies. (c) Each application for approval shall contain a proposed plan for quality control which meets the minimum requirements set forth in subpart E of this part. (d) Each application shall contain a statement that the respirator has been pretested by the applicant as prescribed in §84.64, and shall include the results of such tests. (e) Each application for approval shall contain a statement that the respirator and component parts submitted for approval are either prototypes, or made on regular production tooling, with no operation included which will not be incorporated in regular production processing.
Title 42: Public Health
PART 84—APPROVAL OF RESPIRATORY PROTECTIVE DEVICES
Subpart B—Application for Approval
§ 84.10 Application procedures.
§ 84.11 Contents of application.
§ 84.12 Delivery of respirators and components by applicant; requirements.
(a) Each applicant shall, when an application is filed pursuant to §84.10, be advised by the Institute of the total number of respirators and component parts required for testing.
(b) The applicant shall deliver, at his own expense, the number of completely assembled respirators and component parts required for testing, to the Certification and Quality Assurance Branch.
(c) Respirators and component parts submitted for approval must be made from materials specified in the application.
(d) One completely assembled respirator approved under the provisions of this part may be retained by the Institute as a laboratory exhibit, the remaining respirators may be returned to the applicant at his own expense, upon written request within 30 days after notice of approval. If no such request is made, the respirators will be disposed of by the Institute in such manner as it deems appropriate.
(e) Where a respirator fails to meet the requirements for approval set forth in this part, all respirators and components delivered in accordance with this section may be returned to the applicant at his own expense, upon written request within 30 days after notice of disapproval. If no such request is made, the respirators will be disposed of by the Institute in such manner as it deems appropriate.
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