Code of Federal Regulations/Title 30/Chapter I-VI/Chapter I/Part 11

by the United States Government

PART 11—RESPIRATORY PROTECTIVE DEVICES; TESTS FOR PERMISSIBILITY; FEES

Subpart A—General Provisions

11.1 Purpose.

11.2 Approved respirators.

11.2-1 Selection, fit, use, and maintenance of approved respirators.

11.3 Definitions.

11.4 Incorporation by reference.

Subpart B—Application for Approval

11.10 Application procedures.

11.11 Contents of application.

11.12 Delivery of respirators and components by applicant; requirements.

Subpart C—Fees

11.20 Examination, inspection, and testing of complete respirator assemblies; fees.

11.21 Examination, imspection, and testing of respirator components or subassemblies; fees.

Sec.

11.22 Unlisted fees; additional fees; payment by applicant prior to approval.

Subpart D—Approval and Disapproveal

11.30 Certificates of approval; scope of approval.

11.31 Certificates of approval; contents.

11.32 Notice of disapproval.

11.33 Approval labels and markings; approval of contents; use.

11.34 Revocation of certificates of approval.

11.35 Changes or modifications of approved respirators; issuance of modification of certificate of approval.

11.36 Delivery of changed or modified approved respirator.

Subpart E—Quality Control

11.40 Quality control plans; filing requirements.

11.41 Quality control plans; contents.

11.42 Proposed quality control plans; approval by the Bureau and the Institute.
Sec.

11.43 Quality control records; review by the Bureau and the Institute; reyooation of approval.

Subpart F—Classification of Approved Respirators; Scope of Approval; Atmospheric Hazards; Service Time

11.50 Types of respirators to be approved; scope of approval.

11.51 Entry and escapes, or escape only; classification.

11.52 Respiratory Hazards; classification

11.53 Service time; classification.

Subpart G—General Construction and Performance Requirements

11.60 Construction and performances requirements; general.

11.61 General construction requirements.

13.62 Component parts; minimum requirements.

11.68 Test requirements; general.

11.64 Pretesting by applicant; approval of test methods.

11.65 Conduct of examinations, inspections, and tests by the Bureau and the Institute; assistance by applicant; observers; recorded data; public demonstrations.

11.68 Withdrawal of applications; refund of fees.

11.70 Self-contained breathing apparatus; description

11.71 Self-contained breathing apparatus; required components.

11.73 Breathing tubes; minimum requirements.

11.73 Harnesses; installation and construction; minimum requirements.

11.74 Apparatus containers; minimum requirements,

11.75 Half-mask facepieces, full facepieces, mouthpieces; fit; minimum requirements.

11.76 Facepieces; eyepieces; minimum requirements.

11.77 Inhalation and exhalation valves; minimum requirements.

11.78 Head harnesses; minimum requirements.

11.79 Breathing gas; minimum requirements.

11.79-1 Interchangeability of oxygen and air prohibited.

11.80 Compressed breathing gas and liquifed breathing gas containers; minimum requirements.

11.81 Gas pressure gauges; minimum requirements,

11.82 Timers; elapsed time indicators; remaining service life indicators; minimum requirements.

Sec.

11.83 Hand-operated valves; minimum requirements.

11.84 Breathing bags; minimum requirements.

11.85 Self-contained breathing apparatus; performance requirements; general.

11.85-1 Component parts exposed to oxygen pressures; minimum requirements.

11.85-2 Compressed gas filters; minimum requirements.

11.85-3 Breathing bag test.

11.85-4 Weight requirement.

11.85-5 Breathing resistance test; inhalation.

11.85-8 Breathing resistance test; exhalation.

11.85-7 Exhalation valve leakage test.

11.85-8 Gas flow test; open-circuit apparatus.

11.85-9 Gas now test; closed-circuit apparatus.

11.85-10 Service time test; open-circuit apparatus.

11.85-11 Service time test; closed-circuit apparatus.

11.85-12 Test for carbon dioxide in inspired gas; open- and closed-circuit apparatus; maximum allowable limits.

11.85-13 Tests during low temperature operation.

11.85-14 Man tests; testing conditions: general requirements.

11.86-15 Man tests 1, 2, 3, an 4; requirements.

11.85-16 Man test 5; requirements.

11.85-17 Man test 6; requirements.

11.85-18 Man tests; performance requirements.

11.85-19 Gas tightness test; minimum requirements.

Subpart I—Gas Masks

11.90 Gas masks; description.

11.91 Gas masks; required components.

11.92 Canisters and cartridges in parallel; resistance requirements.

11.93 Canisters and cartridges; color and markings; requirements.

11.94 Filter used with canisters and cartridges; location; replacement.

11.95 Breathing tubes; minimum requirements.

11.96 Harnesses; installation and construction; minimum requirements.

11.97 Gas mask containers; minimum requirements.

11.98 Half-mask facepieces, full facepieces, and mouthpieces; Alt; minimum requirements.

11.99 Facepieces; eyepieces; minimum requirements.

11.100 Inhalation and exhalation valves; minimum requirements.

11.101 Head harnesses; minimum requirements. Sec.

11.102 Gas masks; performance requirements; general.

11.102-1 Breathing resistance test; minimum requirements.

11.102-2 Exhalation valve leakage test.

11.102-3 Facepiece tests: minimum requirements.

11.102-4 Dust, fume, mist, and smoke tests; canisters containing filters; minimum requirements.

11.103-5 Canister bench tests; minimum requirements.

Subpart J―Supplied-Air Respirators

11.110 Supplied-air respirators: description.

11.111 Supplied-air respirators; required components.

11.112 Breathing tubes; minimum requirements.

11.113 Harnesses: installation and construction: minimum requirements.

11.114 Respirator containers; minimum requirements.

11.115 Half-mask facepieces, full facepieces, hoods, and helmets; fit; minimum requirements.

11.116 Facepieces, hoods, and helmets; eyepieces; minimum requirements.

11.117 Inhalation and exhalation valves; check valves; minimum requirements.

11.118 Head harnesses; minimum requirements.

11.119 Head and neck protection; supplied-air respirators; minimum requirements.

11.120 Air velocity and noise levels; hoods and helmets; minimum requirements.

11.121 Breathing gas; minimum requirements.

11.122 Air supply source; hand-operated or motor driven air blowers; Type A supplied-air respirators; minimum requirements.

11.123 Terminal fittings or chambers; Type B supplied-air respirators; minimum requirements.

11.124 Supplied-air respirators; performance requirements; general.

11.124-1 Hand-operated blower test; minimum requirements.

11.124-2 Motor-operated blower test; minimum requirements.

11.124-3 Method of measuring the power and torque required to operate blowers.

11.124-4 Type B supplied-air respirator; minimum requirements.

11.124-5 Type C supplied-air respirator, continuous flow class; minimum requirements.

11.124-6 Type C supplied-air respirator, demand and pressure demand class; minimum requirements.

11.184-7 Air-supply line tests; minimum requirements.

Sec.

11.184-8 Harness test; minimum requirements.

11.184-9 Breathing tube test; minimum requirements.

11.124-10 Airflow resistance test, Type A and Type AE supplied-air respirators: minimum requirements.

11.124-11 Airflow resistance test; Type B and Type BE supplied-air respirators; minimum requirements.

11.124-12 Airflow resistance test; Type C supplied-air respirator, continuous flow class and Type CE supplied-air respirator; minimum requirements.

11.124-13 Airflow resistance test; Type C supplied-air respirator, demand class; minimum requirements.

11.124-14 Airflow resistance test; Type C supplied-air respirator, pressure-demand class; minimum requirements

11.124-15 Exhalation valve leakage test.

11.124-16 Man tests for gases and vapors; supplied-air respirators; general performance requirements.

11.124-17 Man tests for gases and vapors; Type A and Type A respirators; test requirements.

11.124-18 Man tests for gases and vapors; Type B and Type BE respirators; test requirements.

11.134-19 Man test for gases and vapors; Type C respirators, continuous-flow class and Type CE supplied-air respirators; test requirements.

11.124-20 Man test for gases and vapors; Type C supplied-air respirators, demand and pressure-demand classes; test requirements.

11.124-21 Tests for protection during abrasive blasting; Type AE, Type BE, and Type CE supplied-air respirators; general performance requirements.

11.124-22 Test for protection during abrasive blasting: Type AE supplied-air respirator: test requirements.

11.124-23 Test for protection during abrasive blasting: Type BE supplied-air respirator; test requirements.

11.124-24 Test for protection during abrasive blasting: Type CE supplied-air respirator; test requirements.

Subpart K―Dust, Fume, and Mist Respirators

11.130 Dust, fume, and mist respirators; description.

11.131 Dust, fume and mist respirators; required components.

11.132 Breathing tubes; minimum requirements.
Sec.

11.133 Harnesses; installation and construction; minimum requirements.

11.134 Respirator containers; minimum requirements.

11.135 Half-mask facepieces, full facepieces, hoods, helmets, and mouthpieces; fit; minimum requirements.

11.136 Facepieces, hoods, and helmets; eyepieces; minimum requirements.

11.137 Inhalation and exhalation valves; minimum requirements.

11.138 Head harnesses; minimum requirements.

11.139 Air velocity and noise levels; hoods and helmets; minimum requirements.

11.140 Dust, fume, and mist respirators; performance requirements; general.

11.140-1 Isoamyl acetate tightness test; dust, fume, and mist respirators designed for respiratory protection against fumes of various metals having an air contamination level not less than 0.05 milligram per cubic meter; minimum requirements.

11.140-2 Isoamyl acetate tightness test; respirators designed for respiratory protection against dusts, fumes, and mists having an air contamination level less than 0.05 milligram per cubic meter, or against radionuclides; minimum requirements.

11.140-3 Air-purifying filter tests; performance requirements; general.

11.140-4 Silica dust test; single-use or reusable filters; minimum requirements.

11.140-5 Silica dust test; single-use dust respirators; minimum requirements.

11.140-6 Lead fume test; minimum requirements.

11.140-7 Silica mist test; minimum requirements.

11.140-8 Tests for respirators designed for respiratory protection against more than one type of dispersoid; minimum requirements.

11.140-9 Airflow resistance tests; all dust, fume, and mist respirators; minimum requirements.

11.140-10 Exhalation valve leakage test; minimum requirements.

11.140-11 DOP filter test; respirators designed as respiratory protection against dusts, fumes, and mists having an air contamination level less than 0.05 milligram per cubic meter and against radionuclides; minimum requirements.

11.140-12 Silica dust loading test; respirators designed as protection against dusts, fumes, and mists having an air contamination level less than 0.05 milligram per cubic meter and against radionuclides; minimum requirements.

Subpart L—Chemical Cartridge Respirators Chemical cartridge respirators

11.150 description.

11.151 Chemical cartridge respirators; required components.

11.152 Cartridges in parallel; resistance requirements.

11.153 Cartridges; color and markings; requirements.

11.154 Filters used with chemical cartridges; location; replacement.

11.155 Breathing tubes; minimum requirements.

11.156 Harnesses; installation and construction; minimum requirements.

11.157 Respirator containers; minimum requirements.

11.158 Half-mask facepieces, full facepieces, mouthpieces, hoods, and helmets; fit; minimum requirements.

11.158-1 Facepieces, hoods, and helmets; eyepieces; minimum requirements.

11.159 Inhalation and exhalation valves; minimum requirements.

11.160 Head harnesses; minimum requirements.

11.161 Air velocity and noise levels; hoods and helmets; minimum requirements.

11.162 Chemical cartridge respirators; performance requirements; general.

11.162-1 Breathing resistance test; minimum requirements.

11.162-2 Exhalation valve leakage test; minimum requirements.

11.162-3 Facepiece test; minimum requirements.

11.162-4 Lacquer and enamel mist tests; respirators with filters; minimum requirements; general.

11.162-5 Lacquer mist test; minimum requirements.

11.162-6 Enamel mist test; minimum requirements.

11.162-7 Dust, fume, and mist tests; respirators with filters; minimum requirements; general.

11.162-8 Bench tests; gas and vapor tests; minimum requirements; general.

Subpart M—Pesticide Respirators

11.170 Pesticide respirators; description.

11.171 Pesticide respirators; required components.
Sec.

11.172 Canisters and cartridges in parallel; resistance requirements.

11.473 Canisters and cartridges; color and markings; requirements.

11.174 Filters used with canisters and cartridges; location; replacement.

11.175 Breathing tubes; minimum requirements.

11.176 Harnesses; installation and construction; minimum requirements.

11.177 Respirator containers; minimum requirements.

11.178 Half-mask facepieces, full facepieces, hoods and helmets, and mouthpieces; fit; minimum requirements.

11.179 Facepieces, hoods and helmets; eyepieces; minimum requirements.

11.180 Inhalation and exhalation valves; minimum requirements,

11.181 Head harnesses; minimum requirements.

11.182 Air velocity and noise levels; hoods and helmets; minimum requirements,

11.183 Pesticide respirators; performance requirements; general.

11.183-1 Breathing resistance teat; minimum requirements.

11.183-2 Exhalation valve leakage test; minimum requirements.

11.183-3 Facepiece test; minimum requirements.

11.183-4 Silica dust test; minimum requirements.

11.183-5 Lead fume test; minimum requirements.

11.183-6 Dioctyl-phthalate test; minimum requirements.

11.183-7 Bench tests; minimum requirements.

AUTHORITY: Secs. 2023(h), 204, and 608, 83 Stat. 743, 764 and 803; 30 U.S.C. 842(h). 844 and 957; secs. 2, 8, and 5, 36 Stat. 370, as amended 37 Stat. 681; 30 U.S.C. 3. 5, and 7; sec. 8(g), 84 Stat. 1600; 29 U.B.C. 657(g).

SOURCE: 37 FR 6244, Mar. 25, 1972, unless otherwise noted.

Subpart A—General Provisions

§ 11.1 Purpose.

The purpose of the regulations contained in this Part 11 is: (a) To establish procedures and prescribe requirements which must be met in filing applications for joint approval by the Bureau of Mines and the National Institute for Occupational Safety and Health of respirators or changes or modifications of approved respirators; (b) to establish a schedule of fees to be charged each applicant for the inspections, examinations, and testing conducted by the Institute under the provisions of this part: (c) to provide for the issuance of certificates of approval or modifications of certificates of approval for respirators which have met the applicable construction, performance, and respiratory protection requirements set forth in this part; and (d) to specify minimum requirements and to prescribe methods to be employed by the Institute and by the applicant in conducting inspections, examinations, and tests to determine the effectiveness of respirators used during entry into or escape from hazardous atmospheres.

[37 FR 6246, Mar. 26, 1972, as amended at 38 FR 6993, Mar. 15, 1973]

§ 11.2 Approved respirators.

(a) Until September 30, 1974, respirators or combination of respirators shall be approved for use in hazardous atmospheres where such respirators or combinations of respirators are maintained in an approved condition and are the same in all respects as those respirators:

(1) For which a certificate of approval has been issued under his part; or

(2) Fabricated, assembled, or built under any approval or any modification thereof, issued by the U.S. Bureau of Mines, Department of the Interior, in accordance with the schedules set forth in this paragraph;

(i) Self-contained Breathing Apparatus, Bureau of Mines Schedules 13, March 5, 1919; 13A, January 21, 1930; 13B, August 12, 1935; 13C, July 9, 1946; 13D, September 22, 1956, and 13E, July 19, 1968.

(ii) Gas Masks, Bureau of Mines Schedule 14F, April 23, 1955.

(iii) Supplied-air Respirators, Bureau of Mines Schedule 19B, April 19, 1955.

(iv) Filter-type Dust, Fume, and Mist Respirators, Bureau of Mines Schedule 21B, January 19, 1965.

(v) Nonemergency Gas Respirators, Bureau of Mines Schedule 23B, August 4, 1959.

(b) After September 30, 1974, respirators or combinations of respirators shall be approved for use in hazardous atmospheres where such respirators or combinations of respirators are maintained in an approved condition and are the same in all respects as those respirators: (1) For which a certificate of approval has been issued under this part; or (2) fabricated, assembled, or built under any approval or any modification thereof issued by the U.S. Bureau of Mines in accordance with the schedules set forth in paragraph (a) and in accordance with a quality control plan approved under this part: Provided, That if a respirator is purchased on or before September 30, 1974 and at the time of purchase was the same in all respects as a respirator approved under a Bureau of Mines Schedule, it shall be approved for use until the following dates:

Until March 31, 1979, for self-contained breathing apparatus approved under Bureau of Mines Schedules 13-13E;

Until March 31, 1977, for gas masks approved under Bureau of Mines Schedule 14F,

Until March 31, 1980, for supplied -air respirators approved under Bureau of Mines Schedule 19B,

Until March 31, 1976, for filter-type dust, fume, and mist respirators approved under Bureau of Mines Schedule 21B and for nonemergency gas respirators approved under Bureau of Mines Schedule 23B.

(c) After March 31, 1975, respirators or combinations of respirators shall be approved for use in hazardous atmospheres where such respirators or combinations of respirators are maintained in an approved condition and are the same in all respects as those respirators for which a certificate of approval has been issued under this part: Provided, That if a respirator is purchased on or before March 31, 1975, and at the time of purchase was the same in all respects as a respirator approved under a Bureau of Mines Schedule and was manufactured pursuant to a quality control plan approved under this part, it shall be approved for use until the following dates:

Until March 31, 1979, for self-contained breathing apparatus approved under Bureau of Mines Schedule 13-13E;

Until March 31, 1977, for gas masks approved under Bureau of Mines Schedule 14F;

Until March 31, 1980, for supplied-air respirators approved under Bureau of Mines Schedule 19B;

Until March 31, 1976, for filter-type dust, fume, and mist respirators approved under Bureau of Mines Schedule 21B and for nonemergency gas respirators approved under Bureau of Mines Schedule 23B.

[39 FR 12864, Apr. 9, 1974]

§ 11.2-1 Selection, fit, use, and maintenance of approved respirators.

In order to insure the maximum amount of respiratory protection, approved respirators shall be selected, fitted, used, and maintained in accordance with the provisions of the American National Standard Practices for Respiratory Protection, Z88.2, obtainable from American National Standards Institute, Inc., 1430 Broadway, New York, NY 10018.

§ 11.3 Definitions.

As used in this part―

(a) "Air Contamination Level" means the standards of contaminant levels prescribed by the Secretary of Labor in accordance with the provisions of the Occupational Safety and Health Act of 1970 (Public Law 91-596; 84 Stat. 1590).

(b) "Applicant" means an individual, partnership, company, corporation, association, or other organization that designs, manufactures, assembles, or controls the assembly of a respirator and who seeks to obtain a certificate of approval for such respirator.

(c) "Approval" means a certificate or formal document issued by the Bureau and the Institute stating that an individual respirator or combination of respirators has met the minimum requirements of this Part 11, and that the applicant is authorized to use and attach an approval label to any respirator, respirator container, or instruction card for any respirator manufactured or assembled in conformance with the plans and specifications upon which the approval was based, as evidence of such approval.

(d) "Approved" means conforming to the minimum requirements of this Part 11.

(e) "Auxiliary equipment" means a self-contained breathing apparatus, the use of which is limited in underground mine rescue and recovery operations to situations where the wearer has ready access to fresh air and at least one crew equipped with approved self-contained breathing apparatus of 2 hours or longer rating, is in reserve at a fresh-air base.

(f) "Bureau" means the U.S. Bureau of Mines, Department of the Interior.

(g) "Compressed breathing gas" means oxygen or air stored in a compressed state and supplied to the wearer in gaseous form.

(h) "Concentration limits for radionuclides" means the concentration limits set forth in Appendix B, Table 1, Column I of Title 10 CFR Part 20 by the Atomic Energy Commission.

(i) "dBA" means sound pressure levels in decibels, as measured with the A-weighted network of a standard sound level meter using slow response. (j) "DOP" means a homogeneous liquid aerosol, having a particle diameter of 0.3 micrometer, which is generated by vaporization and condensation of dioctyl phthalate.

(k) "Dust" means a solid mechanically produced particle with a size ranging from submicroscopic to macroscopic.

(l) Respirators "for entry into and escape from" means respiratory devices providing protection during entry into and escape from hazardous atmospheres.

(m) Respirators "for escape only" means respiratory devices providing protection only during escape from hazardous atmospheres.

(n) A "facepiece" or "mouthpiece" is a respirator component designed to provide a gas-tight or dust-tight fit with the face and may include headbands, valves, and connections for canisters, cartridges, filters, or respirable gas source.

(o) "Final inspection" means that activity carried out on a product after all manufacturing and assembly operations are completed to insure completeness and adherence to performance or other specifications, including satisfactory appearance.

(p) "Fume" means a solid condensation particle, generally less than 1 micrometer in diameter.

(q) "Gas" means an aeriform fluid which is in a gaseous state at ordinary temperature and pressure.

(r) "Hazardous atmosphere" means:

(1) Any atmosphere containing a toxic or disease producing gas, vapor, dust, fume, mist, or pesticide, either immediately or not immediately dangerous to life or health; or (2) any oxygen-deficient atmosphere.

(s) A "hood" or "helmet" is a respirator component which covers the wearer's head and neck, or head, neck, and shoulders, and is supplied with incoming respirable air for the wearer to breathe. It may include a headharness and connection for a breathing tube.

(t) "Immediately dangerous to life or health" means conditions that pose an immediate threat to life or health or conditions that pose an immediate threat of severe exposure to contaminants, such as radioactive materials, which are likely to have adverse cumulative or delayed effects on health.

(u) "Incoming inspection" means the activity of receiving, examining, and accepting only those materials and parts whose quality conforms to specification requirements.

(v) "In-process inspection" means the control of products at the source of production and at each step of the manufacturing process, so that departures from specifications can be corrected before defective components or materials are assembled into the finished product.

(w) "Institute" means the National Institute for Occupational Safety and Health, Department of Health, Education, and Welfare.

(x) " Liquefied breathing gas" means oxygen or air stored in liquid form and supplied to the wearer in a gaseous form.

(y) "Mist" means a liquid condensation particle with a size ranging from submicroscopic to macroscopic.

(z) "Not immediately dangerous to life or health" means any hazardous atmosphere which may produce physical discomfort immediately, chronic poisoning after repeated exposure, or acute adverse physiological symptoms after prolonged exposure.

(aa) "Oxygen deficient atmosphere" means an atmosphere which contains an oxygen partial pressure of less than 148 millimeters of mercury (19.5 percent by volume at sea level).

(bb) "Pesticide" means (1) any substance or mixture of substances (including solvents and impurities) intended to prevent, destroy, repel, or mitigate any insect, rodent, nematode, fungus, weed, or other form of plant or animal life or virus, and (2) any substance or mixture of substances (including solvents and impurities) intended for use as a plant regulator, defoliant, or desiccant, as defined in the Federal Insecticide, Fungicide, and Rodenticide Act of 1947, as amended (7 U.S.C. 135-135k), excluding fumigants which are applied as gases or vapors or in a solid or liquid form as pellets or poured liquids for subsequent release as gases or vapors.

(cc) "Powered air-purifying respirator" means a device equipped with a facepiece, hood, or helmet, breathing tube, canister, cartridge, filter, canister with filter, or cartridge with filter, and a blower.

(dd) "Radionuclide" means an atom identified by the constitution of its nucleus (specified by the number of protons Z, number of neutrons N, and energy, or, alternatively, by the atomic number Z, mass number A=(N+Z), and atomic mass) which exists for a measurable time; decays or disintegrates spontaneously, emits radiation, and results in the formation of new nuclides. (ee) "Respirable dust" means a dust particle aerodynamically capable of reaching the terminal airways of the lung.

(ff) "Respirator" means any device designed to provide the wearer with respiratory protection against inhalation of a hazardous atmosphere.

(gg) "Smoke" means the products of incomplete combustion of organic substances in the form of solid and liquid particles and gaseous products in air, usually of sufficient concentration to perceptibility obscure vision.

(hh) "Testing and Certification Laboratory" means the Testing and Certification Laboratory, National Institute for Occupational Safety and Health, 944 Chestnut Ridge Road, Morgantown, WV 26505.

(ii) "Vapor" means the gaseous state of a substance that is solid or liquid at ordinary temperature and pressure.

[37 FR 6244, Mar. 25, 1972, as amended at 38 FR 6993, Mar. 15, 1973]

§ 11.4 Incorporation by reference.

In accordance with 5 U.S.C. 552(a)(1), the technical publications to which reference is made in this Part 11, and which have been prepared by organizations other than the Bureau or the Institute, are hereby incorporated by reference and made a part hereof. The incorporated technical publications are available for examination at Approval and Testing, Health and Safety Technical Support Center, Bureau of Mines, 4800 Forbes Avenue, Pittsburgh, PA 15213, and at the Testing and Certification Laboratory. In addition, copies of the American National Standards Institute Standard Z88.2—1969, "Practices for Respiratory Protection," are available for examination in every Coal Mine Health and Safety District and Subdistrict Office.

[38 FR 6999, Mar. 15, 1973]

Subpart B—Application for Approval

§ 11.10 Application procedures.

(a) Inspection, examination, and testing leading to the approval of the types of respirators classified in Subpart F of this part shall be undertaken hy 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 Testing and Certification Laboratory, 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 § 11.64 and in paragraph (e) of this section, the examination, inspection, and testing of all respirators shall be conducted by the Testing and Certification Laboratory.

(d) Applicants, manufacturers, of their representatives may visit or communicate with the Testing and Certification Laboratory 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) Inspection, examination, and testing of electrical components of respirators that are required to be permissible shall be tested in accordance with Part 18 of this chapter, and such components shall be submitted to Approval and Testing, Bureau of Mines, 4800 Forbes Avenue, Pittsburgh, PA 15213.

[38 FR 6993, Mar. 15, 1973]

§ 11.11 Contents of application.

(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, Drawings and specifications (and lists thereof) shall be submitted :n triplicate.

(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 § 11.64, 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 (1) prototypes, or (2) made on regular production tooling, with no operation included which will not be