美国N95口罩标准正文42 CFR Part 84-particulate respirator mask NIOSH OSHA

PART 84—APPROVAL OF RESPIRATORY PROTECTIVE DEVICES

Subpart A—General Provisions
84.1 Purpose.

Pt. 84 42 CFR Ch. I (10–1–19 Edition)
84.2 Definitions.
84.3 Respirators for mine rescue or other emergency use in mines.

 Subpart B—Application for Approval
84.10 Application procedures.
84.11 Contents of application.
84.12 Delivery of respirators and components by applicant; requirements.
Subpart K—Non-Powered Air-Purifying Particulate Respirators
84.170 Non-powered air-purifying particulate respirators; description.
84.171 Non-powered air-purifying particulate respirators; required components.
84.172 Breathing tubes; minimum requirements.
84.173 Harnesses; installation and construction; minimum requirements.
84.174 Respirator containers; minimum requirements.
84.175 Half-mask facepieces, full facepieces, hoods, helmets, and mouthpieces; fit; minimum requirements.
84.176 Facepieces, hoods, and helmets; eyepieces; minimum requirements.
84.177 Inhalation and exhalation valves; minimum requirements.
84.178 Head harnesses; minimum requirements.
84.179 Non-powered air-purifying particulate respirators; filter identification.
84.180 Airflow resistance tests.
84.181 Non-powered air-purifying particulate filter efficiency level determination.
84.182 Exhalation valve leakage test; minimum requirements.

84.1 Purpose.

The purpose of the regulations contained in this part 84 is:
(a) To establish procedures and prescribe requirements which must be met in filing applications for approval by 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.

§ 84.2 Definitions.
As used in this part—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.
Approval means a certificate or formal document issued by the Institute stating that an individual respirator or combination of respirators has met the minimum requirements of this part,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.
Approved means conforming to the minimum requirements of this part.
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 freshair
base.
Compressed-breathing gas means oxygen or air stored in a compressed state and supplied to the wearer in gaseous form.
dBA means sound pressure levels in decibels, as measured with the Aweighted network of a standard sound level meter using slow response. Dust means a solid mechanically produced particle with a size ranging from submicroscopic to macroscopic.
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.
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.
Fume means a solid condensation particle,generally less than 1 micrometer in diameter.
Gas means an aeriform fluid which is in a gaseous state at ordinary temperature and pressure.
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.
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.
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. Incoming inspection means the activity of receiving, examining, and accepting only those materials and parts whose quality conforms to specification requirements.
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.
Institute or NIOSH means the National Institute for Occupational Safety and Health, Department of Health and Human Services.
Liquefied-breathing gas means oxygen or air stored in liquid form and supplied to the wearer in a gaseous form. Mist means a liquid condensation particle with a size ranging from submicroscopic to macroscopic.
MSHA means the Mine Safety and Health Administration, U.S. Department of Labor.
National Personal Protective Technology Laboratory (NPPTL) means the National Personal Protective Technology Laboratory, National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention, Department of Health and Human Services, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236. NPPTL administers the NIOSH conformity assessment program for respiratory protective devices, replacing the former Certification and Quality Assurance Branch within the Division of Safety Research, Appalachian
Laboratory for Occupational Safety and Health, NIOSH. 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. 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).FTI. 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. Respirator means any device designed to provide the wearer with respiratory protection against inhalation of a hazardous
atmosphere.
Respirators for entry into and escape from means respiratory devices providing protection during entry into and escape from hazardous atmospheres. Respirators for escape only means respiratory devices providing protection only during escape from hazardous
atmospheres.(Single-use respirator means a respirator that is entirely discarded after excessive resistance, sorbent exhaustion, or physical damage renders it unsuitable for further use. Vapor means the gaseous state of a substance that is solid or liquid at ordinary temperature and pressure.
[60 FR 30355, June 8, 1995, as amended at 80  FR 3906, Jan. 26, 2015]
§ 84.3 Respirators for mine rescue or other emergency use in mines.
(a)(1) NIOSH and the Mine Safety and Health Administration (MSHA), U.S. Department of Labor, shall jointly review and issue certifications for respirators used for mine emergencies and mine rescue, including any associated service-life plans, users’ manuals and other supporting documentation.
(2) Each certification for a respirator designed for mine rescue or other

emergency use in mines shall include, as a condition of approval, any use limitations related to mine safety and health.
(b) NIOSH and MSHA shall jointly determine appropriate recall and retrofit remedies for field complaints o ridentified deficiencies involving any respirators used in the mining environment.

Subpart B—Application for Approval
§ 84.10 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 by the Institute only pursuant to written applications which meet the minimum requirements set forth in this subpart B.
(b) Applications must be submitted in accordance with the Standard Application

Procedure for the Certification of Respirators under 42 CFR 84, (Standard Application Procedure) available on the NPPTL Web site, to Records Room, National Personal Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236.
 (c) Except as provided in § 84.64, the examination, inspection, and testing of all respirators will be conducted or caused to be conducted by the National Personal Protective Technology Laboratory.
(d) Applicants, manufacturers, or their representatives may visit or communicate with the National Personal Protective Technology Laboratory in order to discuss the requirements for approval of any respirator or the proposed designs thereof. No charge will be made for such consultation and no written report will 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.[60 FR 30355, June 8, 1995, as amended at 80
FR 3906, Jan. 26, 2015]
§ 84.11 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 constructionof 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.
(The information collections contained in this section are approved under OMB control number 0920–0109)
 § 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 will deliver, at his or her own expense, the number of
completely assembled respirators and component parts required for their examination,inspection, and testing, to the National Personal Protective Technology Laboratory.

(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.
[60 FR 30355, June 8, 1995, as amended at 80 FR 3906, Jan. 26, 2015]

Subpart K—Non-Powered Air-Purifying Particulate Respirators
§ 84.170 Non-powered air-purifying particulate respirators; description.
(a) Non-powered air-purifying particulate respirators utilize the wearer’s negative inhalation pressure to draw the ambient air through the air-purifying filter elements (filters) to remove particulates from the ambient air. They are designed for use as respiratory protection against atmospheres with particulate contaminants (e.g., dusts, fumes, mists) that are not immediately dangerous to life or health and that contain adequate oxygen to support life.
(b) Non-powered air-purifying particulate respirators are classified into
three series, N-, R-, and P-series. The N-series filters are restricted to use in those workplaces free of oil aerosols.
The R- and P-series filters are intended for removal of any particulate that includes oil-based liquid particulates.
(c) Non-powered air-purifying particulate respirators are classified according to the efficiency level of the filter(s) as tested according to the requirements of this part.
(1) N100, R100, and P100 filters shall demonstrate a minimum efficiency level of 99.97 percent.
(2) N99, R99, and P99 filters shall demonstrate a minimum efficiency
level of 99 percent.
(3) N95, R95, and P95 filters shall demonstrate a minimum efficiency
level of 95 percent.
§ 84.171 Non-powered air-purifying particulate respirators; required
components.
(a) Each non-powered air-purifying particulate respirator described in
§ 84.170 shall, where its design requires,contain the following component parts:

(1) Facepiece, mouthpiece with noseclip,hood, or helmet;
(2) Filter unit;
(3) Harness;
(4) Attached blower; and
(5) Breathing tube.
(b) The components of each non-powered air-purifying particulate respirator shall meet the minimum construction requirements set forth in subpart G of this part.
§ 84.172 Breathing tubes; minimum requirements.
Flexible breathing tubes used in conjunction with respirators shall be designed and constructed to prevent:
(a) Restriction of free head movement;
(b) Disturbance of the fit of facepieces, mouthpieces, hoods, or helmets;
(c) Interference with the wearer’s activities;
and
(d) Shutoff of airflow due to kinking, or from chin or arm pressure.
§ 84.173 Harnesses; installation and construction; minimum requirements.
(a) Each respirator shall, where necessary,be equipped with a suitable harness designed and constructed to hold the components of the respirator in position against the wearer’s body.
(b) Harnesses shall be designed and constructed to permit easy removal and replacement of respirator parts,and, where applicable, provide for holding a full facepiece in the ready position when not in use.
§ 84.174 Respirator containers; minimum requirements.
(a) Except as provided in paragraph
(b) of this section each respirator shall be equipped with a substantial, durable container bearing markings which show the applicant’s name, the type of respirator it contains, and all appropriate approval labels.
(b) Containers for single-use respirators may provide for storage of
more than one respirator, however, such containers shall be designed and constructed to prevent contamination of respirators which are not removed, and to prevent damage to respirators during transit.

§ 84.175 Half-mask facepieces, full facepieces, hoods, helmets, and
mouthpieces; fit; minimum requirements.
(a) Half-mask facepieces and full facepieces shall be designed and constructed to fit persons with various facial shapes and sizes either:
(1) By providing more than one facepiece size; or
(2) By providing one facepiece size which will fit varying facial shapes and sizes.
(b) Full facepieces shall provide for optional use of corrective spectacles or lenses, which shall not reduce the respiratory protective qualities of the respirator.
(c) Hoods and helmets shall be designed and constructed to fit persons with various head sizes, provide for the optional use of corrective spectacles or lenses, and insure against any restriction of movement by the wearer.
(d) Mouthpieces shall be equipped with noseclips which are securely attached to the mouthpiece or respirator and provide an airtight seal.
(e) Facepieces, hoods, and helmets shall be designed to prevent eyepiece fogging.
(f) Half-mask facepieces shall not interfere with the fit of common industrial safety corrective spectacles.
§ 84.176 Facepieces, hoods, and helmets; eyepieces; minimum requirements.
Facepieces, hoods, and helmets shall be designed and constructed to provide adequate vision which is not distorted by the eyepieces.
§ 84.177 Inhalation and exhalation valves; minimum requirements.
(a) Inhalation and exhalation valves shall be protected against distortion.
(b) Inhalation valves shall be designed and constructed and provided
where necessary to prevent excessive exhaled air from adversely affecting filters, except where filters are specifically designed to resist moisture.
(c) Exhalation valves shall be:
(1) Provided where necessary;
(2) Protected against damage and external influence; and

(3) Designed and constructed to prevent inward leakage of contaminated air.
§ 84.178 Head harnesses; minimum requirements.
(a) All facepieces shall be equipped with head harnesses designed and constructed to provide adequate tension during use and an even distribution of pressure over the entire area in contact with the face.
(b) Facepiece head harnesses, except those employed on single-use respirators, shall be adjustable and replaceable.
(c) Mouthpieces shall be equipped, where applicable, with adjustable and replaceable harnesses, designed and constructed to hold the mouthpiece in place.
 § 84.179 Non-powered air-purifying particulate respirators; filter identification.
(a) The respirator manufacturer, as part of the application for certification,shall specify the filter series and the filter efficiency level (i.e.,
‘‘N95’’, ‘‘R95, ‘‘P95’’, ‘‘N99, ‘‘R99’’,‘‘P99’’, ‘‘N100’’, ‘‘R100’’, or ‘‘P100’’) for
which certification is being sought.
(b) Filters shall be prominently labeled
as follows:
(1) N100 filters shall be labeled ‘‘N100 Particulate Filter (99.97% filter efficiency level)’’ and shall be a color other than magenta.
(2) R100 filters shall be labeled ‘‘R100 Particulate Filter (99.97% filter efficiency level)’’ and shall be a color other than magenta.
(3) P100 filters shall be labeled ‘‘P100 Particulate Filter (99.97% filter efficiency level)’’ and shall be color coded magenta.
(4) N99 filters shall be labeled ‘‘N99 Particulate Filter (99% filter efficiency level)’’ and shall be a color other than magenta.
(5) R99 filters shall be labeled ‘‘R99 Particulate Filter (99% filter efficiency level)’’ and shall be a color other than magenta.
(6) P99 filters shall be labeled ‘‘P99 Particulate Filter (99% filter efficiency level)’’ and shall be a color other than magenta.

(7) N95 filters shall be labeled as ‘‘N95 Particulate Filter (95% filter efficiency level)’’ and shall be a color other than magenta.
(8) R95 filters shall be labeled as ‘‘R95 Particulate Filter (95% filter efficiency level)’’ and shall be a color other than magenta.
(9) P95 filters shall be labeled as ‘‘P95 Particulate Filter (95% filter efficiency level)’’ and shall be a color other than magenta.
§ 84.180 Airflow resistance tests.
(a) Resistance to airflow will be measured in the facepiece, mouthpiece, hood, or helmet of a particulate respirator (complete respirator) mounted on a test fixture with air flowing at continuous rate of 85 ±2 liters per minute, before each test conducted in accordance with § 84.182.
(b) The resistances for particulate respirators upon initial inhalation
shall not exceed 35 mm water column height pressure and upon initial exhalation shall not exceed 25 mm water column height pressure.
§ 84.181 Non-powered air-purifying particulate filter efficiency level determination.
(a) Twenty filters of each non-powered air-purifying particulate respirator model shall be tested for filter efficiency against:
(1) A solid sodium chloride particulate aerosol as per this section, if N-series certification is requested by the applicant.
(2) A dioctyl phthalate or equivalent liquid particulate aerosol as per this section, if R-series or P-series certification is requested by the applicant.
(b) Filters including holders and gaskets; when separable, shall be tested for filter efficiency level, as mounted on a test fixture in the manner as used on the respirator.
(c) Prior to filter efficiency testing of 20 N-series filters, the 20 to be tested shall be taken out of their packaging and placed in an environment of 85 ±5 percent relative humidity at 38 ±2.5 °C for 25 ±1 hours. Following the pre-conditioning, filters shall be sealed in a gas-tight container and tested within 10 hours.

(d) When the filters do not have separable holders and gaskets, the exhalation valves shall be blocked so as to ensure that leakage, if present, is not included in the filter efficiency level evaluation.
(e) For non-powered air-purifying particulate respirators with a single
filter, filters shall be tested at a continuous airflow rate of 85 ±4 liters per minute. Where filters are to be used in pairs, the test-aerosol airflow rate shall be 42.5 ±2 liters per minute through each filter.
(f) Filter efficiency test aerosols. (1) When testing N-series filters, a sodium chloride or equivalent solid aerosol at 25 ±5 °C and relative humidity of 30 ±10 percent that has been neutralized to the Boltzmann equilibrium state shall be used. Each filter shall be challenged with a concentration not exceeding 200mg/m3.
(2) When testing R-series and P-series filters, a neat cold-nebulized dioctyl phthalate (DOP) or equivalent aerosol at 25 ±5 °C that has been neutralized to the Boltzmann equilibrium state shall be used. Each filter shall be challenged with a concentration not exceeding 200
mg/m3.
(3) The test shall continue until minimum efficiency is achieved or until an aerosol mass of at least 200 ±5 mg has contacted the filter. For P-series filters, if the filter efficiency is decreasing when the 200 ±5 mg challenge point is reached, the test shall be continued until there is no further decrease in efficiency.
(g) The sodium chloride test aerosol shall have a particle size distribution with count median diameter of 0.075 ±0.020 micrometer and a standard geometricdeviation not exceeding 1.86 at the specified test conditions as determined with a scanning mobility particle sizer or equivalent. The DOP aerosol shall have a particle size distribution
with count median diameter of 0.185 ±0.020 micrometer and a standard geometric deviation not exceeding 1.60 at the specified test conditions as determined with a scanning mobility particle sizer or equivalent.
(h) The efficiency of the filter shall be monitored and recorded throughout the test period by a suitable forward forwardlight-scattering photometer or equivalent instrumentation.
(i) The minimum efficiency for each of the 20 filters shall be determined and recorded and be equal to or greater than the filter efficiency criterion listed for each level as follows:
P100, R100 and N100: Efficiency ≥99.97%
P99, R99 and N99: Efficiency ≥99%
P95, R95 and N95: Efficiency ≥95%
§ 84.182 Exhalation valve leakage test; minimum requirements.
(a) Dry exhalation valves and valve seats will be subjected to a suction of 25 mm. water-column height while in a normal operating position.
(b) Leakage between the valve and valve seat shall not exceed 30 milliliters per minute.