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DRAFT FOR DISCUSSION
1.0 Background In response to acts of terrorism and other natural disasters air-purifying
respirators are used to provide respiratory protection in work areas where
the hazards are known, characterized and conditions of oxygen deficiency
do not exist. Respirator use under these conditions must also be sufficient
to provide for contingency use in the event of a secondary device or if
additional unknown hazards are encountered exposing the responder to unexpected
hazards. In these unexpected situations, the air-purifying respirator
must be capable of delivering breathing protection as the responder escapes
from the area. Warm Zone: Area between hot and cold zones where personnel
and equipment decontamination and hot zone support take place. It includes
control points for the access corridor and thus assists in reducing the
spread of contamination. (2000 Emergency Response Guidebook, U.S. Department
of Transportation). It is also referred to as the contamination reduction
corridor (CRC, contamination reduction zone (CRZ), yellow zone or limited
access zone in other documents. (EPA Standard Operating Safety Guidelines,
OSHA 29 DFR 1920.120, NFPA 472).
The minimum filter canister capacity is defined using a test time of
15 minutes at gas concentrations based on three times immediately dangerous
to life or health (IDLH) concentration. The concept further allows stacking
additional protection for one or more of the 10 TRAs tested for a test
time of 30, 45, 60, 90 or 120 minutes. The additional specific TRAs are
identified by the manufacturer. It is also possible to specify one, none
or all 10 agent families at the greater capacity of 30, 45, 60, 90 or
120 minutes test time. 2.0 Purpose:Develop a NIOSH, NPPTL, powered air-purifying respirator standard that address Chemical Biological Radiological Nuclear (CBRN) materials identified as inhalation and/or possible terrorist hazards for emergency responders. The respirator must meet the minimum requirements identified in the following paragraphs:
3.0 Description:Powered air-purifying respirators use a powered mechanism to draw ambient air through an air-purifying filter elements(s) to remove contaminants from the ambient air. They are to be designed for use in atmospheres where the concentrations of contaminants during use are not immediately dangerous to life and health and contain adequate oxygen to support life; in addition, they may be used to escape from an unexpected IDLH condition provided there is adequate oxygen to support life. 3.1 Definitions:(a) Powered air-purifying respirator (PAPR) – an air-purifying respirator that uses a powered mechanism (blower) to pass ambient air through an air-purifying element to a respiratory inlet covering. (b) Tight fitting PAPR – a PAPR, which contains respiratory inlet covering that seals tightly to the face.
(d) Respiratory inlet covering –
A facepiece, hood, helmet or some combination of these, which serves as
the covering to the nose and mouth area and ensures that only purified
air reach these areas. 3.2 Respirator Use:A. Warm Zone/Cold Zone Use: Concentrations
above acceptable exposure limits, but less than IDLH concentrations, to
REL. Examples of use scenarios: sustained support operations; long term
use for decontamination, traffic control, rehabilitation, rescue and recovery;
agent known, quantified, and controlled. D. CBRN respirators contaminated with liquid chemical warfare agents are to be disposed of after the use in which they have been contaminated. 3.3 Hazards:NIOSH has been evaluating various lists of chemicals that could be deployed as a result of a terrorist incident. In earlier research during the development of the Chemical Biological Radiological Nuclear (CBRN) Air-Purifying Respirator (APR) Standard, NIOSH categorized potential respiratory hazards into families. Test representative agents identified for each family shall be the only agent tested for service life in that particular family, thus representing all the agents identified in the family. This effort was conducted in order to reduce the number of certification tests. Ten chemical TRAs, plus one particulate TRA, were identified. Testing against these 11 TRAs provides protection for 139 potential respiratory hazards. 4.0 Title 42 Code of Federal Regulations (CFR), Part 84:The following paragraphs of 42 CFR, Part 84 are applicable. 4.1 42 CFR, Part 84, Subparts A, B, D, E, F, and G: Subpart A. General Provisions 4.2 42 CFR, Part 84, Subpart KK: The following paragraphs apply: 84.1101 Definitions 5.0 Requirements Based on Existing National and International Standards:5.1 Respirator Containers; Minimum Requirements:5.1.1 CBRN PAPRs shall be equipped with a container bearing markings which show the applicant’s name and the type and commercial designation of the CBRN PAPR on all appropriate approval labels. 5.1.2 Containers for CBRN PAPRs shall be designed and constructed to permit easy removal of the respirator. 5.1.3. Required Packaging Configuration: Minimum packaging configuration: The PAPR and the required components shall be subjected to the environmental and transportation portions of the Durability Conditioning in the manufacturer specified Minimum Packaging Configuration. The canisters shall also be subjected to an additional Rough Handling Drop Test in its designated Minimum Packaging Configuration. The Minimum Packaging Configuration is the protective packaging configuration that the *end user shall store or maintain the PAPR and the required components inside after it has been issued for immediate use. The user’s instructions (UI) shall identify the Minimum Packaging Configuration and shall direct the end user how to store or maintain the PAPR and the required components inside the manufacturer specified Minimum Packaging Configuration while in the possession of the end user. The same Minimum Packaging Configuration identified in the UI shall encase the PAPR and the components when NIOSH performs the Durability Conditioning. The level of the Minimum Packaging Configuration, if any, is left to the discretion of the PAPR manufacturer. Examples of common Minimum Packaging Configurations are mask carriers, clamshell containers, drawl string plastic bags, hermetically sealed canister bags or nothing at all. If over cases, packaging, or shipping containers are provided by the applicant over and above the Minimum Packaging Configuration, these additional packaging levels may not be a substitute for the Minimum Packaging Configuration and will not be used by NIOSH in the Durability Conditioning of the application. * End user: The definition of
the end user is the person who will derive protection from the respirator
by wearing it. It is assumed that the end user will store the respirator
in a location where it will be available for immediate access and use
during an emergency 5.2 Labels:In addition to the requirements of Paragraph 4.2, the following paragraphs apply: 5.2.1 The battery part number must be prominently displayed with the part number on the respirator battery pack or other suitable location. 5.2.2 Additional cautions and limitations appropriate to
CBRN PAPRs must be added as deemed necessary by NIOSH, such as “Observe
low flow or pressure alarm indicators.” 5.3 General Construction Requirements:5.3.1 Battery Requirements: 5.3.1.1 The user’s instructions shall include the manufacturer’s operational battery life for all battery options for the respirator. The manufacturer specified battery service life will be used for Breathing Performance, Paragraph 5.4. The user’s instructions will also include descriptive information regarding the distinct warning for low battery indication at the fifteen minute warning. 5.3.1.2 Each CBRN PAPR must contain an indicator to show the state of charge of the battery. The indicator may be passive such as a tamper proof device installed indicating a fully charged battery condition along with an identified date for expiration of the fully charged condition and an indicator which alerts the user when 15 minutes of operational battery life remains.The indicator may also be an active indicator such as an illuminated light, which provides the same 15-minute remaining warning. The indicator must be capable of monitoring the battery conditions and signaling the user when the remaining operational battery life is sufficient to sustain the desired flow rate for at least 15 minutes but not more than 25 minutes. 5.3.1.3 User instructions shall prominently list the operational battery life for all available battery options and provide adequate information on the function and operation of battery charge. The user instructions shall also provide the specific indicator location and method of indication in a manor that the user can understand. 5.3.2 Low Flow Indicator: 5.3.2.1 Each CBRN PAPR shall have an indicator to alert the user when the airflow in the breathing zone reaches the applicant’s identified acceptable minimum flow for the respirator. 5.3.2.2 User instructions shall provide adequate information
on the function and operation of low flow and/or low pressure indicators
to insure proper use/attention/reaction to these indicators. 5.3.3 Operational Controls: CBRN PAPR units must be equipped with readily accessible switches and controls designed to prevent accidental shutoff. 5.4 Breathing Performance:5.4.1 Breathing Rate: Powered air-purifying respirators will be approved for breathing rate performance at either a moderate rate or a high rate as specified by the applicant. 5.4.2 Moderate Breathing Rate Performance: PAPRs designated for the moderate breathing rate will be tested using a breathing machine operating at 24 respirations per minute while delivering a minute volume of 40 L/min flow. A breathing machine with a Silverman Cam (6.22kg • m/min) will be used. The breathing machine is specified in 42 CFR, Part 84 subpart H, Paragraph 84.88. 5.4.3 High Breathing Rate Performance: PAPRs designated for the high breathing rate will be tested using a breathing machine operated at 30 respirations per minute while delivering a minute volume of 103 L/min. The breathing machine shall be as specified in the NFPA 1981, Open-Circuit Self-Contained Breathing Apparatus for Fire and Emergency Service, 2002 Edition, Table 8.1.4.10.7(a) Lung Breathing Waveforms for 103 L/min Volume Work Rate. 5.4.4 Breathing Performance Requirement: During operation of the breathing machine described in paragraphs 5.4.2 and 5.4.3., the PAPR shall be mounted on a manikin head equipped to continuously monitor pressure in the breathing zone of the respirator. During operation, the pressure shall be maintained greater than 0.0 and less than or equal to 3.5 inches water column pressure at all times for both inhalation and exhalation cycles of the breathing machine. 5.4.5 Breathing Performance Test Time: Breathing performance will be continuously recorded for the applicant specified operational battery life, plus 20 minutes. 5.5 Field of View:The CBRN PAPR Respiratory inlet covering shall obtain a
Visual Field Score (VFS) of 90 or greater. The VFS shall be obtained by
using a medium size respirator or equivalent that is sized to fit the
Head Form described in Figure 14 of EN 136, Respiratory protective devices
– Full face masks – Requirements, testing marking; January
1998 or equivalent. 5.6 Respiratory Inlet Covering: Lens Material Haze, Luminous Transmittance and Abrasion Resistance:5.6.1 Haze: The haze value of the primary lens material shall be 3% or less when tested in accordance with ASTM D 1003-00. 5.6.2 Luminous Transmittance: The luminous transmittance value of the primary lens material shall be 88% or greater when tested in accordance with ASTM D 1003-00. 5.6.3 Abrasion Resistance: The haze and luminous transmittance of the primary lens material shall be determined in accordance with ASTM D 1003-00 before and after subjecting the lens material to the abrasion test. The abrasion test shall be conducted in accordance with ASTM D 1044-99 using a CS-10F Taber calibrase wheel or equivalent at a minimum of 70 cycles under a 500-gram weight. After subjecting the lens material to the abrasion test, remove the residue from the test specimens in accordance with ASTM D 1044-99 or by using a cleaning method recommended by the applicant. After the residue is removed fro the test specimens, the test specimens shall not exhibit an increase of haze greater than 4% and a decrease of luminous transmittance greater than 4%. 5.6.4 Test Specimens: The test specimens shall be the flat 4-inch (102 mm) square version as prescribed in ASTM D 1044-99 and shall have the same nominal thickness and within the tolerance range as the primary lens’ dominant viewing area (Directly in front of the eyes) of the CBRN PAPR. The test specimens shall be subjected to the same coating process and any other processes, as the primary lens would be under normal production conditions. Six specimens shall be furnished to NIOSH for certification testing, three pre-abrasion specimens and three specimens after being tested for abrasion in accordance with ASTM D-1044-99. 5.7 Carbon Dioxide:The maximum allowable average inhaled carbon dioxide concentration shall be less than or equal to 1 percent, measured at the mouth, while the respirator is mounted on a dummy head operated by a breathing machine with the blower running. The breathing rate will be 14.5 respirations per minute with a minute volume of 10.5 liters. Tests will be conducted at ambient temperature of 25ºC ± 5ºC. A concentration of 5% carbon dioxide in air will be exhaled into the respiratory inlet covering. The minimum allowable oxygen concentration shall be 19.5%. 5.8 Hydration:For CBRN PAPR respirators equipped with a hydration facility, the CBRN PAPR respirator shall meet all requirements of the CBRN PAPR standard with the hydration facility in place. Dry drinking tube valves, valve seats, or seals will be subjected to a suction of 75mm water column height while in a normal operating position. Leakage between the valve and the valve seat shall not exceed 30 milliliters per minute. NIOSH Test Procedure RCT-APR-STP-0014 is used for hydration facility leakage. 5.9 Noise Levels:Noise levels generated by the PAPR measured at each ear location shall not exceed 75 dBA. In the case of inlet coverings that cover the ear, the noise level will be measured inside the inlet covering. 6.0 Special CBRN Requirements:6.1 Canister Test Challenge and Test Breakthrough Concentrations:The gas/vapor test challenges and breakthrough concentrations shown in Table 1: Canister Challenge, Breakthrough Concentrations, and Canister Efficiency shall be used to establish the canister service life: Table 1: Canister Test Challenge and Test Breakthrough Concentrations
* Sum of HCN and C2N2. 6.2 Canister Capacity:The applicant shall specify the canister capacity as indicated in Table 2: Table 2.—Canister capacity
Table 3.—Constant flow PAPR and demand responsive PAPR flow rates
Flow rates for Constant Flow PAPR system will be established
using a test procedure developed and conducted based on the existing procedure
RCT-APR-STP-0012. The canisters shall meet or exceed the specified test
times without exceeding the identified breakthrough concentrations in
Table 1. Canister capacity testing shall be performed following Durability
Conditioning described in paragraph 6.9. For PAPRs with a single filter
element, filters shall be tested at a continuous airflow rate determined
as specified in this paragraph. Where multiple filter elements are used,
the filter canister capacity airflow rate shall be reduced in proportion
to the number of filter elements. 6.3 Particulate/Aerosol Canister:The canister shall meet the requirements of 99.97% particulate filter efficiency in accordance with the following criteria. Particulate filter efficiency testing shall be performed following the Durability Conditioning. 6.3.1 Twenty (20) canisters shall be tested for filter efficiency against a dioctyl phthalate or equivalent liquid particulate aerosol. 6.3.1.1 Additionally, six (6) canisters from the cyclohexane gas life test of Paragraph 6.1 shall be tested for filter efficiency against dioctyl phthalate or equivalent liquid particulate aerosol. 6.3.2 Canisters 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. 6.3.3 When the canisters 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. 6.3.4 For PAPRs with a single canister element, the canister shall be tested at a continuous airflow rate determined as specified in Paragraph 6.2, Canister Capacity . Where multiple canisters are used, the test-aerosol airflow rate shall be reduced in proportion to the number of canisters. In lieu of efficiency tests at the determined flow rate, efficiency testing may be performed using test filters sized to produce an equivalent face velocity through the filter at a flow rate of 85 L/min. If efficiency testing with filters of reduced area is used twenty test filters and twenty production filters are required. The twenty production filters will be tested at 85 L/min flow to verify the effectiveness of the filter media to filter housing interface. If alternate testing procedures are used, media samples will be preconditioned with cyclohexane. 6.3.5 A neat cold-nebulized dioctyl phthalate (DOP) or equivalent aerosol at 25ºC ± 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. 6.3.6 The test shall continue until minimum efficiency is achieved or until an aerosol mass of at least 200 mg ± 5 mg challenge point is reached, the test shall be continued until there is no further decrease in efficiency. 6.3.7 The DOP aerosol shall have a particle size distribution with count median diameter of 0.185 µm ± 0.020 µm and a standard geometric deviation not exceeding 1.60 at the specified test conditions as determined with a scanning mobility particle sizer or equivalent. 6.3.8 The efficiency of the filter shall be monitored throughout the test period by a suitable forward-light-scattering photometer or equivalent instrumentation and recorded. 6.3.9 The minimum efficiency for each of the twenty filters shall be determined and recorded and be equal to or greater than 99.97%. 6.4 Crisis (Panic Demand) Provision:Constant Flow PAPR and Pressure Demand PAPR canister capacity shall be evaluated using a constant flow rate of 430 L/min for 5 minutes. The canisters shall not exceed the breakthrough times identified in Paragraph 6.1. 6.5 Low Temperature/Fogging:The CBRN PAPR respiratory inlet covering shall demonstrate and average Visual Acuity Score (VAS) of greater or equal to 75 points for all measurements of acuity with the blower operating. The respirator shall be cold soaked for 4 hours and then worn in an environmental chamber maintained at minus 21°C. 6.6 Communications:Communication requirements are based upon performance using a Modified Rhyme Test (MRT). The communications requirement is met if the overall performance rating is greater than or equal to seventy (70) percent. The MRT will be performed with a steady background noise of 60 dBA consisting of a broadBAnd “pink” noise with the blower operating. The distance between the listeners and speakers shall be 3 meters. 6.7 Chemical Agent Permeation and Penetration Resistance Against Distilled Sulfur Mustard (HD) and Sarin (GB) Agent Requirement: The air-purifying respirator system, including all components
and accessories shall resist the permeation and penetration of distilled
sulfur mustard (HD) and Sarin (GB) chemical agents when tested on an upper-torso
manikin connected to a breathing machine operating at an air flow rate
of 40 L/min, 36 respirations per minute, 1.1 liters tidal volume. Table 4.—Vapor-liquid sequential challenge of PAPR with distilled sulfur mustard (HD)
* Vapor challenge concentration will start immediately
after the test chamber has been sealed. Minimum Test Time for liquid exposure
starts after the first liquid drop is applied.
Test requirements for Sarin (GB) agent are shown in Table 5: Table 5: Vapor Challenge of APR with Sarin (GB)
* The vapor challenge concentration generation will be
initiated immediately after test chamber has been sealed. 6.8 Laboratory Respiratory Protection Level (LRPL) Test Requirement: The measured laboratory respiratory protection level (LRPL)
for each powered air-purifying respirator shall be 10,000 for = 95% of
trials with the blower operating. All sampling will be performed in the
breathing zone of the respirator. The respirator is tested in an atmosphere
containing 20–40 mg/m3 corn oil aerosol of a mass median aerodynamic
diameter of 0.4–0.6 µm. The LRPL shall be calculated using
eleven exercises: Normal Breathing, Deep Breathing, Turn Head Side to
Side, Move Head Up and Down, Recite the Rainbow Reading Passage or equivalent,
Sight a Mock Rifle, Reach for the Floor and Ceiling, On Hands and Knees
– Look Side to Side, Facial Grimace, Climb Stairs at a Regular Pace,
and Normal Breathing. Table 6. – Anthropometric test criteria for a 3 size configuration
*If applicable to design of PAPR. For each size category (Small, Medium, and Large), each
cell corresponding to the anthropometric parameter will be tested. Cells
can be either exclusively (if the test subjects only meet the requirements
of a specific cell) or concurrently (if the test subjects meet the requirements
of more than one cell) tested for each size category. User Instructions must clearly and accurately explain how users choose appropriate size. 6.9 Durability Conditioning:Durability Conditioning shall be performed in accordance with Table 7. Table 7: Durability Conditioning
Notes: Batteries may be recharged after conditioning if used for certification testing. Batteries Exposed to Durability Conditioning must not render
the PAPR in-operable and must result in self –reporting of functionality 6.10 Test Sequence:To Be Determined. 6.11 Quality Assurance Requirements:6.11.1 Quality Control Plan: Respirators submitted for CBRN powered air-purifying respirator approvals shall be accompanied by a complete quality control plan meeting the requirements of Subpart E of Title 42, Code of Federal Regulations (CFR), Part 84. 6.11.2 Sampling/Test/Inspection Plan: a). Materials of construction used for respirator parts
that form a barrier between the user and ambient air. 6.12 Practical Performance: The Practical Performance of the powered air-purifying
respirator shall be evaluated as part of the test procedures of paragraph
6.8, Laboratory Respirator Protection Level. The Practical Performance
of the respirator shall evaluate human interface issues associated with
the use of the respirator. As a minimum, factors which will be evaluated
(if applicable based upon the respirator design) are: the inability for
the user to accidentally turn the power switch off; and the inability
for hoses and electrical wires to tangle, causing the respirator position
on the wearer to move to an improper position, such as the respirator
facepiece or hood being removed from the wearer's head. Test subjects
shall be trained on proper use of the respirator in accordance with the
applicant’s user instructions.
6.13 General Requirements:In addition to the requirements of Title 42, Code of Federal Regulations (CFR), Subpart G – General Construction and Performance Requirements, the following requirements apply: Prior to making or filing any application for approval or modification of approval, the applicant shall conduct, or cause to be conducted, examinations, inspections, and tests of respirator performance, which are equal to or exceed the severity of those prescribed in the standard. Paragraph 6.7 Systems Tests are excluded from this requirement. 6.14 Cautions and Limitations:To Be Determined
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