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These concepts are being discussed as a means to approve CBRN PAPR
and subsequently upgrade existing 42 CFR Part 84 approved PAPRs to CBRN
standards.
Since the introductions of the CBRN PAPR concept, manufacturers and
users have expressed the desire and need to have CBRN PAPRs available
and to upgrade existing 42 CFR Part 84 approved PAPRs to CBRN standards
as soon as possible.
The CBRN PAPR and CBRN PAPR retrofit capability should increase the
number of emergency responders afforded protection by NIOSH-approved
CBRN respirators.
The CBRN PAPR approval process is essentially conducted in two stages.
The first stage requires 42 CFR Part 84 approval. Following 42 CFR Part
84 approval, the manufacturer may apply for CBRN PAPR approval. Following
both 42 CFR Part 84 approval and CBRN PAPR approval, manufacturers may
continue to a third stage and seek approval for CBRN PAPR retrofit kits.
The 42 CFR Part 84 approval process remains unchanged. The CBRN PAPR
special test requirements are described in paragraphs 1.0 through 4.3.10
below. The CBRN PAPR retrofit requirements are described
in the section 5.0.
The Chemical, Biological, Radiological, and Nuclear (CBRN) Powered Air-Purifying
Respirator (PAPR) must meet the following minimum performance requirements:
(a) PAPR performance criteria from NIOSH 42 CFR Part 84, to include
as applicable:
Test # |
Title |
1 |
Initial DOP -- HE protection (if applicable) |
3 |
Exhalation resistance with blower off (tight fitting) |
4 |
Exhalation valve leakage (if applicable) |
5/5A/6 |
IAA fit test |
7 |
Inhalation resistance with blower off (tight fitting) |
12 |
PAPR Air Flow* |
25 |
Silica Dust+ |
30 |
Sound Level (if applicable) |
33-48 or 62 |
Gas and Vapor (as applicable) |
60 |
ESLI visibility (if applicable) |
61 |
ESLI damage resistance (if applicable) |
* 115 liters per min (Lpm) for
tight-fitting, 170 Lpm for loose-fitting
+ CBRN Canister/Cartridge
evaluated in Silica Dust test |
(b) Special tests under NIOSH 42 CFR Part 84.63(c)
(1) Durability conditioning
(2) Chemical agent permeation and penetration resistance against
Distilled Sulfur Mustard (HD) and Sarin (GB)
(3) Laboratory Respirator Protection Level (LRPL)
(4) Canister test challenge and test breakthrough concentrations
1.0 Durability conditioning (CBRN tight-fitting PAPR only) (Reference STP CBRN-
0311)
1.1 Respirator containers; minimum requirements
1.1.1 Required packaging configuration: (minimum packaging configuration):
The CBRN tight-fitting 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.
1.1.2 The minimum packaging configuration is the protective packaging
configuration that the end user* shall store or maintain the CBRN
tight-fitting 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 CBRN tight-fitting 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 CBRN tight-fitting PAPR and the components when NIOSH
performs the durability conditioning. The type of the minimum packaging
configuration, if any, is left to the discretion of the manufacturer.
Examples of common minimum packaging configurations are mask carriers,
clamshell containers, draw 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.
1.2 Durability conditioning shall be performed in accordance
with Table 1
Table 1 — Durability conditioning
Test |
Test Method |
Test Condition |
Duration |
Hot Diurnal |
Mil-Std-810F; Method
501.4; Table 501.4-II; Hot-Induced Conditions |
Diurnal Cycle, 35° C
(95° F) to 71° C (160° F) |
3 Weeks |
Cold Constant |
Mil-Std-801F, Method
502.4; |
Basic Cold (C1), -32° C
-25.6° F); Constant |
72 Hours |
Humidity |
Mil-Std-810E, 507.3;
Method 507.3; Table 507.3-II |
Natural Cycle, Cycle
1, Diurnal Cycle, 31° C (88°F) RH 88% to 41° C (105° F)
RH 59% |
5 Days, Quick Look |
Vibration |
Mil-Std-810F, 514.5 |
U.S. Highway Vibration,
Unrestrained
Figure 514.5C-1
|
12 Hours/Axis, 3 Axis;
Total Duration = 36
Hours, equivalent to 12,000 miles
|
Drop |
3 foot drop onto bare
concrete surface |
Canister only; In individual
canister packaging container |
1 drop/filter on one
of the 3 axes. |
1.3 Extra batteries (not subjected to the durability conditioning)
are required for certification testing
2.0Chemical Agent Permeation and Penetration Resistance against
Distilled Sulfur Mustard (HD) and Sarin (GB) Agent Requirement - (Reference
STPs CBRN - 0550 and 0551)
2.1 The PAPR, while the blower is running and including all components
and accessories except for the battery (or batteries), 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 airflow rate of 40 L/min, 36
respirations per minute, and 1.1 liters tidal volume. Test requirements
for distilled sulfur mustard (HD) are shown in Table 2. Test
requirements for Sarin (GB) agent are shown in Table 3. For tight-fitting
PAPRS, two systems will be used for preliminary screening. Chemical
agent permeation and penetration resistance testing shall be performed
on four tight-fitting PAPRS (two for HD and two for GB) following the
durability conditioning of Paragraph 1.0.
Table 2 —Vapor-liquid sequential
challenge with distilled sulfur mustard (HD)
Agent |
Challenge
Concentration |
Duration
Of Challenge (min) |
Breathing
Machine
Airflow
Rate
(L/min) |
Maximum
Peak
Excursion
(mg/m 3 ) |
Maximum
Breakthrough
(concentration
integrated over
minimum test time)
(mg-min/m3 ) |
Number
Of
Systems
Tested |
Minimum
Test Time
(hours) |
HD-
Vapor |
50 mg/m3* |
30* |
40 |
0.30‡ |
3.0§ |
3 |
8†† |
HD-
Liquid |
0.43 to 0.86
ml *,†,** |
120* |
40 |
0.30‡ |
3.0‡ |
3 |
2 |
*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.
†Liquid Volume is dependent
on accessories used with the respirator. Minimum volume is 0.43 ml
based on the respirator only. Liquid challenge required on CBRN
tight-fitting PAPRs only.
‡Three consecutive sequential
test data points at or exceeding 0.3 mg/m3 will collectively
constitute a failure where each test value is based on a detector sample
time of approximately two (2) minutes.
§The cumulative Ct including
all maximum peak excursion data points must not be exceeded for the
duration of the test.
**Liquid agent is applied to respirator
at hour six (6) of the vapor test cycle.
††The test period begins upon the initial
generation of vapor concentration and ends at eight (8) hours. Supplemental
electrical power to the PAPR is permissible to allow the system to
run for the purpose of this test..
Table 3—Vapor challenge with Sarin (GB)
Agent |
Challenge
Concentration |
Duration
Of Challenge (min) |
Breathing
Machine
Airflow
Rate
(L/min) |
Maximum
Peak
Excursion
(mg/m3 ) |
Maximum
Breakthrough
(concentration
integrated over
minimum test time)
(mg-min/m3 ) |
Number
Of
Systems
Tested |
Minimum
Test Time
(hours) |
GB |
210* |
30* |
40 |
0.044‡ |
1.05§ |
3 |
8†† |
*The vapor challenge concentration generation will
be initiated immediately after test chamber has been sealed
†The test period begins upon initial generation of
vapor concentration and ends at 8 hours. Supplemental electrical power
to the PAPR is permissible to allow the system to run for the purpose
of this test
‡Three consecutive sequential test data points at or
exceeding 0.044 mg/m3 will collectively constitute a failure where
each test value is based on a detector sample time of approximately
2 minutes
§The cumulative Ct including all maximum peak
excursion data points must not be exceeded for the duration of the
test
3.0 Laboratory Respiratory Protection Level
(LRPL) Test Requirement – (all Respirators, Reference STP CBRN
0552)
3.1 The measured laboratory respiratory protection
level (LRPL) for each powered, air-purifying respirator shall be 10,000
for > 95% trials with the blower operating (blower on mode).
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.
3.2 The measured laboratory respiratory protection
level (LRPL) for each tight-fitting powered, air-purifying
respirator shall be 2,000 for > 95% trials with the blower
not operating (Blower Off mode). A modified LRPL using a sample size
of 8 subjects will be used for evaluation. 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.
3.3 This test will be performed with the PAPR fully
accessorized with any components identified in the assembly matrix
and submitted for certification.
4.0 Canister and Cartridge Test Challenge and Test Breakthrough
Concentrations– Reference STPs CBRN – 0501, 0502, 0503,
0504, 0505, 0506, 0507, 0508, 0509, 0510)
4.1 Canisters (tight-fitting PAPR)
4.1.1 The gas/vapor test challenges and breakthrough
concentrations are shown in Table 4. Canister capacity tests will
be performed at room temperature, 25 ºC ± 2.5 °C;
and at 25% ± 2.5% relative humidity and 80% ± 2.5% relative
humidity. Three canisters will be tested at each specified humidity.
Canister test time is fifteen minutes. Canister capacity testing for
the system will be tested at a flow rate of 115 Lpm divided by the
least number of canisters used on any configuration of the system
for which approval is sought. Canister capacity testing shall
be performed following the durability conditioning.
Table 4 —Canister test challenge and test breakthrough
concentrations
|
Test Concentration (ppm) |
Breakthrough Concentration
(ppm) |
Ammonia |
2,500 |
12.5 |
Cyanogen chloride |
300 |
2 |
Cyclohexane |
2,600 |
10 |
Formaldehyde |
500 |
1 |
Hydrogen cyanide |
940 |
4.7* |
Hydrogen sulfide |
1,000 |
5.0 |
Nitrogen Dioxide |
200 |
1 ppm NO2 or 25 ppm NO† |
Phosgene |
250 |
1.25 |
Phosphine |
300 |
0.3 |
Sulfur dioxide |
1,500 |
5 |
*Sum of HCN and C2 N2
†Nitrogen Dioxide breakthrough is
monitored for both NO2 and NO. The breakthrough is determined
by which quantity, NO2 or NO, reaches breakthrough first.
4.2 Cartridges (loose-fitting PAPR)
4.2.1 The gas/vapor test challenges and breakthrough
concentrations are shown in Table 5. Cartridge capacity tests will
be performed at room temperature, 25 ºC ± 2.5 °C;
and at 25% ± 2.5% relative humidity and 80% ± 2.5%
relative humidity. Three cartridges will be tested at each specified
humidity. Cartridge test time is fifteen minutes. Cartridge capacity
testing for the system will be tested at a flow rate of 170 Lpm divided
by the least number of canisters used on the system for which approval
is sought.
Table 5 —Canister test challenge and test
breakthrough concentrations
|
Test Concentration (ppm) |
Breakthrough Concentration
(ppm) |
Ammonia |
1,250 |
12.5 |
Cyanogen chloride |
150 |
2 |
Cyclohexane |
1,300 |
10 |
Formaldehyde |
250 |
1 |
Hydrogen cyanide |
470 |
4.7* |
Hydrogen sulfide |
500 |
5.0 |
Nitrogen Dioxide |
100 |
1 ppm NO2 or 25 ppm NO† |
Phosgene |
125 |
1.25 |
Phosphine |
150 |
0.3 |
Sulfur dioxide |
750 |
5 |
*Sum of HCN and C2 N2
†Nitrogen Dioxide breakthrough is
monitored for both NO2 and NO. The breakthrough is determined
by which quantity, NO2 or NO, reaches breakthrough first.
4.3 Particulate/aerosol testing
4.3.1 The canister/cartridge 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.
4.3.2 Twenty (20) canisters/cartridges shall be
tested for filter efficiency against a dioctyl phthalate or equivalent
liquid particulate aerosol
4.3.2.1 Additionally, six canisters/cartridges
from the cyclohexane gas life test of paragraphs 4.1 and 4.2 shall
be tested for filter efficiency against dioctyl phthalate or equivalent
liquid particulate aerosol.
4.3.3 The canister/cartridge 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
4.3.4 When the canister/cartridge does not have
separable holders and gaskets, the exhalation valves shall be blocked
to ensure that leakage, if present, is not included in the filter
efficiency level evaluation
4.3.5 Cartridge particulate testing for loose-fitting
PAPR systems will be tested at a flow rate of 170 Lpm divided by
the least number of cartridges used on the system for which approval
is sought. Canister particulate testing for the tight-fitting
system will be tested at a flow rate of 115 Lpm divided by the least
number of canisters used on the system for which approval is sought
4.3.6 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
canister/cartridge shall be challenged with a concentration not exceeding
200 mg/m3
4.3.7 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
4.3.8 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
4.3.9 The efficiency of the canister/cartridge
shall be monitored throughout the test period by a suitable forward-light-scattering
photometer or equivalent instrumentation and recorded
4.3.10 Current test technology limits flow rate
testing to 95 Lpm. When test equipment has been validated to
test at higher flows, single filter elements will be able to be evaluated..
5.0
CBRN PAPR Upgrade Retrofit
Once the system(s) has met the requirements for 42 CFR Part 84 and subsequent
CBRN PAPR approval, manufacturers may apply for approval of CBRN PAPR
retrofit kits to upgrade existing 42 CFR Part 84 PAPR to CBRN PAPR standards. In
doing so, the following applies:
5.1 PAPR units must be 42 CFR Part 84 and CBRN PAPR
approved prior to submitting an application for upgrading to
CBRN capability
5.2 Retrofit of previously approved 42 CFR Part 84
and CBRN tight-fitting PAPR must be performed in accordance with manufacturer
instructions, to ensure the retrofit complies with the approved CBRN
PAPR configuration, quality assurance and performance requirements
5.3The CBRN PAPR retrofit kit must, as a minimum,
contain the following:
- CBRN PAPR retrofit kit instructions
- Replacement packaging, components, parts, materials, CBRN canisters
or cartridges (as applicable) and operation instructions required
to retrofit the PAPR to the identical configuration as the approved
CBRN configuration level (including minimum packaging configuration)
- Registration materials for recording PAPR info rmation as required
by the manufacturer to track specific units that have been updated
- CBRN PAPR retrofit approval label(s) for the respirator retrofit
kit
- Respirators which are to be retrofitted must be in “fully
operational and protective condition”
5.4 Manufacturers will need to submit a Standard
Application Form and associated documents which clearly define the
respirators eligibility for retrofit and explain the configuration
changes achieved with the retrofit kit
5.5 The manufacturer must provide four PAPRs which
have been in service for one to five years. As a minimum, submitted
respirators are to be from two different conditions of use: Two from
a light condition of use category. Light use is defined as a PAPR primarily
in a storage configuration; used intermittently throughout the service
life. Two from a heavy condition of use category. Heavy use is
defined as PAPR used routinely for respiratory protection as part of
an OSHA-compliant respirator program.
5.6 The units should be supplied with the retrofit
kit installed
5.7 NIOSH testing performed on the respirators will
be evaluated to the special tests for chemical agent permeation and
penetration resistance against Distilled Mustard (HD) and Sarin (GB)
for each respirator use condition provided plus any other tests described
above or as deemed necessary by NIOSH
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