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DRAFT FOR DISCUSSION
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 CBRN PAPR must meet the following minimum requirements:
(a) Approval under NIOSH 42 CFR Part 84
(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 – CBRN tight-fitting
PAPR
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 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 level
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
2.0 Chemical 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, 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. Chemical agent permeation and penetration
resistance testing shall be performed on four PAPR (two for HD and two
for GB) following the durability conditioning.
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/m 3 ) |
Number
Of
Systems
Tested |
Minimum
Test Time
(hours) |
HD-
Vapor |
50 mg/m 3* |
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 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/m 3 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 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/m 3 ) |
Maximum
Breakthrough
(concentration
integrated over
minimum test time)
(mg-min/m 3 ) |
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/m 3 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). All sampling will be performed
in the breathing zone of the respirator. The respirator is tested in
an atmosphere containing 20–40 mg/m 3 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. All sampling
will be performed in the breathing zone of the respirator. The respirator
is tested in an atmosphere containing 20–40 mg/m 3 corn oil aerosol of
a mass median aerodynamic diameter of 0.4–0.6 µm.
4.0 Canister Test Challenge and Test Breakthrough Concentrations– Reference
STPs CBRN – 0501, 0502, 0503, 0504, 0505, 0506, 0507, 0508, 0509, 0510)
4.1 Tight-fitting facepiece
4.1.1 The gas/vapor test challenges and breakthrough concentrations
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 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 NO 2 or 25 ppm NO † |
Phosgene |
250 |
1.25 |
Phosphine |
300 |
0.3 |
Sulfur dioxide |
1,500 |
5 |
* Sum of HCN and C 2 N 2
† Nitrogen Dioxide breakthrough is monitored for
both NO 2 and NO. The breakthrough is determined by which quantity,
NO 2 or NO, reaches breakthrough first.
4.2 Loose-fitting facepiece
4.2.1 The gas/vapor test challenges and breakthrough concentrations
shown in Table 5. 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 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 NO 2 or 25 ppm NO † |
Phosgene |
125 |
1.25 |
Phosphine |
150 |
0.3 |
Sulfur dioxide |
750 |
5 |
* Sum of HCN and C 2 N 2
† Nitrogen Dioxide breakthrough is monitored for
both NO 2 and NO. The breakthrough is determined by which quantity,
NO 2 or NO, reaches breakthrough first.
4.3 Particulate/aerosol testing
4.3.1 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.
4.3.2 Twenty (20) canisters shall be tested for filter efficiency
against a dioctyl phthalate or equivalent liquid particulate aerosol
4.3.2.1 Additionally, six canisters 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 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 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 Canister particulate testing for the system will be tested
at a flow rate of 170 Lpm divided by the least number of canisters
used on the loose-fitting 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 shall be challenged with a concentration not exceeding 200
mg/m 3
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 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 approvals have been issued for 42 CFR Part 84 approval 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 them for upgrading to CBRN capability
5.2 Retrofit of previously approved 42 CFR Part 84 and CBRN tight-fitting
PAPR must be performed by manufacturer-trained and authorized technicians,
who ensure the retrofit complies with the approved CBRN PAPR configuration,
quality assurance and performance requirements
5.3 The CBRN PAPR retrofit kit must, as a minimum, contain the following:
- CBRN PAPR retrofit kit instructions
- Replacement packaging, components, parts, materials, and operation
instructions required to retrofit the PAPR configuration to the approved
CBRN configuration level
- 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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