Determination Of Laboratory Respirator Protection Level (LRPL) Quantitative,
Medium Flow, Deep Probe, Corn Oil, Fit Factor Performance Test For Chemical,
Biological, Radiological And Nuclear (CBRN) Full Facepiece Respiratory
Protective Devices (RPD) Standard Testing Procedure (STP)
1. PURPOSE:
1.1. The test establishes procedures for ensuring a specific level of
respiratory protection provided by Chemical, Biological, Radiological,
and Nuclear (CBRN) Full Facepeice Respiratory Protective Devices (RPD)
requirements meet the minimum certification standards set forth in this
Standard Test Procedure (STP) as prescribed in 42 CFR, Part 84, Subpart
G, Section 84.63(a)(c)&(d); Federal Register, Volume 60, Number 110,
June 8, 1995 after being submitted as a new approval application, extension
of approval application, or examined during certified product audits.
1.2 The scope of this STP is to describe the test conditions and procedures
necessary to test and certify civilian manufacturer submitted CBRN Full
Facepiece Respiratory Protective Device (RPD) certification applications
for NIOSH approval. A CBRN Full Facepiece Respiratory Protective Device
being a complete tight fitting or loose fitting, full facepiece respirator,
properly outfitted with NIOSH recognized manufacturer unique components
and a compatible negative pressure air-filtering device or supplied air
cylinder that is installed per the manufacturer's current user instructions.
The STP is used to test candidate CBRN RPD against corn oil aerosol while
worn by a human test subject breathing in a dynamic eleven exercise specific
sequence. Aerosol quantified instrumentation is remotely sensing internal
and external corn oil concentrations via the attachment of tubing to a
specific oral/nasal probe mounted in the tested RPD. The requirements
for this STP are to ensure that all CBRN RPD, granted NIOSH CBRN approval,
have:
Approvals: |
1st Level |
2nd Level |
3rd Level |
1.2.1. Self-donning full facepiece characteristics that can accommodate
a variety of facial sizes and shapes per the Los Alamos Anthropometric
study or equivalent.
1.2.2. User instructions for facepiece size selection and donning that
are easily understood, applicable to all components and represent the
current version.
1.2.3. A pass or fail result based on completing 11 LRPL and/or 11
MLRPL exercises/ two trials as determined by appropriate pass/fail criteria
for each class of RPD.
1.2.4 Been evaluated in negative pressure or a positive pressure mode
on a panel of 25 to 38 test subjects having facial sizes and shapes
that approximate the distribution of sizes and shapes of the applicable
statement of standard.
2. GENERAL:
2.1 This document describes the Determination of Laboratory Respirator
Protection Level (LRPL) Quantitative (Medium-Flow, Deep Probe, Corn Oil
Human Performance Test) Fit Factor test for the CBRN Full Facepiece RPD
in sufficient detail that a team of persons knowledgeable in the appropriate
technical field can select equipment with the necessary resolution, conduct
the test, and determine whether or not the RPD passes the specified test.
The procedure is a separate test under the NIOSH/NPPTL Respirator Branch
heading of RB-CET-STP-CBRN-0352 for challenge of Corn Oil Aerosol. The
procedure is designed to rigorously test the evaluated RPD on a human
test subject as a dynamic respiratory protective system and generate repeatable
and independent pass or fail results under defined laboratory conditions.
2.2 Any laboratory using this procedure to supply certification test
data to NIOSH will be subject to the provisions of the NIOSH Supplier
Qualification Program (SQP). This program is based on the tenets of ISO/IEC
17025, the NIOSH Manual of Analytical Methods and other NIOSH guidelines.
An initial complete quality system audit and follow on audits are requirements
of the program. Additional details of the program and its requirements
can be obtained directly from NIOSH/NPPTL Respirator Branch, QA Section.
2.3 This test is considered a human factors test that requires participation
of a minimum of 25 to a maximum of 38 human subjects to quantify the LRPL
performance level required of the CBRN RPD. The successful completion
of NIOSH/NPPPTL designated Live Agent Test (LAT) performance requirements,
specific for the type of RPD being considered for LRPL testing, must be
shown before LRPL testing commences on the submitted RPD. Upon completion
of the LRPL test, a Modified LRPL test is required to be performed on
those applications seeking CBRN APR approval.
2.4 This STP shall be used to test several different types of CBRN full
facepiece RPD for satisfactory Laboratory Respirator Protection Level
performance. The full facepeice CBRN RPD include but are not limited to:
Self-Contained Breathing Apparatus (SCBA, Open Circuit and Closed Circuit),
Supplied Air Respirators (SAR), Air-Purifying Respirators (APR), Air-Purifying
Escape Respirators (APER), Self-Contained Escape Respirators (SCER), SCBA/APR
Combination Respirator (SCBA/APR Combo), Powered Air-Purifying Respirators
(PAPR) and follow on CBRN Respirator designs as identified by NIOSH.
3. TEST EQUIPMENT / TEST ITEMS/ HUMAN SUBJECTS
3.1. The list of necessary test equipment and materials follows:
3.1.1. Corn oil - 99%, no equivalent. Commercial Product
Name; Maise Oil, Maydol, Mazola Oil, Maize Oil. Corn oil utilized must
comply with Chemical Abstract No. 8001-30-7 prior to test commencing.
Material Safety Data Sheets (MSDS) for the type of corn oil used must
be posted for review by all test subject and laboratory personnel in
accordance with EPA Right to Know regulations, applicable OSHA HAZCOM
requirements and this STP.
3.1.2. Environmental test chamber and plenum system or equivalent. The chamber shall be designed so that the individual(s) performing
LRPL testing are visible at all times while in the chamber. The chamber
design must meet local fire codes for enclosed spaces including an entry
vestibule designed to allow safe entry and exit from the chamber with
minimal disturbance to both aerosol concentration and uniformity. The
vestibule shall be large enough to accommodate entry vestibule door
swing and eight test subjects while the main entry chamber door is closed.
The test chamber shall be capable of maintaining spatial uniformity
within ±10 percent in the vicinity of the respirator being tested.
The challenge aerosol concentration shall not vary as a function of
time more than ±10 percent over the duration of a single test
(approximately 15 minutes). The aerosol challenge shall be characterized
continually by a known quantitative system, permanently available in
the test laboratory, to verify that the aerosol challenge is within
specified parameters as detailed in section 6. An example of an instrument
to verify spatial uniformity and chamber concentrations is the TSI DustTrak
photometers. See Figure 1.
Figure 1. Environmental Test Chamber
3.1.3 Environmental Control System or equivalent. The
Environmental Control System shall be capable of maintaining (20-80%
RH + 5%, 65-95 +5oF) a range of normal operating conditions with an
ambient target condition of70 oF, 50 % RH for all LRPL/MLRPL tests.
An example of an Environmental Control System, the DataAire Model DAP-2
Environmental Control System, is shown in Figure 2.
Figure 2
Environmental Control System
3.1.4 Aerosol Measurement System or equivalent: The
Aerosol Measurement System is used to measure the aerosol challenge
and leak concentration for accurately measured fit factors of at least
100,000. It will have a minimum limit of detection no < 0.01mg/m3,
or 0.01 percent. Examples of aerosol measurement systems are the TSI
Laser Photometer Model 8520 and 8587 rear light scattering laser photometers.
See figure 3.
Figure 3, Aerosol Measurement
Systems
3.1.5 Aerosol Generator or equivalent. The aerosol
generator shall be capable of maintaining 20 to 26 mg/m3 of corn oil
challenge aerosol concentration with a Mass Median Aerodynamic Diameter
(MMAD) of 0.4 to 0.7 µm in the test chamber. The geometric standard
deviation shall be less than 2.0. The equipment shall be capable of
operation with out using recycled air. An example of an aerosol generator
system, the MSP Model 2045 High Output Aerosol Generator, is shown in
Figure 4.
Figure 4
Aerosol Generator
3.1.6. Communications System. A means of providing
minimum one-way and maximum two-way communication between the test subject(s)
and the test conductor(s) shall be provided. Non-verbal communication
between test subjects inside test chamber and attending laboratory technicians
is acceptable provided all personnel are adequately trained and supervised.
3.1.7. Facial Size Measurement, Calipers or equivalent. Calipers
shall be used to measure test participants for placement in panels identified
in Appendix A. Examples of calipers are sliding measurement calipers,
Seritex model GPM 104, 0-200 mm length, spreading measurement calipers,
Seritex model GPM 106, 0 - 300 mm width or electronic data generating
caliper. Calipers can be manual or electronic with the manual calipers
being the default. All calipers require strict calibration and adherence
to a verifiable calibration program during all phases of LRPL/MLRPL
testing. See figure 5, Facial Size Measurement Calipers. Figure 6 is
an example of software available to manage the panel test measurements
and placement of subjects.
Figure 5, Facial Size Measurement
Calipers
Figure 6, Sample LANL Panel Calibration
Software
3.1.9. Tubing or equivalent. Tygon tubing (1/4-inch
i.d.) and connectors to mate the facepiece probes to photometers are
required. Tubing distances and maintenance must be verifiable during
all phases of testing.
3.1.10. Facepiece Probes or equivalent. The probes
shall be of the shape defined by Liu [AIHAJ (45); 278-283, 1984] and
shall not interfere with the fit or function of the respirator. Figure
6, below is an interior view of a sample RPD probed in the oral nasal
region of the nose cup. Figure 7, is an exterior view of a probed RPD
showing the metal interface for tubing and penetration through the lens
and nose cup.
Figure 7, Sample Interior RPD Probe
Figure 8, Exterior View of
sample LRPL Probed RPD
3.2. Required CBRN APR Test Items:
3.2.1. Test RPD Facepieces. Each applicant shall provide
25 to 38 full facepiece RPD of production quality, in the NIOSH agreed
configuration, in each size according to the testing requirements set
forth in Appendix B of this STP. Figure 9, is a representative sample
photograph of ongoing probing of RPD covering specific determined sizes.
User instructions for self-donning and system attachments or other hardware
are required for each RPD submitted for test. Test factors such as weight
of accessories, weight of critical components, type of head harness
used and identical LAT configuration tested must be considered and factored
into the testable configuration. Twenty-five (25) RPD are required if
one universal size is tested. Twenty-nine (29) RPD if two sizes (14
Small/Medium and 15 Medium/Large) are tested. And thirty-eight (38)
RPD if three sizes (10 Small, 17 Medium and 11 Large) are submitted.
RPDs are configured by manufacturers during the pre-test phase and issued
to test subjects based on test laboratory interpretation of clear manufacturer
sizing instructions specified in applicable RPD user instructions provided
by the manufacturer.
Figure 9, Probed and Un-probed
Sample RPD
3.3. Human Factors:
3.3.1 Test Subjects. Twenty-five to thirty-eight human
test subjects are required for this test. All procedures and requirements
specified in the NIOSH Human Subject Review Board (HSRB) Protocol HSRB-03-NPPTL-06XP
entitled, "Determination of Laboratory Respirator Protection Level
(LRPL) Testing (Quantitative) for Respiratory Protective Devices"
dated March xx, 2003, shall be followed and met. Informed consent will
be obtained from each volunteer upon completion of the Volunteer Agreement
Affidavit and Volunteer Agreement Affidavit Explanation contained in
Protocol No, HSRB-02-NPPTL-06XP. The test subjects shall be subjected
to medical examinations as defined in HSRB-02-NPPTL-06XP and supplemental
facial measurements. The electronic and manual caliper facial measurements
shall be used to determine facial size and panel placement prior to
each test subject donning a new type of RPD or new manufacturer application.
3.3.2 Test Administrator(s). Administrators shall
have successfully completed the CDC/ATSDR Scientific Ethics Training,
the DHHS/NIH Human Participant Protections Education for Research Teams
or an equivalent NIOSH sanctioned course prior to being assigned as
the NIOSH LRPL HSRB contact. Note: The NIOSH Human Subject Review Board
will determine if specific courses as stated above are equivalent.
4. TESTING REQUIREMENTS AND CONDITIONS:
4.1. Calibration. Prior to beginning any testing, all
measuring equipment utilized for final measurements as part of this testing
must have been calibrated within the preceding 12 months, or as specified
by the equipment manufacturer, using a method traceable to the National
Institute of Standards and Technology (NIST). Equipment calibration records
shall be available for examination at each testing facility. Laboratory
technicians will check calibration prior to the conduct of the testing.
A statement that all test equipment is within calibration shall be attested
by the lab technician on each NIOSH test report.
4.2. Safety. Normal laboratory safety practices must
be observed. This includes safety precautions described in the current
NIOSH Bruceton Research Center Laboratory Safety Manual or site-specific
procedures that are applicable to health and safety requirements.
4.3. Certification Inventory. Test facility personnel
will confirm that the model of RPD facepiece submitted for LRPL testing
is the same model and configuration as submitted under the NIOSH application
for certification with the required accessories as defined by the manufacturer
and successfully live agent tested. Part number inspection, location and
referencing must be accurate and complete before test begins. Any accessories
that effect form, fit, function, or provide a protective quality shall
be installed on the RPD facepiece and subject to LRPL testing. NIOSH/NPPTL
Guidelines for Identification of Test Configurations for Exposure to GB/HD,
dated March 7, 2003, establishes the RPD current testable configuration
for LAT and ultimately that configuration should match the configuration
tested for LRPL and Modified LRPL fit factors. Facility personnel are
required to keep a certification inventory, when complete, prior to LRPL
commencing. Individual manufacturer RPD equipment stocks are required
to be separated & covered between manufacturers.
4.4. Probing. Each RPD facepiece shall be probed and
verified functional prior to issue to test subjects by lab personnel for
purposes of measuring concentrations of corn oil inside the facepiece
nosecup or requested configuration in accordance with paragraph 3 of this
STP. For those RPD without nose cups defining the oral nasal region, sampling
probe must still extend into the breathing zone per Para 3 of this STP.
The test facility administrator or his staff probes the RPD. The RPD sampling
location shall be in the oral/nasal region only. The optimum sampling
probe position is approximately 1/4 inch from the skin at the point of
quadrilateral symmetry of the mouth and nose, i.e. midway between the
nose and upper lip. The exact final position of the sample probe will
depend upon the design of the RPD being evaluated.
4.5. User Instructions. Prior to conducting the test,
the Users Instructions provided with the test equipment shall be reviewed
by the test facility personnel and the test subjects. Test subjects will
be taught by the principal investigator or a facility representative on
the areas of manufacturer's size selection, donning, fit check, doffing,
and other fitting procedures for the RPD facepiece. Any clarifications
or supplemental instructions provided by manufacturer representatives
at the time of certification inventory, during the test or after the test
must be NIOSH reviewed prior to incorporation into revised User Instructions
before final NIOSH approval is granted.
4.6. Self Donning. Each test subject shall perform an
unassisted donning of the RPD facepiece in accordance with the manufacturer's
instructions prior to entering the corn oil LRPL chamber. Each test subject
conducting self -donning under supervision of test facility personnel
is permitted time to make the appropriate adjustments to the facepiece
until they are satisfied that they are wearing the full facepiece in compliance
with the manufacturer's Users Instructions prior to entering the chamber.
Self-Donning relies on the clarity of the user instructions addressing
head harness pull-tab sequence, faceblank orientation and other RPD component
orientations.
4.7. Air Flow Sampling. Air shall be sampled out of
the respirator oral nasal region at a range of 2.2 +/-0.2 Lpm. The method
in which the sampling probe is installed shall not interfere with RPD
performance and shall minimize sampling biases.
4.8. RPD Protection Level Adaptation Measures. All RPD
that require adaptation to support LRPL testing must have accurate user
instructions that address conversion of that RPD to a manufacturer sanctioned
negative pressure testable configuration in accordance with the applicable
NIOSH/NPPTL RPD STP in effect. LRPL protection level testing of full facepieces
used on Open Circuit CBRN SCBAs and SARs under this procedure will be
accomplished by following the manufacturer's instructions for temporarily
converting the facepiece into an Air-Purifying Respirator with appropriate
P100 filter(s). The manufacturer must furnish the adapter and like user
instructions for this conversion. Facepiece modifications made to accommodate
this testing shall not significantly alter the fit of the respirator.
The weight and other characteristics of the facepiece assembly used during
this protection level testing should be representative of the facepiece
used on the SCBA or SAR. Accessories must be provided on CBRN SCBA and
SAR facepieces submitted for testing when the operation of the accessory
could affect form, fit or function.
4.9. LRPL Exposure Chamber Conditions:
4.9.1. Temperature Range = 68-80 °F
4.9.2. Relative Humidity Range = 50 + 10 %
4.9.3 Corn Oil Challenge Concentration = 22 + 2.0 mg/m3
4.9.4 The oxygen level shall be at least 20% for the duration of each
test.
5. PROCEDURE:
Note: Paragraph 3 of this STP contains examples of LRPL equipment and
select manufacturer's RPD. Review the manufacturer's operation and maintenance
manuals for calibration instructions, operational use, and maintenance
procedures prior to commencing this STP.
5.1. General. This procedure describes the Laboratory
Respirator Protection Level (LRPL) performance test for ensuring that
the level of respiratory protection provided by the CBRN Full Facepiece
Respiratory Protective Devices (RPD) meets or exceeds the requirements
defined in the Statement of Standard for that particular CBRN RPD being
tested. Refer to the current Statement of Standard for the CBRN RPD being
tested for specific data. This procedure describes the required sample
size, test equipment, data collection methods, human use protocol requirements,
and the specific performance requirement for RPD being tested.
SCBA, open circuit, is LRPL tested in a negative pressure configuration
using the identical LAT configuration with the deletion of the regulator
and cylinder hardware but with the addition of a negative pressure adapter
using P100 filters.
5.2. Number of Test Samples.
5.2.1. See paragraph 3 and Appendix B of this STP for quantities per
size.
5.2.2. All CBRN RPD shall be individually numbered with an indelible
pen or tagged in a sequence that the number can be correlated to the
NIOSH application number (TN), manufacturer, and administrative sequence
number so it can be tracked throughout the LRPL.
5.2.3. The administrative sequence numbers are replicated in the test
summary data sheets and indicate product performance per the stated
requirement.
5.3. Test Equipment and Chamber Set-Up:
5.3.1. Test facility staff will install the sampling probe in each
facepiece submitted under the applicable NIOSH TN and verify the integrity
of probes before physical testing is began. A short length of tubing
will then connect the sample probes in the masks to the aerosol detector
unit.
5.3.2. In accordance with local operational standard procedures, add
corn oil to the aerosol generators and allow 15 minutes for the chamber
concentration to stabilize.
5.3.3. Electronic and manual caliper facial measurements shall be used
to determine facial size and panel placement prior to each test subject
donning a new type of RPD or starting a new manufacturer RPD application.
5.3.4. Probes that do not clearly enter the oral nasal region, penetrate
just the eye lens without penetrating the oral nasal nose cup, penetrate
through a faceblank molded seam creating a possible seal leak or enter
the nose cup but are blocked by internal respirator parts are considered
inadequate test probes.
5.4. Conducting the LRPL Test:
5.4.1. Panels: Test subjects shall be selected to
cover all the cells within the panels referenced in Appendix A. Each
LRPL test shall consist of 2 trials. A minimum of 50 data points and
a maximum of 76 data points shall be collected from two self-donnings
by test subjects of each facepiece size of each RPD submitted to NIOSH,
as prescribed in Appendix B. At a minimum, anthropometrical measurements
face length (Menton-Nasal Root Depression or Menton-Sellion) and face
width (Bizygomatic diameter) shall be taken for facepiece size determination
per LRPL. In addition, neck circumference shall be recorded for respirator
systems that use a neck dam or second skirt. The test subject anthropometrical
panel results must fall out into the panel box requirements outlined
in Appendix B. These results determine what size RPD is issued to the
test subject. Those test subjects that are determined to be on the border
line between various indicated panel cells must be re-measured prior
to LRPL testing starting and confirmed what panel box they fall into.
For those cases, were a test subject is rated in a dual size category
panel box (M/L or S/M), the use of expert sizing by test facility personnel
is required to determine what size is initially tested twice. If test
subjects fail one dual size category twice, test facility personnel
are authorized to resize the individual if panel test subject availability
is in demand.
5.4.2. Training. The RPD facepieces shall be properly
sized and assigned to clean-shaven test subjects by trained test facility
personnel. Prior to LRPL testing, test subject training will be conducted
by test facility personnel based on the manufacturer's NIOSH recognized
Users Instructions. After initial instruction and eleven exercise hands
on demonstration, each test subject shall practice donning (15 minutes)
and wearing the RPD continuously for 15 minutes before entering the test
chamber. Test subjects do not attach critical components to the RPD. Test
facility personnel attach all critical components, per the manufacturer's
user instructions. The instruction period will be a minimum of 10 minutes
and a maximum of 30 minutes. All test subjects shall be trained. Mentoring
of training time and training subjects is required to ensure effective
instruction and follow on actions are performed correctly. Procedures
for doffing, trouble shooting, negative seal checks, head harness tightening,
and accessory interfacing with required power/air cylinder sources must
be taught to test subjects by test facility personnel. Manufacturers may
request the opportunity to observe LRPL testing of their equipment, with
prior notification to NIOSH/NPPTL.
5.4.3. Ready Line. After the test subjects are trained
in donning and doffing the RPD, issued administrative numbers, complete
applicable administrative paperwork, the subjects are moved to the ready
line in groups of eight or an equivalent number based on the number of
operational photometer test input lines.
5.4.4. Entry and Exit. Test subjects entering and leaving
the corn oil-charged chamber must be processed in accordance with paragraph
3 of this STP and not adversely affect chamber test conditions in between
trials. Chamber concentration is required to be monitored continuously
and compliant during the entire conduct of each individual LRPL test.
5.4.5. LRPL Exercises. The LRPL test consists of a set
of eleven standard exercises that use eight (8) basic US Department of
Labor, Occupational Safety and Health Administration (OSHA) Quantitative
Fit Test (QNFT) exercises plus three (3)* additional QNFT exercises generated
from emergency response forums. They are one-minute routines devised to
stress the face seal and material integrity of the respirator facepiece
while it is worn by a human test subject. The appropriate number of test
subjects (based on Appendix B) will successively don and wear the CBRN
RPD into the chamber. The exercise routine listed below shall be used
to stress the face seal and approximate field use conditions under controlled
laboratory settings. During each trial of a LRPL test, each human subject
will perform the following eleven exercises for one-minute each **:
5.4.5.1 Normal Breathing: In a normal standing position
with hands to the sides or rear, without talking, the subject shall
breathe normally for one minute. A recommended procedure is to inhale
through the nose and exhale through the nose at a normal pace. Do not
touch any portion of the RPD during any part of the LRPL active test,
to include the RPD's sample line.
5.4.5.2 Deep Breathing: In a normal standing position
as above, the subject shall breathe slowly and deeply for one minute,
being careful not to hyperventilate. A recommended procedure is to inhale
deeply through the nose and exhale through the mouth.
5.4.5.3 Turn Head Side to Side: Standing in place,
with arms to side, the subject shall slowly turn head from side to side
for one minute between the extreme positions on each side. The head
shall be held at each extreme momentarily so the subject can inhale
at each side. Do not deliberately hit the shoulder with any part of
the RPD during the conduct of the exercise.
5.4.5.4 Move Head Up and Down: Standing in place,
the subject shall slowly move head up and down, starting at level plane,
move the head up slowly so the eyes are looking straight up at the ceiling,
inhale and hold for one second. Slowly move down past the horizontal
level start point to the end point where the chin just touches the chest.
Continue the process until told to stop at the level position.
5.4.5.5 Recite the Rainbow Reading Passage or equivalent: The subject shall talk out loud while reading a copy of the passage
entitled Rainbow Passage. Normal breathing is required. Volume of speaking
should be loud enough so as to be understandable by the test facility
personnel in the control office. Subject will keep reading the passage
until told to stop.
5.4.5.6 Sight a Mock Rifle*. While in normal breathing,
pick up the mock half-length rifle sample. Test subjects shoulder the
mock rifle in the favored shooting posture shoulder position. Bend the
head while keeping the RPD fitted so as to allow a realistic sight picture
to be attained by placing the cheek unhindered by RPD components (such
as a canister) as close as possible to the rifle stock and rear sight
aperture. Hold the cheek to stock position for one second. While bending
the head to attain a modified sight picture, extend the non-shooting
arm and hand to simulate holding the remaining stock of a standard rifle.
After attaining this posture, drop the arms, while still holding on
to the mock rifle, to the side. Continue taking up realistic sight pictures
with the mock rifle as described until told to stop or one minute. Place
the mock rifle down.
5.4.5.7 Reach for Floor and Ceiling (Modified Bending Over
exercise 29CFR1910): While in normal breathing, standing, feet
shoulder width apart and at arms length from each test subject, subject
bends at the waist as if to touch toes/floor. After touching/reaching
fully for the toes/floor, subject comes back up at a normal pace, extending
arms fully and reaching for the maximum length of arms to the ceiling
direction. Keeping the arms locked, continue the procedure until told
to stop or for one minute.
5.4.5.8 On Hands and Knees, Look Side to Side *: Before
starting, test subject ensures enough room is available between equipment,
sample line and other test subjects. In normal breathing, at a normal
pace, drop to all fours and extend the head looking straight out. Starting
at the center, move the head to the right or left full extreme and hold
for one second. Inhale after that one second while holding the head
at the extreme extension. Continue doing this exercise, not hitting
the RPD aggressively, for one minute or told to stop. At a normal pace,
return to the standing position.
5.4.5.9 Facial Grimace: While in normal breathing
and standing, the test subject will grimace the face by smiling or frowning.
Starting with the mouth closed, create a smile or frown that is physically
felt by the test subject while wearing the tested RPD. It is recommended
that smiling and frowning be alternated during the one-minute exercise.
5.4.5.10 Climb the Stairs At Regular Pace*: Test subjects
pair off in twos, while in normal breathing, one test subject of the
a pair holds the appropriate stair case or ladder while the other test
subject climbs up at a normal pace and back down at a normal pace. Upon
the first subject completing one repetition of up and down, the second
subject climbs while the first subject holds the ladder, if necessary.
Continue the cycle until one minuet expires or told to stop. Return
to the floor standing position. Ensure sample lines are not restricting
movement during the climb.
5.4.5.11 Normal Breathing: In a normal standing position
with hands to the sides or rear, without talking, the subject shall
breathe normally for one minute. A recommended procedure is to inhale
through the nose and exhale through the nose at a normal pace. Do not
touch any portion of the RPD during any part of the LRPL active test.
Disconnect the sample line as instructed.
* One of three additional emergency response exercises added for CBRN
tests.
** Exercises must be done in this sequence, starting with number one
(1) normal breathing and ending with number eleven (11), normal breathing.
5.5. At the conclusion of each trial, test subjects shall exit from the
test chamber, return to the ready line and await further instructions.
All those subjects identified to doff will commence doffing and those
subjects that are being reviewed for test failure protocol will remain
with RPD donned until told to doff.
5.6. All comments and observations by test subjects, which are voluntary,
will be written on the test data sheet.
5.7. After a brief intermission (1-10 minutes), each test subject will
re-don the same respirator facepiece and repeat Steps 5.4.3 through 5.5
to complete the 2nd trial for the test. Each test consists of two trails
using the same RPD for each trial with the same test subject for each
trial.
5.8. If a RPD is identified as a failure upon trial termination, test
facility personnel will conduct failure assessment protocol of the RPD
in two phases. First phase is to inspect the RPD while it is still donned
on the test subject. Second phase is to inspect the RPD when it is doffed.
Post test failure analysis should consist of inspection of the test subjects
eye to eye lens positioning, head harness positioning, head harness strap
twists, nose cup scrunched up on face, hair in the faceblank seal area,
canister not on securely, probe lose, missing or on a molded seal or surface
causing seal gap or any other case dependent situations. If noted deficiencies
are confirmed with the RPD being improperly probed, reassign another like,
but serviceable RPD to the test subject and retest for two complete trials.
If the RPD has a serviceable probe but continues to fail, log it as a
LRPL failure. Only inspect the probe assembly if test results are flat
lined or suddenly go flat lined after successful exercise results are
indicated. Probe failures such as ripped faceblank material or inadequate
probe sealing areas are cause for reanalysis of the determined probe entry
point. In cases, where the RPD cannot be probed successfully by the test
facility, manufacturer Quantitative Fit Test (QNFT) kits can be reviewed
and considered for use, but only as a last resort. If manufacturer instructions
specify use of pre-test Port-a-Count Fit Tester during test subject respirator
selection process, ensure serviceable and calibrated Port-A-Count Fit
Tester is available, conduct test and determine suitability of test subject
before starting LRPL or MLRPL testing.
5.9. MLRPL for Negative Pressure Fullface Respirators (CBRN APR)
Test Sequence: Modified LRPL (MLRPL) Canister (Weight Enhanced
Canister) must weigh 500 grams as weighed in by test agency. Canister
must measure 5 inches. In order to do this task, the testing laboratory
will accept the canisters submitted with the application. Select 8 canisters
at random to be modified to meet the statement of standard requirements.
No surrogate canisters are authorized. Testing laboratory will apply required
measures to make the submitted canister weigh 500 grams and measure 5
inches in width. Required measures for enhancing each canister must be
of sound engineering design, maintain enhanced design through out the
entire test and have minimal impact on field of view. Examples consist
of dye cut Styrofoam outserts with known value metal weights secured inside,
weighted metal tape of known weight or other recognized weight enhancement
systems. It is critical that the weight be uniformly distributed over
the entire outside dimension of the canister, whether it is on the circular
surface or the flat inlet/outlet surfaces. The final design enhancement
technique must be submitted and demonstrated through Verification Testing
(V-Test) to NIOSH for final approval prior to actual testing commencing.
Deviations from this final approved design concept are not authorized
unless requested in advance to NIOSH and changes demonstrate increased
test proficiency. At random, 8 subjects are chosen out of the original
LRPL test panel. The respirators assigned to those 8 subjects will have
the CBRN canister for normal LRPL replaced with the Modified LRPL (MLRPL)
canister as directed by the testing laboratory and NIOSH. Two trials of
the MLRPL are required and a passing LRPL of 2000 per trial must be met.
The MLRPL overall pass value is 94%. MLRPL can have one test failure out
of 16 trials using the same 8 test subjects with properly configured MLRPL
canisters. If two test different of identical test subjects out of 16
trials fail the MLRPL, the application is a failure and will be denied.
MLRPL test results will be included in final CBRN APR LRPL test data sheets
and designated as Modified LRPL Test Subject -01-16 with corresponding
size and TN as required. The same test procedure for traditional LRPL
for CBRN APR applies to the conduct of the MLRPL with 2000 being the passing
LRPL value per test subject.
6. PASS/FAIL CRITERIA
6.1.1 The criterion for conduct of this test is set forth in 42 CFR,
Part 84, Subpart G, Section 84.63 (a, c, and d) Volume 60, Number 110,
June 8, 1995 and applicable RPD current statement of standards in final
approved form. Each respirator and respirator component shall when tested
by the applicant and by the Institute, meet the applicable requirements
set forth in 42 CFR Part 84, subparts G, H, I J, K, and applicable portions
of L, N and KK. All applicable manufacturer user instructions that address
seal enhancement kits and other critical seal components/tasks must
be clearly depicted in final NIOSH approved documents and present during
testing.
6.1.2 CBRN SCBA (Open Circuit): Each CBRN Open-Circuit,
Pressure Demand, Self Contained Breathing Apparatus respirator facepiece
minus air pressure hardware and cylinder is adapted to negative pressure
configuration, probed by test lab and configured with all identical
LAT accessories and components prior to testing. This configuration
is worn by a human test subject in an atmosphere containing 20 to 26
mg/m3 of corn oil aerosol with a Mass Median Aerodynamic Diameter (MMAD)
of 0.4 to 0.7 um and the minimum LRPL shall be equal to or greater than
500 (minimum) Fit Factor for 95 +/- 0.26 % of the test subjects evaluated
in accordance with NIOSH Procedure No. RCT-CBRN-STP-0202, Appendix B
or the current RPD LRPL STP in effect. Each wearer shall not be subjected
to any undue discomfort or encumbrance because of the fit, air delivery
or other features of the respirator during the test period.
6.1.3 CBRN APR:
6.1.3.1 Traditional LRPL for CBRN APR: The measured
LRPL for each full facepiece, air purifying respirator shall be 2000,
when the APR facepiece is worn by a human test subject and tested
in an atmosphere containing 20-40 mg/m3 of corn oil aerosol of a MMAD
of 0.4 to 0.6um. NIOSH procedure No. RB-CET-STP-CBRN-0352 specifies
the procedure. All submitted accessories effecting weight, form, fit
or function are required to be on the APR prior, during and in post
testing phases.
6.1.3.2 Modified LRPL (Practical Performance) for CBRN APR: A modified LRPL (MLRPL) shall be performed using respirators, provided
in the original CBRN APR certification application, fitted with the
submitted canister adapted to become a NIOSH weight enhanced canister
weighing a maximum of 500 grams and sized to the maximum permissible
dimensions specified in CBRN APR Statement of Standard, Para 3.4 and
3.11. Such dimensions should exist that the canister shall pass through
a five (5) inch diameter opening with the threaded connector perpendicular
to the five (5) inch diameter opening while weighing maximum of 500
grams in a as is/ready to use canister configuration modified to be
a weight enhanced canister. A minimum/maximum of eight (8) CBRN APR
shall be tested under traditional LRPL protocol using modified canister
enhancements to fulfill passing fit factors of 2000 for all eight
(8) respirators, separate from the completion of traditional CBRN
APR LRPL requirements. If three sizes are submitted the test tariff
is 2 SM, 4 MED and 2 LRG. If two sizes are submitted the test tariff
is 4 SM/MED and 4 MED/LRG. If one size, universal, is submitted all
eight (8) are "one size fits all/universal". NIOSH Procedure
NO. RB-CET-STP-CBRN-0352 specifies the procedure. One failure is authorized
out of 16 test trials at 8 test subjects per trial (a 93.75% Passage
Rate rounded up to 94%).
6.1.4 CBRN ESCAPE APR: To be published.
6.1.5 CBRN Self - Contained ESCAPE Respirator: To
be published
6.1.6 CBRN SCBA/APR Combination: To be determined.
6.1.7 CBRN PAPR: To be determined.
6.1.8 CBRN SCBA (Closed Circuit): To be published.
6.1.9 CBRN Follow On Concept Respirators: To be determined
6.1.10 In addition to the stated requirements NIOSH/NPPTL reserves
the right to require, as a further condition of approval, any additional
requirements deemed necessary to establish the quality, effectiveness,
and safety of any respirator used as protection against hazardous CBRN
atmospheres.
6.1.11 Where it is determined after receipt of an application that
additional requirements will be required for approval, the Institute
will notify the applicant in writing of these additional requirements,
and necessary examinations, inspections, or tests, stating generally
the reasons for such requirements, examinations, inspections, or tests.
6.1.12 RPD facepieces shall provide for the optional use of corrective
spectacles or lenses, which shall not reduce the respiratory protective
qualities of the apparatus.
6.1.13 RPD facepiece shall be designed to prevent eyepiece, spectacle
and lens fogging.
7. RECORDS\TEST SHEETS
7.1 All test data will be recorded on the LABORATORY RESPIRATOR PROTECTION
LEVEL TEST QUANTITATIVE ,MEDIUM-FLOW, DEEP PROBE, CORN OIL FIT FACTOR
PERFORMANCE TEST FOR CBRN FULL FACEPIECE RESPIRATORY PROTECTIVE DEVICES
WITH FULL FACEPIECES test data sheets (See Appendix C.)
7.2 All videotapes and photographs of the actual test being performed
and of the tested equipment shall be maintained in the task file as part
of the permanent record.
7.3 All equipment failing any portion of this test will be handled as
follows;
7.3.1 If the failure occurs on a new certification application, or
extension of approval application, the Test Facility Manager (Principal
Investigator or designee) will send a test report to the NIOSH Certification
Evaluation and Testing (CET) Section Chief and prepare the hardware
for return to the manufacturer.
7.3.2 If the failure occurs on hardware examined under an Off-the-Shelf
Audit, the hardware will be examined by a laboratory technician and
the CET Section Chief for cause. All equipment failing any portion of
this test may be sent to the manufacturer for examination and then returned
to NIOSH. However, the hardware tested shall be held at the testing
laboratory until authorized for release by the CET Section Chief, or
his designee, following the standard operating procedures outlined in
Procedure for Scheduling, and Processing Post-Certification Product
Audits, RB-SOP-005-00.
7.3.3 If a RPD fails the criteria specified in Para 6.0 of this STP,
ensure all measures are taken to ascertain the reason/cause for failure,
conduct all post test inspections in accordance with Para 5.11 of this
STP that support the accuracy of the reported failure and provide NIOSH
with written Test Incident Reports (TIR), digital photos of assessment
and recommendations as required.
RECORD OF CHANGE:
Appendix A, One Size Fits All/Universal Panel, to CBRN RPD LRPL STP-0352
25 Test Subject, One Size/Universal, Member Panel for
Testing of NIOSH CBRN Full-Face RPD
Note: For the purpose of this testing, test subjects in each
box may be male or female.
Appendix B
Test Panels Used for the Laboratory Respirator Protection Level Tests
1. Manufacturers with 3 Facepiece Sizes: 38 test subjects, two
replicates, and total 76 data points. The maximum number of subjects equals
the maximum number of facepieces required in the following tariff:
Small size: 10 each
Panel face sizes -Boxes 1, 2, 3, 4; panel size 10 (2 or 3 each size, 10
subjects, 20 total samples)
Medium size: 17 each
Panel face sizes - Boxes 3, 4, 5, 6, 7, 8; panel size 17 (2 or 3 each
size, 17 subjects, 34 total samples)
Large size: 11 each
Panel face sizes - Boxes 7, 8, 9, 10; panel size 11 (2 or 3 each size,
11 subjects, 22 total samples)
2. Manufacturers with 2 Facepiece Sizes: 29 test subjects, two
replicates, and total 58 data points. The maximum number of subjects equals
the maximum number of facepieces required.
Small / Medium size: 14 each
Panel face sizes 1, 2, 3, 4, 5, 6; panel size 14 (2 or 3 each size, 14
subjects, 28 total samples)
Medium / Large size: 15 each
Panel face sizes 5, 6, 7, 8, 9, 10; panel size 15 (2 or 3 each size, 15
subjects, 30 total samples)
3. Manufacturers with a One-Size-Fits-All Facepiece: 25 test
subjects, two replicates, and total 50 data points. Panel size - Every
Box 1-10; panel size 25 (2 or 3 each size, 25 subjects, 50 total samples)
PASS/FAIL Criteria: Whenever a full panel of sizes 1
through 10 is used to evaluate a one-size-fits-all CBRN RPD facepiece,
2 failures, 96%, will be allowed. This is because, when a 25-person panel
size is used consisting of all 10 facial sizes, it is statistically unlikely
that any respirator design can be expected to fit all individuals due
to the human variability in facial structure. Only 3 failures, 94.83 %
(~ 95%), will be allowed for two facepiece sizes, and 4 failures, 94.74%
(~ 95%), will be allowed for 3 facepiece sizes. Multiple-sized RPD facepieces
are designed to fit specific facial size ranges (such as small) but are
not expected to fit all subjects of that size range. When a small sample
size is used (<25), statistical analysis is not practical. If more
than three sizes are submitted, NIOSH will determine which sizes to test
based on manufacturer recommendations. If sizing enhancement tools or
products are used to maintain user seal, these products must demonstrate
LAT passing criteria in accordance with applicable RPD LAT STP. Each test
subject will perform testing with 2 donnings of the same size respirator
facepiece per panel member. The second donning will be a redonning of
the same facepiece.
NOTES: Some panel members may be the same individuals in a dual role
filling the cell requirements of 2 panels for the facepiece sizes. The
data for each test subject donning (sample) are judged individually against
the pass/fail criteria. This information also supports MLRPL testing.
Appendix C
CBRN RPD LRPL Test Data Sheets
To Be Published (TBP)
To Be Determined (TBD)
C1. CBRN SCBA: Current DEIMS Format
C.2. CBRN APR: TBP
C.3. CBRN Air-Purifying Escape Respirator (APER): TBP
C.4. CBRN Self-Contained Escape Respirator (SCER): TBP
C.5. CBRN SCBA/PAPR/APR Combination Respirators: TBD
C.6. CBRN PAPR: TBD
C.7. CBRN SCBA, Closed Circuit: TBD
C.8 CBRN Follow On Concept Respirators: TBD
CBRN SCBA Data Sheet to Appendix C, CBRN RPD LRPL Test Data Sheets,
NIOSH Procedure Number: RB-CET-STP-CBRN - 0352 (Page 1)
CBRN SCBA Data Sheet to Appendix C, CBRN RPD LRPL Test Data Sheets,
NIOSH Procedure Number: RB-CET-STP-CBRN - 0352 (page 2)
CBRN SCBA Data Sheet to Appendix C, CBRN RPD LRPL Test Data Sheets,
NIOSH Procedure Number: RB-CET-STP-CBRN - 0352 (Page 3)
Appendix D
Laboratory Respirator Protection Level Test
Quantitative Corn Oil Fit Testing Procedure
For Chemical, Biological, Radiological and Nuclear RPD Evaluations
Medical Screening and Test Subject Consent Forms
TO BE UDPATED/APPROVED BASED ON FINAL SBCCOM HUC AND NIOSH HSRB INPUT
FOR FINAL STP. AS OF 5/30/2003, NIOSH DOCUMENT NOT OUT OF SBCCOM HUC SIGNATURE
REVIEW. AFTER SBCCOM REVIEW IT MUST GO TO NIOSH HSRB REVIEW PRIOR TO BEING
USED AS AN OFFICIAL NIOSH LRPL DOCUMENT FOR RPD CERTIFICATION. TKC, 5/30/2003,
PITTSBURGH, PA
NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH
(NIOSH)
CENTERS FOR DISEASE CONTROL AND PREVENTION
U.S. PUBLIC HEALTH SERVICE
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
AND
SOLDIERS AND BIOLOGICAL CHEMICAL COMMAND (SBCCOM)
U.S. ARMY
CONSENT TO PARTICIPATE IN A RESEARCH STUDY
----------------------------------------------------------------------
You have been asked to participate in a joint NIOSH
and SBCCOM research study. We explain here the
nature of your participation, describe your rights, and
specify how NIOSH and SBCCOM will treat your records.
----------------------------------------------------------------------
I. DESCRIPTION
1. Project Title: "LABORATORY RESPIRATOR PROTECTION LEVEL TEST QUANTITATIVE
(MEDIUM-FLOW DEEP PROBE CORN OIL) FOR RPD WITH FULL FACEPIECES STANDARD
TESTING PROCEDURE (STP)"
Document A: Medical Screening and Test Subject Consent
2. Sponsor and/or Project Officer: This project is a collaborative study
by NIOSH and SBCCOM with Co-Project Officers:
Alex G. Pappas, SBCCOM Mask Fit Test Facility Manager
3. Purpose and Benefits: The purpose of our overall study is to evaluate
and certify respirators to make sure they are safe and work properly.
The procedures for testing respirators have been developed jointly by
senior scientists and engineers from NIOSH and SBCCOM. Because of unique
test system requirements, the testing will be conducted at the SBCCOM
Fit Testing Facilities, Edgewood, Maryland under provisions of an Interagency
Agreement with the NIOSH Respirator Branch. Under the provisions of this
Interagency Agreement, SBCCOM will function as NIOSH's testing agent.
Information generated by this research project will benefit:
a. You, the participant, by providing a better understanding of respirators
and their performance. Also, you will receive a free limited annual
medical examination if you qualify to participate in the testing program.
However, annual medical physicals will be terminated at the end of the
program.
b. Workers who routinely use this same type of respirator, by ensuring
that respirators in the field perform as they were certified by NIOSH
to perform, and thus provide the expected level of respiratory protection.
c. Those involved in testing, certifying, and manufacturing respirators
by providing feedback on how respirators perform in the field.
d. Workers such as HazMat responders, firemen, police, and emergency
medical service personnel for protection against terrorism agents, toxic
compounds and oxygen deficiency.
II. CONDITIONS OF THE STUDY
1. Participation in this study consists of two parts. The first part is
a brief medical screening. If the results of your medical screening indicate
that you can participate in the testing of respirators, you will be invited
to enter a pool of subjects who will be called upon from time to time
to perform a series of simple tasks such as walking up stairs, turning
their head from side to side, or sighting a rifle while wearing a respirator.
At this time, we are only asking for your consent to perform the medical
screening. If you are eligible for the testing program, we will invite
you back and explain the respirator test program in greater detail.
The medical screening consists of:
a) a brief health questionnaire, asking general questions about current
physical condition, medical history, pulmonary illness or disease, and
experience with respirators and masks.
b) A resting EKG to test your heart. This involves attaching some electrodes
to the surface of the skin on your chest and legs and measuring your
heart beat. This is a painless procedure although some individuals may
develop a slight skin irritation or a mild rash from the electrode paste.
c) A breathing test (pulmonary function test) to measure your lung
capacity. This involves blowing as hard as you can into a tube. Some
individuals may become temporarily winded or lightheaded during the
breathing test. On rare occasions, an individual may faint.
d) A standard hearing test. The hearing test consists of a series of
sounds of different intensities and frequencies. All you need to do
is to signal every time you hear a noise through a set of earphones.
There are no apparent risks associated with the hearing test.
e) A measurement of your face to determine what size or model respirator
is most appropriate for you should you be called back for later testing.
The physical examination will be provided by a licensed physician at
no cost to you. . All hearing tests are given by qualified technicians.
The first portion of the test will take about 45 minutes.
You will be asked not to take part in uncomfortable or strenuous activity,
smoke, eat, or drink anything (other than plain water) for at least 2
hours before the physical examination.
2. Recruitment and Screening of Test Subjects: The U.S. Army Soldiers
and Biological Chemical Command will maintain a pool of perspective human
test subjects for use in the testing of respirators. All test subjects
will be healthy volunteers between the ages of 18 and 49 years. Compensation
will be given to non-Federal Government employees at the rate of $25.00
to $50.00 depending upon the test being conducted. Compensation will not
be given to Federal Government employees. No NIOSH employees will be included.
Prospective human test subjects are recruited by word-of-mouth.
Prospective test subjects will be screened for fitness to be added to
the NIOSH-SBCCOM LRPL human test subject pool.
Prior to testing all test subjects are given an annual physical examination
(which includes completing the OSHA Respirator Medical Evaluation Questionnaire
and Clinical History and Exam Form) by a qualified physician. Any new
test subjects (when required) will be given an interview and get their
faces measured (for size according to the Los Alamos schedule for face
sizes), have a physical, and be added to a pool of approximately 40-100
test subjects. Testing dates for respirator testing vary with respirator
manufacturer's request. On average for certification testing, 25 to 40
subjects will be selected from this pool (approximately 30 times per year)
to perform LRPL Quantitative Respirator Test. The frequency of certification
testing is dependent on the types of request from manufacturers but subjects
can expect to be called on approximately 10 times per year for testing.
If selected for testing in the NIOSH-SBCCOM research projects, there are
from 20 to 30 tests per project per year for one or two projects per year
for each test subject selected and tests are usually scheduled weekly.
Selection from the pool is determined by the availability of the test
subject. Prior to performing the LRPL Quantitative Test, test subjects
are administered the Screening Questionnaire for the LRPL Test. This is
to make certain the test subject does not have any problem completing
a moderate work test.
Criteria of the American College of Sports Medicine and the American
Heart Association will be used by a qualified physician to determine fitness
to do the LRPL tests. However, these criteria are meant to cover the testing
of all subjects, including many individuals who are tested for clinical
management purposes because they have various types of cardiac disease.
Since this project is interested in respirator performance and not an
individual's results, it will use essentially healthy test subjects. Therefore,
additional criteria are included to screen out certain subjects who may
have an increased risk during exercise.
SBCCOM contracts with a local health care provider to conduct the medical
examination and screening procedure. As part of this contract, the health
care provider provides a written summary of the examination and test results
to each prospective test subject. This written summary includes a statement
of the subject's suitability for participation in the testing at SBCCOM.
Each of the attached consent forms includes a draft of an example notification
letter. The actual letter is sent by the health care provider and is updated
from time to time.
The physician will evaluate all medical data and recommend those test
subjects suitable for addition to the NIOSH-SBCCOM test subject pool.
The physical examination will be repeated every year to determine a subject's
continued suitability of inclusion on the NIOSH-SBCCOM test subject pool.
If selected for the program, we will ask you back in about one month
to start the actual respirator testing. We will explain the procedures
in detail to you at that time and have you sign a separate consent form.
Once enrolled in the program you will be given this health evaluation
every 12 months for as long as you choose to continue in the testing program.
Inclusion Criteria: The majority of the test volunteers will be military
volunteers. As military personnel, they receive regular physical examinations
by a physician. Furthermore, they are required to be examined by a physician
if they should suffer any ailment or physical injury. The use of military
personnel will thus help to ensure that the volunteers will be in satisfactory
health prior to testing. Any individual who is in satisfactory health
and judged by the test director fit to wear a respirator and/or protective
clothing can participate as a test subject.
Exclusion Criteria: An inquiry of the health of the volunteers will be
made before they are allowed to be tested. Subjects will be excluded from
testing if there is any evidence of the following conditions: Heart or
circulatory dysfunctions, emphysema or other major respiratory dysfunctions,
claustrophobia, head injury, or any other bodily injury which would prohibit
the subject from wearing a mask and/or protective clothing and performing
the exercises. In addition, volunteers will not undergo testing if they
are currently for any reason deemed unfit such that the performance of
light to moderate exercise (under the test conditions specified) might
pose any significant health risk to the individual. The test director
will ensure that the individuals having the previously listed medical
conditions will be excluded from participating in the mask fit testing.
To certify that the subject has been questioned regarding the status of
his current health and relevant history of the medical criteria associated
with this type of test, the questionnaire will be provided for signature
as part of the Volunteer Agreement Explanation. Exclusion from the test
will be determined by the test director's review of the questionnaire.
Source of Subjects: The majority of the test volunteers will be military
volunteers. For most studies, U.S. Army military personnel will be recruited
as volunteers from troops stationed at Aberdeen Proving Ground, Maryland.
However, civilian test volunteers may also be used occasionally from Edgewood
Area, APG.
Subject Identification System: Prior to testing, each subject will be
assigned an identification number using a sequential numbering system.
All test data generated will be identified by subject number only to insure
confidentially of the subjects identity.
3. If you have any reaction to the medical screening procedures, you
should contact Mr. Alex G. Pappas, Mask Fit Test Facility Manager, SBCCOM
(410-436-3338), or a NIOSH representative to be appointed.
4. Injury from this project is unlikely. But if injury occurs, medical
care, other than emergency treatment, will not be provided. If you are
injured during testing through negligence of a SBCCOM or NIOSH employee,
you may be able to obtain compensation under Federal Law. If you want
to file a claim against the federal government your contact point is:
Public Health Service Claims Office (301) 443-1904. If you are injured
through the negligence of a NIOSH contractor, your claim would be against
the contractor, not the federal government.
Any serious incident of adverse reaction that should arise during the
conduct of this study at SBCCOM will be reported within one hour to Timothy
Williams, CIH, CSP, Master Industrial Hygienist and SBCCOM Human Use Chairman
at (410) 436-2302.
If you are injured during testing, you should also contact: Mr. Alex
G. Pappas, Mask Fit Test Facility Manager, SBCCOM (410-436-3338), or a
NIOSH representative to be appointed.
5. If you have questions about this research, contact: Mr. Alex G. Pappas,
Mask Fit Test Facility Manager, SBCCOM (410-436-3338), or a NIOSH representative
to be appointed. If you have questions about your treatment or rights
as a member of this study, contact: Michael J. Colligan, Ph.D., Chair,
NIOSH Human Subjects Review Board at (513) 533-8222; or Timothy Williams,
CIH, CSP, Master Industrial Hygienist and SBCCOM Human Use Chairman at
(410) 436-2302.
6. SBCCOM Mask Fit Test Facility staff will retain the results of each
military and civilian test subject's medical screening. SBCCOM, NIOSH,
the test subject and their authorized private physician will have access
to medical screening reports. The results of the medical examination will
be maintained in a locked file cabinet at the SBCCOM Mask Fit Test Facility
and will only be accessible to members of the research staff. NIOSH will
provide you and your doctor (if you wish) with all findings from your
medical tests and physical examination.
Your participation in the medical screening for this project is voluntary
and you may withdraw your consent and your participation in this study
at any time without penalty or loss of benefits to which you are otherwise
entitled. The frequency of respirator testing is dependent on the types
of request from manufacturers but subjects can expect to be called on
approximately 10 times per year for testing.
For the Medical Screening Test you will receive $50.00. If you are eligible
for the respirator testing program you will receive $25.00 per test depending
upon the length of the test for each visit or partial visit that you participate
in this study. Each visit may consist of multiple 45-minute tests over
a 1 to 4 hour testing period depending upon the respirator being tested.
7. Overall results of the testing of the respirators will not contain
information useful to you personally. In addition, the results contain
certain trade secrets and confidential design operation information that
NIOSH and SBCCOM will not release to the public. Because of this, we cannot
directly provide you with the overall study testing results. However,
the test report with all personal identifiers and trade secret information
removed would be available upon written request under the Freedom of Information
Act, 5 U.S.C. 552. Send your written request to:
Freedom of Information Act Officer
Centers for Disease Control and Prevention
1600 Clifton Road
Atlanta, Georgia 30337
NIOSH-SBCCOM SCREENING QUESTIONNAIRE FOR
Laboratory Respirator Protection Level Quantitative Fit Test.
1. Are you in good general health?
2. Do you have any pain when you:
|
Yes |
No |
a. Perform normal breathing
|
|
|
b. Perform deep breathing
|
|
|
c. Nod or turn your head from side to side
|
|
|
d. Move your head up and down
|
|
|
e. Recite the passages from literature
|
|
|
f. Reach for the floor and ceiling
|
|
|
g. Crawl on your hands and knees
|
|
|
h. Perform facial expressions like a grimace
|
|
|
i. Climb the stairs at regular pace
|
|
|
j. Sight a rifle ______ ______ |
|
|
3. Have you ever been treated by a physician for any of the following
ailments?
|
Yes |
No |
a. Collapsed lung
|
|
|
b. Dizziness or fainting spells
|
|
|
c. Chronic respiratory illness
|
|
|
d. Asthma
|
|
|
e. Claustrophobia or anxiety reaction
|
|
|
f. Shortness of breath or breathing problems
|
|
|
g. Heart problems
|
|
|
h. High blood pressure
|
|
|
4. Have you taken medication or seen a physician for any of the following
ailments within the last 15 days?
|
Yes |
No |
a. Dizziness or fainting spells
|
|
|
b. Chronic respiratory illness
|
|
|
c. Asthma
|
|
|
d. Shortness of breath
|
|
|
e. Heart trouble
|
|
|
f. High or low blood pressure
|
|
|
g. Ear, nose, or throat trouble
|
|
|
h. Sinusitis
|
|
|
i. Susceptibility to skin reactions
|
|
|
j. History of allergic diseases |
|
|
k. Upper respiratory tract infection |
|
|
5. Have you ever worn a NIOSH respirator or military respirator/mask before?
_____ _____
If so, did you have an adverse reaction before, during, or after wearing
the mask? _____ _____
TEST SUBJECT'S INITIALS _______________ DATE__________
III. USE OF INFORMATION
The National Institute for Occupational
Safety and Health (NIOSH) of the Centers for Disease Control and Prevention
(CDC), an agency of the Department of Health and Human Services, is authorized
to collect this information, including your social security number (if
applicable), under provisions of the Public Service Act, Section 301 (42
U.S.C. 241); Occupational Safety and Health Act, Section 20 (29 U.S.C.
669); and the Federal Mine Safety and Health Act of 1977, Section 501
(30 U.S.C. 95). The information you supply is voluntary and there is no
penalty for not providing it.
The data will be used to assess the performance of various respiratory
protective devices, to make sure they are safe and work properly. Data
will become part of CDC Privacy Act system 09-20-0159 "Records of
Subjects in Certification, Testing, Studies of Personal Protective Devices,
and Accident Investigations" and may be disclosed; to appropriate
state or local health departments to report certain communicable diseases;
to the State Cancer Registry to report cases of cancer where the state
has a legal reporting program providing for the information's confidentiality;
to private contractors assisting NIOSH; to collaborating researchers under
certain limited circumstances to conduct further investigations; to one
or more potential sources of vital statistics to make a determination
of death; to the Department of Justice in the event of litigation, and
to a congressional office assisting individuals in obtaining their records.
An accounting of the disclosures that have been made by NIOSH will be
made available to you upon request. Except for these and other permissible
disclosures expressly authorized by the Privacy Act, or in limited circumstances
when required by the Freedom of Information Act, no other disclosure may
be made without your written consent.
IV. SIGNATURES
I have read this consent form and I agree to participate in this study.
PARTICIPANT _____________________________ DATE _______
(Signature)
I, the SBCCOM representative, have accurately described this collaborative
study to the participant.
REPRESENTATIVE ___________________________ DATE ______
(Signature)
REQUEST AND AUTHORIZATION FOR RELEASE OF INFORMATION
I request and permit the project officer or attending physician to inform
the following physicians or health care facilities (whose names and addresses
I have entered below) of any significant findings from this study that
concern me. (Do not leave blank. Write "No" where you do not
wish to give a name and address.)
1. My personal physician(s):
Dr. _____________________________________
Street ____________________________________
City State Zip_________
2. Other physician or health care facilities:
Name ____________________________________
Street ____________________________________
City State Zip ________
Date
Participant
1 copy to participant
1 copy to project officer
Document B
Laboratory Respiratory Protection Level Quantitative Fit Test
NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH (NIOSH)
CENTERS FOR DISEASE CONTROL AND PREVENTION
U.S. PUBLIC HEALTH SERVICE
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
AND
SOLDIERS AND BIOLOGICAL CHEMICAL COMMAND (SBCCOM)
U.S. ARMY
CONSENT TO PARTICIPATE IN A RESEARCH STUDY
----------------------------------------------------------------------
You have been asked to participate in a joint NIOSH
and SBCCOM research study. We explain here the
nature of your participation, describe your rights, and
specify how NIOSH and SBCCOM will treat your records.
----------------------------------------------------------------------
I. DESCRIPTION
1. Project Title: "LABORATORY RESPIRATOR PROTECTION LEVEL TEST QUANTITATIVE
(MEDIUM-FLOW DEEP PROBE CORN OIL) PERFORMANCE TEST FOR RPD WITH FULL FACEPIECES
STANDARD TESTING PROCEDURE (STP)"
Document B: Quantitative Laboratory Respirator Protection Level Test
2. Sponsor and/or Project Officer: This project is a collaborative study
by NIOSH and SBCCOM with Co-Project Officers:
Alex G. Pappas, SBCCOM Mask Fit Test Facility Manager
3. Purpose and Benefits: The purpose of our overall study is to evaluate
and certify respiratory protective devices, to make sure they are safe
and work properly. The purpose for this test is to determine if the respirator
meets the performance test requirements listed in the regulations.
Information generated by this research project will benefit:
a. you, the participant, by providing a better understanding of respirators
and their performance. Also, you will receive a free annual medical
examination if you qualify to participate in the testing program.
b. workers who routinely use this same type of respirator, by ensuring
that respirators in the field perform as they were certified by NIOSH
to perform, and thus provide the expected level of respiratory protection.
c. those involved in testing, certifying, and manufacturing respirators
by providing feedback on how respirators perform in the field.
e. workers such as HazMat responders, firemen and mine rescue personnel
for protection against terrorism agents, toxic compounds and oxygen
deficiency.
II. CONDITIONS OF THE STUDY
1. Laboratory Respirator Protection Level Quantitative Fit Tests
--
Before the tests begins, you will be asked a few questions to make sure
you can safely perform the required activities of this test. You will
be asked if you have any serious illnesses or injuries or chronic pain
associated with the body movements to be performed during this test. You
will not be allowed to participate in this testing if you cannot safely
perform the required tasks.
During the testing, you will wear a full facepiece for a self-contained
breathing apparatus equipped with high efficiency 100-series particulate
air filters that is being evaluated by NIOSH. The tests which you will
be doing include various movements like those commonly performed in various
industries by a person wearing a respirator.
The test, a quantitative fit test, uses a corn oil mist. This test is
designed to evaluate the respirator's ability to achieve a good fit to
the user's face.
You will be given a respirator and asked to don it according to the manufacturer's
instructions. The investigator will help you. If appropriate, you will
then be asked to perform a facepiece seal check on the respirator, again
according to the manufacturer's instructions. The investigator will show
you the proper methods for donning and testing the respirator.
The fit test will last about 45 minutes at most.
1.a. Corn Oil Quantitative Fit Test --
NIOSH and SBCCOM use corn oil aerosol because it is easy to measure and
non-toxic.
When you are asked to perform the corn oil test, you will don a respirator,
wear it for about 20-30 minutes, enter a chamber containing a low concentration
(about 15 to 40 milligrams per cubic meter) of corn oil, and perform the
following movements:
(1) one minute normal breathing;
(2) one minute deep breathing;
(3) one minute turn head side to side;
(4) one minute move head up and down;
(5) one minute reciting the Rainbow Passage;
(6) one minute sight the rifle;
(7) one minute reach for the floor and ceiling;
(8) one minute on hands and knees, turning head side to side;
(9) one minute making facial expressions;
(10) one minute climbing the stairs at regular pace;
(11) one minute normal breathing.
The investigator will demonstrate the above activities to you. Actual
corn oil testing will last about 15 minutes (11 minutes for activities
and 4 minutes of instrument calibrations). We will be comparing the corn
oil measurements in the chamber with the corn oil measurements inside
the respirator using a measuring probe in the face of the respirator.
If the respirator is working, there should be very little corn oil inside
the respirator compared to the chamber. If the investigator determines
the respirator is not working properly, the test will be stopped. You
may then be asked to adjust the respirator and do the test over.
The corn oil is similar to products you buy at the store and cook with
every day. The amount of corn oil in the chamber will range from 15-40
milligrams per cubic meter of air. The amount inside the respirator should
be much less than that, around 0.31 milligrams per cubic meter. NIOSH
has said that exposure to corn oil at 10 milligrams per cubic meter can
be a nuisance. The test will be stopped if the levels of corn oil in the
respirator reach 10 milligrams per cubic meter. Corn oil has no known
toxic properties.
2. During testing, you might experience slightly higher breathing resistance
than you are normally used to. You may also experience slight discomfort
from the facepiece, nosecup, and uncomfortable harnesses or belts.
3. No other test procedures can be substituted for the Laboratory Respirator
Protection Level Quantitative Fit Test.
4. The procedures for the Laboratory Respirator Protection Level Quantitative
Fit Test will be clearly explained in detail before the testing is started.
Feel free to ask any questions.
5. If you have any reaction to the medical screening procedures, you
should contact Mr. Alex G. Pappas, Mask Fit Test Facility Manager, SBCCOM
(410-436-3338).
6. Injury from this project is unlikely. But if injury occurs, medical
care, other than emergency treatment, will not be provided. If you are
injured during testing through negligence of a SBCCOM or NIOSH employee,
you may be able to obtain compensation under Federal Law. If you want
to file a claim against the federal government your contact point is:
Public Health Service Claims Office (301) 443-1904. If you are injured
through the negligence of a NIOSH contractor, your claim would be against
the contractor, not the federal government.
Any serious incident of adverse reaction that should arise during the
conduct of this study at SBCCOM will be reported within one hour to Timothy
Williams, CIH, CSP, Master Industrial Hygienist and SBCCOM Human Use Chairman
at (410) 436-2302.
If you are injured during testing, you should also contact: Mr. Alex
G. Pappas, Mask Fit Test Facility Manager, SBCCOM (410-436-3338) and Dr.
Michael J. Colligan, Chairperson, NIOSH Human Subjects Review Board (513)
533-8222.
7. If you have questions about this research, contact: Mr. Alex G. Pappas,
Mask Fit Test Facility Manager, SBCCOM (410-436-3338) . If you have questions
about your treatment or rights as a member of this study, contact: Michael
J. Colligan, Ph.D., Chair, NIOSH Human Subjects Review Board at (513)
533-8222; or Timothy Williams, CIH, CSP, Master Industrial Hygienist and
SBCCOM Human Use Chairman at (410) 436-2302.
8. Your participation is voluntary and you may withdraw your consent
and your participation in this study at any time without penalty or loss
of benefits to which you are otherwise entitled.
You will receive $25.00 per test per visit or partial visit that you
participate in this study.
9. Overall results of the testing of the respirators will not contain
information useful to you personally. In addition, the results contain
certain trade secrets and confidential design operation information that
NIOSH and SBCCOM do not release to the public. Because of this, we cannot
directly provide you with the overall study testing results. However,
the test report with all personal identifiers and trade secret information
removed would be available upon written request under the Freedom of Information
Act, 5 U.S.C. 552. Send your written request to:
Freedom of Information Act Officer
Centers for Disease Control and Prevention
1600 Clifton Road
Atlanta, Georgia 30337
III. USE OF INFORMATION
The National Institute for Occupational Safety and Health
(NIOSH) of the Centers for Disease Control and Prevention (CDC), an agency
of the Department of Health and Human Services, is authorized to collect
this information, including your social security number (if applicable),
under provisions of the Public Service Act, Section 301 (42 U.S.C. 241);
Occupational Safety and Health Act, Section 20 (29 U.S.C. 669); and the
Federal Mine Safety and Health Act of 1977, Section 501 (30 U.S.C. 95).
The information you supply is voluntary and there is no penalty for not
providing it.
The data will be used to assess the performance of various
respiratory protective devices, to make sure they are safe and work properly.
Data will become part of CDC Privacy Act system 09-20-0159 "Records
of Subjects in Certification, Testing, Studies of Personal Protective
Devices, and Accident Investigations" and may be disclosed; to appropriate
state or local health departments to report certain communicable diseases;
to the State Cancer Registry to report cases of cancer where the state
has a legal reporting program providing for the information's confidentiality;
to private contractors assisting NIOSH; to collaborating researchers under
certain limited circumstances to conduct further investigations; to one
or more potential sources of vital statistics to make a determination
of death; to the Department of Justice in the event of litigation, and
to a congressional office assisting individuals in obtaining their records.
An accounting of the disclosures that have been made by NIOSH will be
made available to you upon request. Except for these and other permissible
disclosures expressly authorized by the Privacy Act, or in limited circumstances
when required by the Freedom of Information Act, no other disclosure may
be made without your written consent.
IV. SIGNATURES
I have read this consent form and I agree to participate in this study.
PARTICIPANT _____________________________ DATE __________
(signature)
I, the SBCCOM representative, have accurately described this study to
the participant.
REPRESENTATIVE ___________________________ DATE __________
(signature)
|