Approvals: First Level Second Level Third Level Fourth Level

National Institute for Occupational Safety and Health

National Personal Protective Technology Laboratory

P.O. Box 18070

Pittsburgh, PA 15236

Procedure No. TEB-CCER-STP-0612 Revision: 0.0 Date: 7 April 2014

DETERMINATION OF CAPACITY OF CLOSED-CIRCUIT ESCAPE RESPIRATORS (CCER) WITH 

HUMAN SUBJECTS ON TREADMILL

1. PURPOSE

This procedure describes the standard test with human subjects for ensuring that the level of 

protection provided by the capacity on Closed-Circuit Escape Respirators (CCER) submitted for 

Approval, Extension of Approval, or examined during Certified Product Audits, meet the 

minimum certification standards set forth in Section 84.303 and 84.304, of Subpart O−Closed 

Circuit Escape Respirators updated requirements to 42 CFR, Part 84, Volume 60, Number 110, 

June 8, 1995 as published in Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Rules 

and Regulations pp. 14168-14197.

2. GENERAL

This STP describes both the procedure for Human Subject Capacity Test of CCERs in sufficient 

detail such that a person knowledgeable in the appropriate technical field can select equipment 

with the necessary resolution, conduct the procedure, and determine whether or not the product 

passes the test.

3. EQUIPMENT AND MATERIALS

3.1. The measurement instruments used must be capable of breath-by-breath response and 

have the following measurement ranges:

3.1.1. Gas analyzer with resolution of 0.1% gas concentration, and range of 0-10% 

CO2, and 0-100% O2;

3.1.2. Pressure transducer with a readout range of -400 to +400 mm H2O and resolution

of 1millimeter H2O

3.1.3. Wet and dry-bulb thermometers with resolution of 0.1°C, range 0-100°C

3.2. The equipment necessary to perform the capacity test is as follows:

3.2.1. Doric Series Doric Series 400A Standard Resolution Digital Temperature 

indicator or equivalent

3.2.2. Temperature Compensated pressure (Validyne Engineering Model No. DP45) 

with digital readout or equivalent
Procedure No. TEB-CCER-STP-0612 Revision: 0.0 Date: 7 April 2014 Page 2 of 8

3.2.3. Multi-channel (≥4) strip chart recorder, digital data display, or equivalent

3.2.4. Bench top electric timer, calibrated to 100ths (0.01) of a minute or equivalent

3.2.5. Handheld timer, digital stopwatch calibrated to100ths (0.01) of a minute or 

equivalent

3.2.6. Applied Electrochemistry CO2 Analyzer - Model CD-3A or equivalent

3.2.7. Applied Electrochemistry Oxygen Analyzer - Model S-3A/I or equivalent

3.2.8. Manometer -400 to 400 mm H2O, or equivalent

3.2.9. Model 18-49B Horizontal Treadmill, 0-6 MPH, or equivalent

4. PROCEDURE REQUIREMENTS AND CONDITIONS

4.1. Test subjects must meet requirements of the NIOSH Human Subject Review Board 

(HSRB) approved Protocol. Refer to “Protocol for tests with human subjects of closedcircuit breathing apparatus in certification, quality assurance, and development” HSRB 

12-NPPTL-04 for the proper consent form and complete details on the use of human test 

subjects in respirator certification testing.

4.2. All measuring equipment and instruments to be used must have been calibrated using a 

method traceable to the National Institute of Standards and Technology (NIST) in 

accordance with the manufacturer's calibration procedure and schedule.

4.3. Any laboratory using this procedure to supply certification test data to NPPTL will be 

subject to the provisions of the NPPTL 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 NPPTL. 

4.4. Normal laboratory safety practices must be observed. These include safety precautions 

given in the current NIOSH-Pittsburgh Health and Safety Manual, Job Hazard Analysis 

(JHA), work instruction documents and test equipment manufacturer recommended 

practices.

4.5. Refer to “Protocol for tests with human subjects of closed-circuit breathing apparatus in 

certification, quality assurance, and development” HSRB 12-NPPTL-04 for the consent 

form and complete details on the use of human test subjects in respirator certification 

testing.

4.6. Prior to performing the capacity test with human subjects on a treadmill as described in 

this procedure, all tests with a breathing and metabolic simulator (BMS) required for 

certification must have been completed and all BMS tests must have been passed.
Procedure No. TEB-CCER-STP-0612 Revision: 0.0 Date: 7 April 2014 Page 3 of 8

4.7. From the BMS test results determine the following using the Standard Procedure for the 

Assessment of Stressors during CCER Capacity, Performance and Wearability Tests with 

Human Subjects:

4.7.1. The differences between average inhaled and end-of-inhalation gas 

concentrations (∆CO2 and ∆O2) using the Calculation of average inhaled gas 

concentrations from end-of-inhalation gas concentrations.

4.7.2. The values required for the Calculation of average inhaled gas concentrations 

from end-of-inhalation gas concentrations shall not exceed acceptable range 

throughout test.

4.8. Prior to performing the capacity test with human subjects on a treadmill use Standard 

Operating Procedure for Human-Subject Oxygen Demand (VO2) Determination (TEBCCER-SOP-0616) with the specific subject to establish treadmill speed and inclination 

needed for the VO2 to be used in the test as shown in Table 1.

4.9. Conduct all procedures at the following ambient conditions:

4.9.1. Ambient temperatures of 23oC ± 3oC; and

4.9.2. Atmospheric pressures of 735 mm Hg ± 15 mm Hg.

4.10. Prior to performing the test, each subject will receive training in how to don, operate and 

doff the CCER.

4.10.1. The training will cover procedures indicated and/or recommended in the CCER 

instructions:

4.10.1.1. As contained in one or more of the following required topics: 

4.10.1.1.1. Procedures for donning and use (§ 84.302 (h) (1) (iii)

4.10.1.1.2. Procedures for inspecting the operating condition of the 

CCER (§ 84.302 (h) (1) (iv)

4.10.1.1.3. Any procedure by which the user should inspect the CCER 

and determine when the CCER should be removed from use (§ 

84.302 (h) (2) (iii)

4.10.2. Training may involve use of a training unit(s).

4.10.3. Each unit will be tested at a constant work rate which depends on the capacity 

specified by the manufacturer, according to the requirements in Table 1.
Procedure No. TEB-CCER-STP-0612 Revision: 0.0 Date: 7 April 2014 Page 4 of 8

Table 1: Capacity Test Requirements (All volumes are given at standard temperature (0°C) and 

pressure (760 mm Hg), dry) 

Capacity

Rating

Capacity

(L)

.

V

O2 

(L/min)

Cap 1 20 ≤ L ≤ 59 2.50

Cap 2 60 ≤ L ≤ 79 2.00

Cap 3 L ≥ 80 1.35

.

V

O2=volume of oxygen consumed/min 

4.11. The capacity test with human subject is conducted on one unit submitted for approval in 

the ‘as received’ condition. 

4.12. Throughout Capacity test the stressors are measured at the interface between the CCER 

and the subject’s mouth by instruments capable of breath-by-breath measurement and 

continuously recorded on a multichannel strip chart recorder, digital data display, or 

equivalent. 

4.12.1. Using the Standard Procedure for the Assessment of Stressors during CCER 

Capacity and Performance Tests with Human Subjects, perform the following: 

4.12.1.1. Determine each stressor measurement as one-minute average and 

evaluate against the acceptable range excursion in Table 2. 

4.12.1.2. For each stressor estimate the interim operating (overall) averages and 

evaluate against the acceptable range overall in Table 2. 

Table 2: Monitored Stressors and their Acceptable Ranges 

Stressor Acceptable Range

Overall Test Average

Acceptable Range

Excursion

for one-minute average

Average inhaled CO2 <1.5% ≤4%

Average inhaled O2 >19.5% ≥15%

Peak Breathing

Pressures

∆P ≤ 200 mm H2O -300 ≤ ∆P ≤ 200 mm H2O

Wet-bulb temperature <43 ̊C ≤50 ̊C

4.12.2. At the end of the test calculate the operating (overall) average of each stressor as 

the average of the one-minute measurements of the stressor recorded during the 

test. 

5. PROCEDURE 

5.1. Prepare CCER unit for test: 

5.1.1. The CCER will be opened and visually inspected using manufacturer’s and 

NIOSH inspection criteria. This inspection will include: 
Procedure No. TEB-CCER-STP-0612 Revision: 0.0 Date: 7 April 2014 Page 5 of 8

5.1.1.1. Applying a -300mm H2O vacuum to assess the integrity of the 

breathing tube and associated parts.

5.1.1.2. A phenolphthalein swab to detect alkaline chemicals present in the 

CCER user interface.

5.1.2. Mount instrument sampling lines and thermocouples into apparatus mouthpiece 

(or proximally in breathing tube).

5.2. Prepare instruments for test:

5.2.1. Calibrate the gas analyzers using certified calibration gas with O2 at 80.0 % and 

CO2 at 8.0% and N2 at 12%. 

5.2.2. Ensure that instruments values displayed on chart recorder correlate with 

instrument readings.

5.2.3. Note the excursion limits for the stressors on the chart recorder scale.

5.2.3.1. Apply the differences calculated in 4.6.1 for oxygen and carbon 

dioxide.

5.3. Human subjects

5.3.1. Perform all instruction required in protocol.

5.3.2. Use consent form and procedures included in HSRB 12-NPPTL-04 for the 

capacity test.

5.4. Begin capacity test:

5.4.1. Set treadmill speed and inclination to the values required to achieve the work rate 

appropriate for the CCER Capacity rating in Table 1.

5.4.2. Subject dons CCER.

5.4.2.1. Chart recorder paper drive is started.

5.4.2.2. Subject begins walking on treadmill belt.

5.4.2.3. Remind subject that they can stop the test at any time.

5.5. The stressors listed in Table 2 are continuously monitored and recorded throughout the 

capacity test, using the Standard Procedure for the Assessment of Stressors during CCER 

Capacity, Performance and Wearability Tests with Human Subjects:

5.5.1. Values for each stressor are averaged over each minute of test.

5.5.2. The resulting one-minute average value(s) is compared to the excursion(s) listed 

in Table 2.
Procedure No. TEB-CCER-STP-0612 Revision: 0.0 Date: 7 April 2014 Page 6 of 8

5.5.3. The interim operating average of each stressor is compared to the operating 

average listed in Table 2.

5.5.4. If any one-minute average measurement meets or exceeds an excursion limit 

listed in Table 2, the test is stopped.

5.6. In addition, NIOSH will also continuously monitor CCER use by each test subject during 

the activities specified in Table 1 and evaluate the ability of the CCER to provide an 

adequate and uninterrupted breathing supply without harming or hindering a user.

5.7. The subject stops the test and doffs the CCER when apparatus oxygen supply is depleted 

or if the subject cannot continue for subjective reasons.

5.7.1. The depletion of apparatus oxygen supply which is usually indicated by the one 

minute average of peak breathing pressure, ∆P, falling below -300 mm H2O, or 

by manufacturer instructions for indication of the end of breathing gas supply.

5.8. After test is stopped:

5.8.1. Stop chart recorder paper drive.

5.8.2. Let gas sample pump operate until water droplets are no longer present in lines 

preceding gas dryer.

5.8.3. Determine the completion time as the time elapsed from test start to when the 

oxygen supply is expended.

5.8.4. Calculate the overall average for each of the stressor measurements using the 

one-minute average values from the test start to when the oxygen supply is fully 

expended.

6. PASS/FAIL CRITERIA

6.1. The apparatus fails this test and certification if:

6.1.1. If from the test start up to when the gas supply is fully expended any one-minute 

average stressor measurement is outside the acceptable excursion range shown in 

Table 2 (last column).

6.1.2. Any average stressor measurement (as the overall average from test start to when 

the gas supply is fully expended) is outside the acceptable operating average 

range shown in Table 2 (middle column).

7. RECORDS AND TEST SHEETS

None

8. ATTACHMENTS
Procedure No. TEB-CCER-STP-0612 Revision: 0.0 Date: 7 April 2014 Page 7 of 8

None
Procedure No. TEB-CCER-STP-0612 Revision: 0.0 Date: 7 April 2014 Page 8 of 8

Revision Date Reason for Revision

0.0 Initial record

1.0 18 August 2011 Review

2.0 20 August 2012 Administrative changes – changed document number

3.0 10 April 2012 Administrative changes were made to include information from the 

release of the proposed rule.

Former document number - STP-00001-PSDB-0024

0.0 7 April 2014 New document number to reflect numbering in the approval library, 

normalization of format. No changes to procedure from historical 

document.