September 30, 2003 

Attachment A 

Statement of Standard 

For 

Chemical, Biological, Radiological, and Nuclear (CBRN) 

Air-Purifying Escape Respirator 

1.0 Purpose: 

The purpose of this standard is to specify minimum requirements to determine the 

effectiveness of air-purifying escape respirators that address CBRN materials identified 

as inhalation hazards from possible terrorist events for use by the general working 

population. The air-purifying escape respirator must meet the minimum requirements 

identified in the following Paragraphs: 

•	 Paragraph 2.0, Requirements Specified in Title 42, Code of Federal 

Regulations (CFR), Part 84 applicable paragraphs, 

•	 Paragraph 3.0, Requirements based on existing national and international 

standards, 

•	 Paragraph 4.0, Special requirements for CBRN use. 

2.0 Title 42 Code of Federal Regulations (CFR), Part 84: 

The following paragraphs of 42 CFR, Part 84 are applicable: 

2.1 42 CFR, Part 84, Subparts A, B, D, E, F, and G: 

Subpart A: General Provisions 

Subpart B: Application for Approval 

Subpart D: Approval and Disapproval 

Subpart E: Quality Control 

Subpart F: Classification of Approved Respirators 

Subpart G: General Construction and Performance 

3.0 Requirements Based on Existing National and International Standards: 

3.1 Breathing Resistance: 

The resistance of airflow shall be measured at the breathing zone (nose cup or 

mouthpiece) of an air-purifying escape respirator mounted on a head form test apparatus 

operated at a continuous airflow rate of 85 Liters per minute (Lpm). The inhalation 

resistance shall not exceed 70 mm H2O and the exhalation resistance shall not exceed 20

 mm H2O. 
3.2 Field of View: 

The air-purifying escape respirator shall obtain a Visual Field Score (VFS) of 70 or 

greater when tested in accordance with NIOSH Standard Test Procedure CET-APRSSTP-CBRN-0314. The VFS shall be obtained by using a medium size respirator or 

equivalent that is sized to fit the Head Form described in Figure 14 of EN 136, 

Respiratory protective devices – Full face masks – Requirements, testing, marking; 

January 1998 or equivalent. 

The VFS is determined by using a VFS grid (Dots on visual field) as defined in the 

American Medical Association Guides to the Evaluation of Permanent Impairment, 

5th Edition (2000) that is overlaid on the diagram of the visual field plot obtained using 

the spherical shell of EN 136 apertometer or equivalent. The VFS score is the average of 

three fittings of the same respirator on the specified head form. 

3.3 Fogging: 

The air-purifying escape respirator shall demonstrate an average Visual Acuity Score 

(VAS) of greater or equal to 70 points for all measurements for each individual. A 

minimum of two respirators shall be evaluated. 

The respirator shall be donned by the test subject in an indoor ambient temperature of 

approximately 72+20 F at 40+5% Relative Humidity (RH) and then shall enter into a 

simulated outdoor extreme temperature chamber where the visual acuity tests shall be 

administered. The air-purifying escape respirator shall be tested for fogging in the 

hot/humid condition of 90+20F and 60+5% RH, and the cold condition of 13+20F. 

3.4 Breathing Gas: 

Breathing gas criteria will be evaluated as a two-part requirement: 1) a dead-space carbon 

dioxide test performed with a breathing machine and 2) carbon dioxide and oxygen 

concentrations during human test subject exercises. The wearer shall not experience 

undue discomfort because of restrictions to breathing or other physical or chemical 

changes to the respirator. All trials shall be considered as part of the Practical 

Performance criteria of paragraph 4.8. 

3.4.1 Breathing Machine 

The maximum allowable average inhaled carbon dioxide concentration shall be less than 

or equal to 1 percent, measured at the mouth, while the air-purifying escape respirator is 

mounted on a dummy head operated by a breathing machine. The breathing rate will be 

14.5 respirations per minute with a minute volume of 10.5 Liters. Tests will be 

conducted at ambient temperature of 25 ± 5°C. A concentration of 5 percent carbon 

dioxide in air will be exhaled into the facepiece. The minimum allowable oxygen 

concentration shall be that of the ambient room oxygen concentration. NIOSH Test 

Procedure RCT-APR-STP-0064 is used for carbon dioxide testing. 

2
 
3.4.2 Human Subject Testing 

During the testing required by this section, the concentration of inspired carbon dioxide 

gas at the mouth will be continuously recorded, and the calculated maximum range 

concentration during the inhalation portion of the breathing cycle shall not exceed the 

limits as stated in Table 1. 

Table 1.—Inspired carbon dioxide limits 

Maximum time-weighted fractional concentration of Where the service time is inspired carbon dioxide 

15 min or 30 min 0.025 (or 2.5%) 

45 min or 60 min 0.020 (or 2.0%) 

The inhaled carbon dioxide concentration shall be as indicated in the above table. The 

inhaled fractional oxygen concentration shall be no less than 0.195 (or19.5%) when 

tested with human subjects at the following work rates: standing and walking at 3.5 miles 

per hour. Two tests (standing and walking at 3.5 miles per hour) shall be performed, 

each using 12 test subjects. Table 2 gives face length and width criteria, which the 

subjects will be required to fill. Table 2 is applicable for ‘one size fits all air-purifying 

escape respirator’ or an air-purifying escape respirator with small, medium and large 

sizes. For other variations in air-purifying escape respirator size, test subjects will be 

determined to provide for panel range of Table 2. 

Table 2.—Test design criteria 

*LANL Boxes – ‘Small’ *LANL Boxes – ‘Medium’ *LANL Boxes – ‘Large’ 

1, 2, 3, 4 3, 4, 5, 6, 7, 8 7, 8, 9, 10 

Four subjects in ‘Small’ 

boxes. More than one 

subject possible in any 

box. 

Four subjects in ‘Medium’ 

boxes. More than one 

subject possible in any box. 

Four subjects in ‘Large’ 

boxes. More than one 

subject possible in any box. 

*Adapted from the Los Alamos National Laboratory report respirator test panel 

Each exercise will be performed for 10 minutes. Carbon dioxide and oxygen data will be 

considered for the last 5 minutes of each exercise. For each of these last 5 minutes, the 

last 5 breaths will be considered. 

For each group of 12 subjects, 95% of the total number of trials must meet the stated 

criteria. Should a group of test trials not pass the 95% of trials, one addition run of test 

trials consisting of 12 test subjects may be performed to increase the total number of 

trials; the total number of trials (total of 48) will be the sum of trials from the first and 

second run of subjects. All trials shall be considered in the Practical Performance 

requirement criteria of paragraph 4.8. 

3
 
 

3.5 Flammability and Heat Resistance (applicable ONLY to respirators approved 

for carbon monoxide protection): 

Air-purifying escape respirators submitted for approval for carbon monoxide protection shall 

be tested for Flammability and Heat Resistance using the test equipment specified in EN 136, 

Respiratory Protective Devices, Full Face Masks, Requirements, Testing, Marking, 1998 

Edition, Class 1 facepiece. No component of the respirator shall have an after flame after 5 

seconds. No component of the escape respirator shall drip, melt, or develop a visible hole. 

The distance between the outer surface of the escape respirator and the burner shall be 

adjusted to 20 ± 2 mm. The pressure reducer shall be adjusted to 2.1 ± .05 psi. The 

temperature of the flame positioned above the burner tip shall be 800 ± 500

 C at a point 20+2 mm 

above the tip. The respirator shall be rotated once through the flame at a velocity of 6 ± 0.5 cm/s. 

Where components of the respirator such as valves, filters, etc. are arranged on the respirator, 

the test shall be repeated with these components at the appropriate height of 250 mm ± 6.4 mm. 

3.6 Design Considerations:

 3.6.1 Function: 

The air-purifying escape respirator shall provide a barrier from ambient conditions for the 

wearer’s entire head, eyes, and respiratory system. The air-purifying escape respirator 

shall not require the use of hands to maintain the respirator position to ensure proper 

function of the respirator when fully donned. 

3.6.2 Hood Type Device: 

The air-purifying escape respirator shall be designed as a hooded device. The hood shall 

include an area for field of vision. A hood is a respirator component which covers the 

wearer’s head and neck, or head, neck, and shoulders, and is supplied with incoming 

respirable air for the wearer to breathe. 

3.6.3 Respiratory Protection System: 

The respiratory protection system may consist of an oral/nasal cup or mouthpiece. If a 

mouthpiece is employed, a method of preventing nasal breathing must be provided. An 

oral/nasal cup or a mouthpiece is not required provided all requirements of this standard 

are fulfilled by the air-purifying escape respirator. 

4.0 Special CBRN Requirements: 

4.1 Duration Rating: 

Escape respirators will be rated for 15, 30, 45, or 60-minute duration as specified by the 

manufacturer. Only one duration rating can apply to any respirator. 

4
 
4.2 Canister Test Challenge and Test Breakthrough Concentrations. 

4.2.1 General Category 

Escape respirators shall meet the gas/vapor test challenge concentrations in Table 3, 

when tested in accordance with 4.3 Gas Life requirements. 

Table 3.—Gas/vapor test challenge concentrations 

Agent Test Challenge(ppm) Breakthrough (ppm) 

Ammonia 1250 25 

Cyanogen Chloride 150 2 

Cyclohexane 1300 10 

Formaldehyde 250 10 

Hydrogen Cyanide 470 10* 

Hydrogen Sulfide 500 30 

Nitrogen Dioxide 100 1 ppm NO2 

Phosgene 125 1.25 

Phosphine 150 0.5 

Sulfur Dioxide 750 5 

* Sum of HCN and C2N2 

4.2.1.1 General Category Escape Respirator Multi Gas/Vapor/Particulate with 

Carbon Monoxide Requirements: 

Escape respirators intended for use at the General category with carbon monoxide 

protection shall meet the requirements of paragraph 4.2.1 plus carbon monoxide. 

For the general category, the test challenge concentration shall be 3600 ppm. The 

maximum allowable carbon monoxide penetration shall not exceed the values 

identified in the Table 4. The penetration of carbon monoxide shall not exceed a 

maximum peak excursion of 500 ppm at any point of the test. 

Table 4.—Carbon monoxide penetration limits 

Identified Service Life (Minutes) Concentration-time(Ct) (ppm-minutes_ 

15 6037 

30 12075 

45 18111 

60 24150 

The respirators will be evaluated under the following test conditions: 

a) Three respirators tested at 64+10 Lpm continuous airflow at 89 to 95% relative 

humidity, 25+30C 

b) Three respirators tested at 64+10 Lpm continuous airflow at 89 to 95% relative 

humidity, 0+2.50

C 

5
 
 

 

4.2.1.1.1 Service Life Testing, High Flow, Carbon Monoxide: 

The escape respirator shall provide a minimum duration of 5 minutes when tested at a 

flow rate of 100+10 Lpm, 89 to 95% relative humidity, 25+30

C, when tested at a 

challenge concentration of 3600 ppm. The penetration of carbon monoxide shall not 

exceed a maximum peak excursion of 500 ppm at any point of the test. The maximum 

allowable carbon monoxide penetration shall not exceed an overall Ct of 2013 ppmminutes. Three respirators will be tested. 

4.2.1.1.2 Inspired Air Temperature, Carbon Monoxide: 

Three escape respirators mounted to a head form and connected to a breathing machine, 

cycling at 40Lpm, 36 respirations per minutes, 1.1 Liters tidal volume, will be tested with 

a challenge concentration of 1200 ppm (IDLH), at 89 to 95% relative humidity and 

25+2.5o

C. The inspired air temperature measured at the facepiece must always be less 

than or equal to 460

C (dry bulb) with less than or equal to 10 ppm CO for the entire test if 

the inspired air humidity is less than or equal to 50%. The inspired air temperature must 

be less than or equal to 410C (dry bulb) with less than or equal to 10 ppm CO for the 

entire test if the inspired air relative humidity is greater than 50%. NIOSH test procedure 

RCT-APR-STP-0034 will be used. 

4.2.2 Specific Category: 

Escape respirators intended for use at the specific hazard threat category conditions shall 

meet the gas/vapor testing of paragraph 4.2.1. In addition to the test requirements of 

paragraph 4.2.1, test concentrations for additional specific test agent protections shall be 

as specified in Table 5. 

Table 5.—Agent challenge concentrations 

Agent Test Challenge (ppm) 

Ammonia 2500 

Cyanogen Chloride 300 

Cyclohexane 2600 

Formaldehyde 500 

Hydrogen Cyanide 940 

Hydrogen Sulfide 1000 

Nitrogen Dioxide 200 

Phosgene 250 

Phosphine 300 

Sulfur Dioxide 1500 

Additional specific test agent protections can be added to the minimum as specified by 

the applicant for any combination of the listed test agents. Test breakthrough 

concentrations for the specific category shall be the breakthrough concentrations 

identified in paragraph 4.2.1. 

6
 
 

4.2.2.1 Specific Category Escape Respirator Multi Gas with Carbon Monoxide 

Requirements: 

Escape respirators intended for use at the Specific category with carbon monoxide 

protection shall meet the requirements of paragraph 4.2.2 for the requested test agent 

protection, plus carbon monoxide. 

For the specific category, the carbon monoxide test challenge concentration shall be 6000 

ppm. The maximum allowable carbon monoxide penetration shall not exceed the values 

identified in paragraph 4.2.1.1 and Table 4. 

4.2.2.1.1 Service Life Testing, High Flow, Carbon Monoxide: 

The escape respirator shall provide a minimum duration of 5 minutes when tested at a 

flow rate of 100+10 Lpm, 89 to 95% relative humidity, 25+30C, when tested at a 

challenge concentration of 6000 ppm. The penetration of carbon monoxide shall not 

exceed a maximum peak excursion of 500 ppm at any point of the test. The maximum 

allowable carbon monoxide penetration shall not exceed a Ct of 2013 ppm-minutes. 

Three respirators will be tested. 

4.2.2.1.2 Inspired Air Temperature, Carbon Monoxide: 

Three systems mounted to a head form and connected to a breathing machine, cycling at 

40 Lpm, 36 respirations per minute, 1.1 Liters tidal volume, will be tested with a 

challenge concentration of 1200 ppm IDLH (IDLH) at 89 to 95% relative humidity and 

25+2.5o

C. The inspired air temperature measured at the facepiece must always be less 

than or equal to 460C (dry bulb) and less than or equal to 10 ppm CO for the entire test 

if the inspired air humidity is less than or equal to 50%. The inspired air temperature 

must be less than or equal to 410C (dry bulb) and less than or equal to 10 ppm CO for 

the entire test if the inspired air relative humidity is greater than 50%. NIOSH test 

procedure RCT-APR-STP-0034 will be used. 

4.3 Gas Life: 

Gas life tests are performed at room temperature, 25"50

C; 25"5 percent relative 

humidity, and 80"5 percent relative humidity. Three filters will be tested at each 

specified humidity with a flow rate of 64+10 Lpm, continuous flow. Tests will be 

conducted to minimum specified service time. Gas testing shall be performed following 

environmental conditioning and rough handling. The breakthrough concentration must 

be no greater than the specified breakthrough for each tested gas in Table 3. Testing is 

terminated after the applicant’s specified service time is achieved. 

4.4 Particulate/Aerosol Canister: 

The canister shall meet the requirements of a P100 particulate filter in accordance with 

the following criteria of 42 CFR, Part 84. 

7
 
1) Twenty filters for the air-purifying respirator shall be tested for filter efficiency against 

a dioctyl phthalate or equivalent liquid particulate aerosol. 

2) Filters 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. 

3) When the filters do not have separable holders and gaskets, the exhalation valves shall 

be blocked so as to ensure that leakage, if present, is not included in the filter efficiency 

level evaluation. 

4) For air-purifying particulate respirators with a single filter, filters shall be tested at a 

continuous airflow rate of 85 + 4 liters per minute. Where filters are to be used in pairs, 

the test-aerosol airflow rate shall be 42.5 + 2 liters per minute through each filter. 

5) A neat cold-nebulized dioctyl phthalate (DOP) or equivalent aerosol at 25 + 5oC that 

has been neutralized to the Boltzmann equilibrium state shall be used. Each filter shall be 

challenged with a concentration not exceeding 200 mg/m3. 

6) The test shall continue until minimum efficiency is achieved or until an aerosol mass 

of at least 200 + 5 mg has contacted the filter. If the filter efficiency is decreasing when 

the 200 + 5 mg challenge point is reached, the test shall be continued until there is no 

further decrease in efficiency. 

7) The DOP aerosol shall have a particle size distribution with count median diameter of 

0.185 + 0.020 micrometer and a standard geometric deviation not exceeding 1.60 at the 

specified test conditions as determined with a scanning mobility particle sizer or 

equivalent. 

8) The efficiency of the filter shall be monitored and recorded throughout the test period 

by a suitable forward-light-scattering photometer or equivalent instrumentation. 

9) The minimum efficiency for each of the 20 filters shall be determined and recorded 

and be equal to or greater than the filter efficiency criterion listed for the P100 filter: 

>99.97%. 

4.5 Service Life Testing, High Flow: 

Each escape respirator shall provide a minimum duration of 5 minutes when tested at a 

flow rate of 100+10 Lpm, 50+5 percent relative humidity and 25+50

C for each of the 

gases/vapors identified in paragraphs 4.2.1 and 4.2.2. 

4.6 Chemical Agent Permeation and Penetration Resistance Against Distilled Sulfur 

Mustard (HD) and Sarin (GB) Agent Requirement: 

The air-purifying escape respirator system, including all components and accessories 

shall resist the permeation and penetration of Distilled Sulfur Mustard (HD) and Sarin 

(GB) chemical agents when tested on an upper-torso manikin connected to a breathing 

8
 
 

 

 

 

machine operating at an air flow rate of 40 Lpm, 36 respirations per minute, 1.1 Liters 

tidal volume. 

Test requirements for Distilled Sulfur Mustard (HD) are shown in Table 6. 

Table 6.—Vapor-Liquid Sequential Challenge of Air-Purifying Escape Respirator 

with Distilled Sulfur Mustard (HD) 

Agent Challenge Duration of Breathing Maximum Maximum Number Minimum 

Concentration Challenge Machine Peak Breakthrough of Test Time 

(min) Airflow 

Rate 

Excursion 

(mg/m3

) 

(concentration 

integrated 

Systems 

Tested 

(hours) 

(Lpm) over minimum 

service life) 

(mg-min/m3

) 

HDVapor 50 mg/m3* 15/30/45/60*,** 

HDLiquid 0.43 to 0.86 ml† 15/30/45/60*,** 40 0.60‡

 6.0§,‡‡ 3 30/60/90/120†† 

* Vapor challenge concentration will start immediately after the liquid drops have been applied and the test chamber 

has been sealed. 

†. Minimum volume is 0.43 ml based on the respirator and single canister. Liquid volume is applied as 25 drops of 

equal size. 

‡ Three consecutive sequential test data points at or exceeding 0.6 mg/m3 will collectively constitute a failure where 

each test value is based on a detector sample time of approximately 2 minutes. 

§ The cumulative Ct including all maximum peak excursion data points must not be exceeded for the duration of the 

test. 

** Duration of challenge is 15, 30, 45, or 60 minutes, equal to applicant’s identified rated duration (para 4.1) 

†† Minimum Test Life is 30, 60, 90, or 120 minutes, equal to twice the applicant’s rated duration (para 4.1) 

‡‡ Respirators will be monitored in the oral/nasal and ocular regions 

Test requirements for Sarin (GB) agent are shown in Table 7. 

9
 
 

Table 7.—Vapor Challenge of Air-Purifying Escape Respirator with Sarin (GB) 

Challenge Vapor Vapor 

Concentration Concentration Challenge 

(mg/m3

) Time 

(minutes) 

Breathing 

Machine 

Airflow 

Rate 

(Lpm) 

Maximum 

Peak 

Excursion 

mg/m3 

15/30/ GB 210 40 0.087‡ 

45/60*,** 

Maximum 

Breakthrough 

(concentration 

integrated 

over minimum 

service life) 

(mg-min/m3) 

0.9 for 15 and 

30 minute 

devices 

2.1 for 45 and 

60 minute 

devices§,‡‡ 

Number 

of 

Systems 

Tested 

Minimum 

Test Time 

(hours) 

30/60/ 3 90/120†,†† 

* 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. 

‡ Three consecutive sequential test data points at or exceeding 0.087 mg/m3 will collectively constitute a failure 

where each test value is based on a detector sample time of approximately 2 minutes. 

§ The cumulative Ct including all maximum peak excursion data points must not be exceeded for the duration of the 

test. The breakthrough duration is based upon the applicant’s identified duration. 

** Duration of challenge is 15, 30, 45, or 60 minutes, equal to applicant’s identified rated duration (para 4.1) 

†† Minimum Test Life is 30, 60, 90, or 120 minutes, equal to twice the applicant’s identified rated duration (para 

4.1). 

‡‡ Respirators will be monitored in the oral/nasal and ocular regions 

4.7 Laboratory Respiratory Protection Level (LRPL) Test Requirement: 

The measured laboratory respiratory protection level (LRPL) for each air-purifying 

escape respirator shall be 2000 or greater, for 95% of trials, sampled in the breathing 

zone of the respirator, and shall be 150, or greater, for 95% of trials, sampled outside the 

breathing zone (under the hood). Each trial must meet the breathing zone criteria and 

‘under the hood’ criteria simultaneously for the trial to be considered passing. Test 

subject and replication numbers are outlined in Table 8. 

10
 
 

Table 8.—Anthropometric test criteria 

Small Medium Large 

Face Length 

and 

Face Width 

Cell A 

*Use LANL boxes 1, 2, 

3, 4 (2 or 3 subjects each 

box, 2 trials per subject) 

Subjects= 10 

Trials= 20 

Cell D 

*Use LANL boxes 3, 4, 5, 6, 7, 

8; panel size 17 (2 or 3 

subjects each box, 2 trials per 

subject) 

Subjects= 17 

Trials= 34 

Cell G 

*Use LANL boxes 7, 8, 9, 10; 

panel size 11 (2 or 3 subjects 

each box, 2 trials per subject) 

Subjects= 11 

Trials= 22 

Head 

Circumference 

Cell B 

N/A 

Subjects= 0 

Trials= 0 

Cell E 

N/A 

Subjects= 0 

Trials= 0 

Cell H 

570-603 mm 

Subjects= 10 

Trials= 20 

Neck 

Circumference 

Cell C 

306-378 mm 

Subjects= 10 

Trials= 20 

Cell F 

355-403 mm 

Subjects= 10 

Trials= 20 

Cell I 

378-451 mm 

Subjects= 10 

Trials= 20 

*Adapted from the Los Alamos National Laboratory report respirator test panel 

The respirator is tested in an atmosphere containing 20-40 mg/m3 corn oil aerosol of a 

mass median aerodynamic diameter of 0.4 to 0.6 micrometers. Should a group of test 

subjects result in LRPL trials where less than 95% of trials have passing results, one 

addition run of test subjects that fills the entire anthropometric panel requirements may 

be performed to increase the total number of trials; the total number of trials will be the 

sum of trials from the first and second run of subjects. All trials shall be considered in the 

Practical Performance criteria of paragraph 4.8. The LRPL shall be calculated using nine 

exercises: Normal Breathing, Deep Breathing, Turn Head Side to Side, Move Head Up 

and Down, Reach for the Floor and Ceiling, On Hands and Knees - Look Side to Side, 

Facial Grimace, Climb Stairs at a Regular Pace, and Normal Breathing. 

For each size category (Small, Medium, and Large), each cell corresponding to the 

anthropometric parameter will be tested. Cells can be either consecutively tested (if the 

test subjects only meet the requirements of a specific cell) or simultaneously tested (if the 

test subjects meet the requirements of more than one cell) for each size category. 

4.8 Practical Performance: 

The Practical Performance of the air-purifying escape respirator shall be evaluated as part 

of the test procedures of paragraphs 3.4, Breathing Gas, and 4.7, Laboratory Respirator 

Protection Level. The Practical Performance of the respirator shall evaluate human 

11
 
interface issues associated with the use of the escape respirator. As a minimum, 

contributing factors (if applicable based upon the respirator design) are: the use of mouth 

bits and nose clips; seal of the hood around the respirator wearer’s neck; seating of inner 

masks; position of the hood on the respirator wearer’s head; and strength required to don 

the respirator. Test subjects shall be trained on proper use of the escape respirator in 

accordance with the applicant’s instructions identified in paragraph 8.0, Training. 

Inability of any test subject participating in the test procedures of paragraphs 3.4, 

Breathing Gas, and 4.8, Laboratory Respirator Protection Level, to complete the test 

procedures shall constitute a failure of the Practical Performance requirement for that 

trial. 

Practical Performance trials shall be accumulated from the test procedures of paragraphs 

3.4, Breathing Gas, and 4.7, Laboratory Respirator Protection Level. For the total of these 

accumulated trials, 95% of these trials shall exhibit acceptable Practical Performance. 

Should 95% of the Practical Performance test trials not be acceptable, one additional run 

of test trials consisting of either, or both, paragraph 3.4, Breathing Gas, or paragraph 4.8, 

Laboratory Respirator Protection Level, may be performed to increase the total number 

of trials. The total number of trials will be the sum of trials from the first and second run 

of subjects. 

4.9 Donning: 

The time to don the respirator from the ready-to-use configuration shall be no greater 

than 30 seconds. The ready to use configuration is the operational packaging state prior 

to use such that immediately upon opening allows the user to don the respirator. 

4.10 Environmental Conditioning Requirements: 

Environmental, vibration, and drop conditioning shall be performed on escape respirators 

in the ready-to-use configuration. The ready-to-use configuration is the operational 

packaging state prior to use, such that immediately upon opening allows the user to don 

the respirator. Respirators will be visually inspected following environmental 

conditioning to ensure no damage or deterioration has occurred that could negatively 

affect the intended use of the respirator. 

Environmental conditioning shall be performed in accordance with Table 9. 

12
 
 

 

 

 

 

 

 

 

 

Table 9.—Environmental Conditioning 

Test Test Method Test Condition Duration 

Hot Constant Mil-Std-810F; 

Method 501.4 710

C (1600F), Constant 5 Weeks 

Cold Constant Mil-Std-810F, 

Method 502.4 

Basic Cold, -320

C (-240F); 

Constant 3 Days 

Humidity Mil-Std-810E, 507.3; 

Realistic, Natural Cycle 

Humidity Profiles in the 

U.S. 

5 Days, “Quick Look” 

Mil-Std-810E 

Table 507.3-II 

Transportation/Vibration Mil-Std-810F, 514.5 

US Roadway Vibration, 

Unrestrained 

12 Hours/Axis, 3 Axis; 

 Total Duration =36 

Hours, equivalent to 

12,000 miles 

Drop Standard Drop Test Height of 3 feet 1 drop on each of the 3 

Axes per Unit. 

4.11 Test Sequence and Quantity: 

Testing of the Escape Respirator shall follow Table 10. 

Table 10.—Test Sequence and Quantity 

Test 

Order 

Resistance 

and 

Breathing 

Gas 

Human 

Factors 

Service 

Life, 

100 Lpm 

Service 

Life Testing, 

64 Lpm 

flow 

Penetration 

and 

Permeation 

Testing 

Efficiency 

Particulate LRPL 

Test† 

Qty

1 

2. 

24*

Inhalation 

Resistance 

Para 3.1 

Exhalation 

Resistance 

Para 3.1 

3-9 

Donning 

Para 4.9 

Fogging 

Para 3.3 

30 

Hot Constant 

Para 4.10 

Cold 

Constant Para 

4.10 

60 

Hot Constant 

Para 4.10 

Cold 

Constant Para 

4.10 

6 *

Hot Constant 

Para 4.10 

Cold 

Constant Para 

4.10 

20 

Hot Constant 

Para 4.10 

Cold 

Constant Para 

4.10 

30-65 

LRPL 

Para 4.7 

Practical 

Performance 

Para 4.8 

3. 

CO2 Machine 

Testing 

84.63(b)(c)(d) 

Para.3.4.1 

Field of 

View 

Para 3.2 

Humidity Para 

4.10 

Humidity Para 

4.10 

Humidity Para 

4.10 

Humidity Para 

4.10 

4. 

5. 

Breathing 

Gas (Human 

Subjects) 

Para 3.4.2 

Practical 

Performance 

Para 4.8 

Flammability 

and Heat 

Resistance 

Para 3.5 

Transportation/ 

Vibration 

Para 4.10 

Drop 

Para 4.10 

Transportation/ 

Vibration 

Para 4.10 

Drop 

Para 4.10 

Transportation/ 

Vibration 

Para 4.10 

Drop 

Para 4.10 

Transportation/ 

Vibration 

Para 4.10 

Drop 

Para 4.10 

6. 

Service Life 

100 Lpm 

Para 4.3 

Service Life 

64 Lpm 

Para 4.2 

System 

Testing 

Para 4.6 

Filter 

Efficiency 

Para 4.4 

13
 
* A total six systems tests are performed, 3 GB and 3 HD. Two systems tests, 1 GB and 1 HD, are performed prior 

to Para. 4.10 Environmental Conditioning. Four systems tests, 2 GB and 2 HD, are performed after Para. 4.10 

Environmental Conditioning. 

† All tests in the Resistance and Breathing Gas and LRPL column are performed prior to Paragraph 4.10, 

Environmental Conditioning 

5.0 Quality Assurance Requirements: 

5.1 Quality Control Plan: 

Respirators submitted for CBRN approval shall be accompanied by a complete quality 

control plan meeting the requirements of Subpart E of 42 CFR, Part 84. 

5.2 Sampling/Test/Inspection Plan: 

The applicant shall specify a sampling/test/inspection plan for respirator parts and 

materials to ensure the construction and performance requirements of this standard are 

established through the manufacturing process. As a minimum, specific attributes to be 

addressed are: 

a) Materials of construction used for respirator parts that form a barrier between 

the user and ambient air. 

b) Integrity of mechanical seals that comprise a barrier between the user and 

ambient air. 

c) Final performance quality control tests on complete air-purifying escape 

respirators demonstrating compliance with the gas life and particulate filter 

requirements of this standard. 

6.0 General Requirements: 

In addition to the requirements of 42 CFR, Subpart G – General Construction and 

Performance Requirements, the following requirements apply: 

Prior to making or filing any application for approval or modification of approval, the 

applicant shall conduct, or cause to be conducted, examinations, inspections, and tests of 

respirator performance, which are equal to or exceed the severity of those prescribed in 

the standard. Chemical Agent Penetration and Permeation Resistance against Distilled 

Sulfur Mustard (HD) and Sarin (GB) tests, Paragraph 4.6, are excluded from this 

requirement. 

7.0 Useful Life and Maintenance: 

The applicant will identify an initial useful life, not to exceed five (5) years, of the escape 

respirator. The “useful life” is defined as the length of time a unit can remain deployed in 

the ‘ready to use’ stowed condition. All applications for certification must specify useful 

service life with supporting data and rationale. Further, a rationale must be included for 

any sampling plan set forth in the user’s manual which would extend the useful life of the 

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escape respirator beyond any initial useful life. However, extensions of useful life will 

be determined during the last year of the initial useful life. 

The following guidelines should be included in the useful service life plans: 

a. Useful life plans should be based upon reliability engineering methodology and 

describe the conditions for use for the unit. Each plan will be individually evaluated. 

b. All respirator service actions are the responsibility of the applicant, or their authorized 

representative. The user/owner of the respirators should perform basic inspections as 

described in the instruction manual and/or as required by federal regulations. 

c. In order for an escape respirator to receive an incremental useful life extension, some 

service action must be performed on each unit. 

d. After the service action has been performed, the applicant, or their authorized 

representative, should collect a random sample of the serviced units and performance test 

these respirators to verify that they function as approved. The purpose of post-service 

sampling and performance testing is to identify unexpected problems caused by 

uncontrolled or unpredicted factors. 

e. The applicant may define “performance testing” by specifying the following: test 

procedures, pass/fail standards, performance tolerances, sample size, etc. 

f. An acceptable useful life plan is exemplified in Table 11. 

Table 11.—Useful life plan timeline 

Start 1st Service Date 2nd Service Date 3rd -- etc. Stop 

[--------I----------- ---------I----------- ---------I----------- ---------I----------- -------I→ 1st Service expiration After a completed After a completed After a completed Terminal End of 

date permanently action on each unit action on each unit action, etc. useful life 

visible on the unit stamp 2nd service stamp 3rd service 

date or terminal date date or terminal date 

Note: The date on which the unit must be removed from service is to be 

permanently marked and clearly visible on the unit at the time of manufacture. If 

an incremental service life is granted, the applicant, or their authorized 

representative, must stamp the unit with a new date, as described by the time line 

model. The terminal date represents the final expiration date of the unit with no 

further extensions. 

8.0 Training: 

The applicant shall identify training requirements associated with their air-purifying 

escape respirator. As a minimum, the applicant shall include an instruction manual, 

which shall address donning procedures, respirator use, maintenance (care and useful 

life), and cautions and limitations. The applicant shall also provide for training aid 

systems, to include a training respirator that mimics the performance of the approved 

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respirator, such as inhalation and exhalation breathing resistance that will develop user 

proficiency in operation of the equipment, as well as identification of periodic refresher 

training requirements to maintain user proficiency. The applicants’ training materials 

shall be used as the basis for preparing the human test subjects in the test procedures of 

paragraph 3.4, Breathing Gas, paragraph 4.7, Laboratory Respirator Protection Level, and 

paragraph 4.9, Donning. 

9.0 Markings and Labels: 

In accordance with the requirements of paragraph 84.33 of 42 CFR, Subpart D, approval 

labels shall be marked with a CBRN Rating as determined by paragraph 4.1 Duration 

Rating, of the Statement of Standard for Chemical, Biological, Radiological and Nuclear 

(CBRN) Air-Purifying Escape Respirator dated September 30, 2003. For example: 

(a) Respirators receiving approval for a 30 minute duration rating are marked: 

ESCAPE ONLY NIOSH CBRN 30. 

(b) Respirators receiving approval for a 30 minute duration rating with carbon monoxide 

protections are marked: 

ESCAPE ONLY NIOSH CBRN 30 with Carbon Monoxide 

(c) Respirators receiving approval for a 30 minute duration rating with a specific category 

are marked: 

ESCAPE ONLY NIOSH CBRN 30 with “chemical” Specific 

(d) Respirators receiving approval for a 30 minute duration, with an specific category, 

and carbon monoxide are marked: 

ESCAPE ONLY NIOSH CBRN 30 with “chemical” Specific and with Carbon Monoxide 

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