September 30, 2003 

Attachment B 

Statement of Standard 

For 

Chemical, Biological, Radiological, and Nuclear (CBRN) 

Self-Contained Escape Respirator 

1.0 Purpose: 

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

effectiveness of self-contained escape respirators that address CBRN materials identified 

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

population. The 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 

2.2 42 CFR, Part 84, Subpart H: 

Approval under Title 42, CFR, Part 84, Subpart H, for escape only, with a minimum 

service time of 15 minutes. 

3.0 Requirements Based on Existing National and International Standards: 

3.1 Field of View: 

The CBRN self-contained escape respirator shall obtain a Visual Field Score (VFS) of 70 

or greater when tested in accordance with NIOSH Standard Test Procedure CET-APRS- 
STP-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. 

3.2 Fogging: 

The CBRN self-contained 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+20F 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 self-contained 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+2oF. 

3.3 Breathing Gas: 

Breathing gas criteria will be evaluated as a two-part requirement: 1) a dead-space CO2 

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 4.4. 

3.3.1 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 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 

3.3.2 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 

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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 ten minutes. Carbon dioxide and oxygen data will be 

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

the last five 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 4.4. 

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3.4 Flammability and Heat Resistance: 

Self-contained escape respirators submitted for approval 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. 

3.5 Design Considerations:

 3.5.1 Function: 

The self-contained escape respirator shall provide a barrier from ambient conditions for 

the wearer’s entire head, eyes, and respiratory system. The self-contained escape 

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

proper function of the respirator when fully donned. 

3.5.2 Hood Type Devices: 

The self-contained 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. 

3.5.3 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 self-contained escape respirator. 

4.0 Special CBRN Requirements: 

4.1 Duration/Service Life: 

The self-contained escape respirator shall have a minimum service life of 15 minutes. 

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4.2 Chemical Agent Permeation and Penetration Resistance Against Distilled Sulfur 

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

The self-contained 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. For closed circuit devices, 

they will be connected to a metabolic breathing simulator, using the following protocol: 

For a mean VO2 = 1.67 L/min for 30 minutes (aggregate VO2 = 50 L/minTime) 

VO2 VCO2 Minute Ventilation Resp.rate 

Min L/min, STPD L/min, STPD L/min, STPD b/min 

0-5 3.0 3.2 65 25

 6-20 2.0 1.8 44 20 

21-30 0.5 0.4 20 12 

For open circuit devices, a breathing machine will be used, operating at an air flow rate of 

19.5 Lpm,18 respirations per minute, 1.1 Liters tidal volume. 

Test requirements for Distilled Sulfur Mustard (HD) are shown in Table 3. 

Table 3.—Vapor-Liquid Sequential Challenge of Self-contained Escape Respirator 

with Distilled Sulfur Mustard (HD) 

Agent Challenge Duration of Breathing Maximum Maximum Number Minimum 

Concentration Challenge Machine Peak Breakthrough of Service Life 

(min) Airflow 

Rate 

Excursion 

(mg/m3

) 

(concentration 

integrated 

Systems 

Tested 

(hours) 

(Lpm) over minimum 

service life) 

(mg-min/m3

) 

HDVapor 300 mg/m3* Stated 

Duration*,** 

HDLiquid 0.50 ml† Stated 

Duration** 19.5 0.60‡

 6.0§,‡‡ 3 Stated 

Duration†† 

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

has been sealed. 

†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 equal to applicant’s identified duration 

†† Minimum Service Life is equal to twice the applicant’s identified duration. 

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

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Test requirements for Sarin (GB) agent are shown in Table 4. 

Table 4.—Vapor Challenge of Self-contained Escape Respirator with Sarin (GB) 

Challenge Vapor 

Concentration Concentration 

(mg/m3

) 

Total CT of GB 10,000mg-m3 $ 

Vapor 

Challenge 

Time 

(minutes) 

Breathing 

Machine 

Airflow 

Rate 

(Lpm) 

Maximum 

Peak 

Excursion 

mg/m3 

Stated 

Duration*, 19.5 0.087‡ 

** 

Maximum 

Breakthrough 

(concentration 

integrated 

over minimum 

service life) 

(mg-min/m3) 

0.9 for 

durations less 

than 30 

minutes 

2.1 for 

durations 

greater than 30 

minutes§,‡‡ 

Number 

of 

Systems 

Tested 

Minimum 

Service 

Life 

(hours) 

Stated 

3 Duration†, 

†† 

* 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. 

** Duration of challenge is equal to applicant’s identified duration 

†† Minimum Service Life is equal to the applicant’s identified duration. 

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

$ Exposure will include at least two minutes at a concentration of 2000 mg-m3 

4.3 Laboratory Respiratory Protection Level (LRPL) Test Requirement: 

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

escape respirator shall be 3000 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 5. 

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Table 5.—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 

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 requirement criteria of paragraph 4.4. 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 (if the test 

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

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

4.4 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 

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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 3.3, 

Breathing Gas, and 4.3, 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 

3.3, Breathing Gas, and 4.3, 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 3.3, Breathing Gas, or 

paragraph 4.3, 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. 

4.5 Donning: 

The time to don the self-contained escape 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. 

4.6 Environmental Conditioning Requirements: 

Environmental, vibration, and drop conditioning shall be performed on the self-contained 

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 6. 

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Table 6.—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. 

4.7 Test Sequence and Quantity: 

Testing of the self-contained escape respirator shall follow Table 7. 

Table 7.—Test Sequence and Quantity 

Test 

Order 

Breathing 

Gas† 

Human 

Factors 

Penetration 

and 

Permeation 

Testing 

LRPL 

Test † 

Qty 24. 5-11 6 systems * 30-65 

1. 

Breathing 

Gas 

Para 3.3 

Donning 

Para 4.5 

Hot 

Constant 

Para 4.6 

LRPL 

Para 4.3 

2 

Practical 

Performance 

Para 4.4 

Fogging 

Para 3.2 

Cold Constant 

Para 4.6 

Practical Performance 

Para 4.4 

3 

Field of 

View 

Para 3.1 

Humidity 

Para 4.6 

4 

Flammability 

and Heat 

Resistance 

Para 3.4 

Transportation/ 

Vibration 

Para 4.6 

5 Drop 

Para 4.6 

6 

System 

Testing 

Para 4.2 

* 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. 4.6 Environmental Conditioning. Four systems tests, 2 GB and 2 HD, are performed after Para. 4.6 

Environmental Conditioning. 

† Breathing Gas and LRPL are performed prior to Paragraph 4.6, Environmental Conditioning 

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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 Title 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. 

. 

6.0 General Requirements: 

In addition to the requirements of Title 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 4.2, 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 

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. 

10
 
 

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 8. 

Table 8.—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. service 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 

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 3.3, Breathing Gas, paragraph 4.3, Laboratory Respirator Protection Level, and 

paragraph 4.5, Donning. 

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9.0 Markings and Labels: 

NIOSH will authorize the use of an additional approval label on the self-contained escape 

respirator that demonstrates compliance to the CBRN criteria. This label is to be placed 

in a visible location. The addition of this label will provide visible and easy identification 

of equipment for its appropriate use. 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/Service Life Rating. For example, respirators 

tested for 15 minutes are marked ESCAPE ONLY NIOSH CBRN 15. 

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