Approvals: 1st Level 2nd Level 3rd Level 

National Institute for Occupational Safety and Health 

National Personal Protective Technology Laboratory 

P.O. Box 18070 

Pittsburgh, PA 15236 

Procedure No. CET-APRS-STP-CBRN-0499 Revision: 1.1 Date: 23 December 2005

STANDARD TEST PROCEDURE (STP) FOR DETERMINING THE DONNING TIME OF 

THE CHEMICAL, BIOLOGICAL, RADIOLOGICAL AND NUCLEAR (CBRN) ESCAPE 

RESPIRATOR (AIR-PURIFYING AND SELF-CONTAINED) 

1. PURPOSE

1.1. This test establishes the procedures for determining the time to don a chemical, 

biological, radiological, and nuclear (CBRN) escape respirator (ER) for approval, 

extension of approval, or examined during certified product audits, meets the 

minimum certification standards set forth in this standard test procedure (STP) as 

prescribed by 42 CFR, Part 84, Subpart G, Section 84.63(a)(c)(d) and Federal 

Register, Volume 60, Number 110, June 8, 1995. 

1.2. The purpose of this test is to qualify the donning effectiveness of a CBRN ER by 

measuring the time at which a respirator can be properly donned in accordance 

with the manufacturer’s user’s instructions. This STP outlines the test procedures 

to test the donning effectiveness for both types of CBRN ER: air-purifying and 

self-contained. It is important that a CBRN ER possess the intrinsic feature to be 

quickly and properly donned from the ready-to-use configuration by the general 

working population. 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. The CBRN ER will be worn by the general population to provide 

protection against CBRN materials resulting from a possible terrorist attack. This 

test method objectively measures the donning effectiveness to ensure that a 

CBRN ER can be properly donned within the required time by the general 

population after reading the respirator manufacturer’s user’s instructions. 

2. GENERAL

This STP describes the determination of donning effectiveness of the CBRN ER (airpurifying and self-contained) test in sufficient detail that a person knowledgeable in the 

appropriate technical field can conduct the test and determine whether or not the product 

meets the test requirements.

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 
Procedure No. CET-APRS-STP-CBRN-0499 Revision: 1.1 Date: 23 December 2005 Page 2 of 11 

3. EQUIPMENT AND MATERIALS

3.1. Test Equipment

3.1.1. Fisher Scientific, Model # 06-662-3 Stop Watch or Equivalent. Figure 1 

illustrates a Fisher Scientific, model # 06-662-3 stop watch. Equivalent 

brands can be used that are traceable to the National Institute of Standards 

and Technology (NIST) calibration. 

Figure 1. Fisher Scientific, model # 06-662-3 stop watch 

3.2. Human Subjects

3.2.1. Eight (8) volunteers will be used to complete the donning effectiveness test 

of the CBRN ER. The volunteers shall be used immediately before 

conducting the following tests: 

• Two (2) volunteers before the Determination of Lens Fogging on 

Chemical, Biological, Radiological, and Nuclear (CBRN) Air-Purifying 

Escape Respirators Test. 

• Six (6) volunteers before the 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) Test. 

NOTE: The recruitment of the eight (8) volunteers does not necessarily 

have to exclusively come from the participants of the fogging and LRPL 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 
Procedure No. CET-APRS-STP-CBRN-0499 Revision: 1.1 Date: 23 December 2005 Page 3 of 11 

tests. If the situation merits a change, volunteers may be recruited from 

other human factor tests being conducted, and the number of volunteers 

from either the fogging test or the LRPL test may be altered. The important 

thing is that the test 

obtained from each volunteer occurs upon completion of the Volunteer 

Agreement Affidavit and Volunteer Agreement Affidavit Explanation 

outlined in the human use protocol for that particular human factor test. 

3.2.2. Each human subject shall be assigned a subject number to be used during 

the actual donning effectiveness test in the following sequence: DTS1, 

DTS2, DTS3...etc. meaning donning test subject #1, donning test subject 

#2, donning test subject #3. 

3.2.3. Test administrator(s): Shall have successfully completed the Centers for 

Disease Control and Prevention (CDC)/ Agency for Toxic Substances and 

Disease Registry (ATSDR) Scientific Ethics Training, the Department of 

Health and Human Services (DHHS)/National Institutes of Health (NIH)

Human Participant Protections Education for Research Teams or an 

equivalent course. Note: The NIOSH Human Subject Review Board will 

deem if courses are equivalent. 

3.3. Required CBRN ER Test Items

3.3.1. If a CBRN ER is available in sizes of small, medium, and large, the 

manufacturer shall supply a minimum of three (3) small, four (4) medium, 

and three (3) large escape respirators. 

3.3.2. If a CBRN ER is available in two sizes, there shall be five (5) of each size 

available for the testing. 

3.3.3. There shall be ten (10) CBRN ER of each one-size mask system. 

4. TESTING REQUIREMENTS AND CONDITIONS

4.1. Before testing, all test equipment shall have been calibrated in accordance with 

the manufacturer's calibration procedure and schedule. At a minimum, all 

measuring equipment utilized for this testing must have been calibrated within the 

preceding 12 months using a method traceable to the NIST. 

4.2. Normal laboratory safety practices must be observed. This includes safety 

precautions described in the current Centers for Disease Control and Prevention 

(CDC) General Laboratory Health and Safety Manual or site-specific procedures 

that are applicable to the health and safety requirements. 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 
Procedure No. CET-APRS-STP-CBRN-0499 Revision: 1.1 Date: 23 December 2005 Page 4 of 11 

4.3. Work benches must be maintained free of clutter and non-essential test 

equipment. 

5. PROCEDURE

NOTE: Reference Section 3. for test equipment, model numbers and manufacturers. For 

calibration purposes, use those described in the manufacturer's operation and 

maintenance manuals. 

5.1. This procedure describes the donning effectiveness test for ensuring that the level 

of protection provided by the donning effectiveness of a CBRN ER meets or 

exceeds the requirements outlined in the Statement of Standard For Chemical, 

Biological, Radiological, and Nuclear (CBRN) Air-Purifying Escape Respirator, 

30 September, 2003 and the Statement of Standard For Chemical, Biological, 

Radiological, and Nuclear (CBRN) Self-Contained Escape Respirator, 30 

September, 2003. Other types of CBRN respiratory protective devices (RPD) may 

be tested for donning effectiveness using this procedure: refer to the primary 

statement of standard for the CBRN RPD being tested for the donning 

requirements. This procedure describes the required sample size, test equipment, 

test procedure, data collection methods and the pass or fail criteria for the type of 

CBRN ER being tested. 

5.2. Test Items

5.2.1. Test Items 

Indicate on the attached test data sheet 1 of 2 the following general pretest 

incoming inspection information about the CBRN ER: 

- NIOSH application number: 

- Type of ER being tested (APR, self-contained or other): 

- Name of manufacturer: 

- Model number of RPD: 

- Model number of canister (if applicable): 

- Date arrived: 

- Test Date: 

- General condition of packaging: 

- Appearance of RPD and canisters (if applicable): 

- Any specific physical anomalies: 

- Type of test being conducted: 

- Type of test it is being conducted before (fogging, LRPL or other): 

5.2.2. Number Test Items 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 
Procedure No. CET-APRS-STP-CBRN-0499 Revision: 1.1 Date: 23 December 2005 Page 5 of 11 

Prior to performing the donning effectiveness test, all test item packages 

shall be individually numbered with an indelible pen in two (2) places in a 

sequence that the number can be traced to the NIOSH application number, 

manufacturer, and model. For example, the number sequence can be S1, 

M1, and L1. The S1 will mean a small CBRN ER #1, M1 will mean a 

medium CBRN ER #1 and L1 will mean a large CBRN ER #1. After the 

donning effectiveness test has been completed, the ER shall be marked in 

two (2) places on the exterior hood (non-lens and non-component region) 

with the same number that was originally marked on the respective 

packaging. 

5.3. Familiarization of Respirator Manufacturer’s User’s Instructions 

Prior to testing, each human subject shall be provided with training that is in 

accordance with the training requirements that are specified in the manufacturer’s 

application for certification. The applicant’s training materials shall be used as the 

basis for preparing the test subjects. The respirator training requirements as a 

minimum shall include a user’s instruction manual that shall address sizing, 

donning procedures, system use, maintenance (care and useful life), and cautions 

and limitations. If the respirator user’s instruction manuals are not available or 

accessible and the instructions are printed on the respirator packaging, then the 

human subjects shall be provided with the unopened packaged respirator so the 

subjects can read the user’s instructions directly from the packaging. 

5.4. Assigning Respirator Sizes and Human Subject Number

The test administrator shall provide the proper size respirators to the human 

subjects in accordance with the respirator manufacturer’s user’s instruction 

manual. Also, the test administrator shall assign a human subject number in 

accordance with Section 3.2.2. of this STP. 

5.5. Performing the Donning Effectiveness Test 

After the human subjects have been properly trained on wearing the respirator and 

have been provided with a proper size respirator in accordance with the respirator 

manufacturer’s user’s instruction manual, the test administrator shall perform the 

donning effectiveness test individually with the human subjects by using the 

following procedures: 

5.5.1. The test administrator shall document on the attached test data sheet 2 of 2 

the following general pretest information [GPI] and specific human 

subject information before conducting any tests: 

- NIOSH application number [GPI]: 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 
Procedure No. CET-APRS-STP-CBRN-0499 Revision: 1.1 Date: 23 December 2005 Page 6 of 11 

- Manufacturer of the CBRN ER [GPI]: 

- CBRN ER type (APR, self-contained, PAPR, etc.) [GPI] 

- Human subject number [specific human subject] 

- Respirator number and respirator size [specific human subject] 

- Test date [specific human subject] 

- Test time [specific human subject] 

5.5.2. The test administrator shall test the functioning of the stop watch by 

initializing the time reading to zero (0:00), depressing the start button, 

allowing it to time for 30 seconds and depressing the stop button. If the 

stop watch is functioning properly, initialize the reading on the stop watch 

to (0:00) in order to be ready to obtain the donning time of the first human 

subject. 

5.5.3. The test administrator shall instruct the human subject to remove the 

respirator from the ready-to-use configuration packaging and properly don 

the respirator in accordance with the manufacturer’s user’s instructions 

upon hearing the word, “Begin”. The test administrator shall also instruct 

the human subject to hold their hands up while saying the word, “Done” 

after properly donning the respirator. The human subject shall be informed 

that they have 30 seconds to properly don the respirator. 

5.5.4. The donning effectiveness test shall be performed with one human subject 

at a time out of view and undisturbed from other human subjects. 

5.5.5. The human subject shall hold their assigned respirator in their hands by 

their waist and wait for the test to begin. 

5.5.6. The test administrator shall begin the test by saying the word, “Begin” to 

the human subject and simultaneously starting the stop watch by 

depressing the start button. At this point, the human subject shall begin 

removing the respirator from the ready-to-use configuration packaging 

with the intent to don the respirator. 

5.5.7. Once the human subject properly dons the respirator and holds their hands 

up while saying the word “Done”, the test administrator shall depress the 

stop button on the stop watch. 

5.5.8. The time to properly don the respirator shall be recorded on data sheet 2 of 

2 in the donning time (DT) column for that particular test subject. 

5.5.9. After the human subject removes the respirator, the test administrator shall 

label the respirator in two (2) places on the exterior hood (non-lens and 

non-component region) with the same number that was originally marked 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 
Procedure No. CET-APRS-STP-CBRN-0499 Revision: 1.1 Date: 23 December 2005 Page 7 of 11 

on the respective ready-to-use configuration packaging. 

5.5.10. Repeat the steps indicated in Sections 5.5.1. through 5.5.9. of this STP to 

obtain the donning test times for the remaining human subjects. 

5.6. Data Analysis

The test administrator shall count the following on test data sheet 2 of 2: 

1.) Total number of human subjects whose donning time is less than or equal to 

30 seconds; and 

2.) Total number of human subjects whose donning time is greater than 30 

seconds. 

6. PASS OR FAIL CRITERIA 

6.1 The criterion for passing this test is set forth in 42 CFR, Part 84, Subpart G, 

Section 84.63(a)(c)(d). 

6.2 This test establishes the standard procedure for ensuring that: 

84.63 Test requirements; general. 

(a) Each respirator and respirator component shall when tested by the applicant 

and by the Institute, meet the applicable requirements set forth in subparts H 

through L of this part. 

(c) In addition to the minimum requirements set forth in subparts H through L of 

this part, the Institute 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 

atmospheres. 

(d) 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. 

6.3 A candidate CBRN ER must comply with either the Statement of Standard for 

Chemical, Biological, Radiological and Nuclear (CBRN) Air-Purifying Escape 

Respirator, 30 September, 2003 or the Statement of Standard for Chemical, 

Biological, Radiological and Nuclear (CBRN) Self-Contained Escape Respirator, 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 
Procedure No. CET-APRS-STP-CBRN-0499 Revision: 1.1 Date: 23 December 2005 Page 8 of 11 

30 September, 2003. Both standards state, “The time to don the respirator from 

the ready-to-use configuration shall be no greater than 30 seconds. The ready-touse configuration is the operational packaging state prior to use such that 

immediately upon opening allows the user to don the respirator”. 

6.3.1 For the applicant’s respirator to successfully pass the donning 

effectiveness requirement, the total number of subjects whose donning 

time is less than or equal to 30 seconds shall be greater than or equal to six 

(6). 

6.4 Other types of CBRN RPD may be tested for donning effectiveness using this 

procedure: refer to the primary statement of standard for that particular CBRN 

RPD being tested for the donning performance requirements. 

7. RECORDS AND TEST DATA SHEETS

7.1. All test data shall be recorded on the attached Determination of Donning 

Effectiveness Test of The CBRN Escape Respirator (Air-Purifying and SelfContained) Test Data Sheets. 

7.2. All videotapes and photographs of the actual test being performed, or 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 shall be handled as follows: 

7.3.1. If the failure occurs on a new certification application, or extension of 

approval application, send a test report to the Respirator Branch; 

Certification, Evaluation and Testing (CET) Team Leader 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 the test administrator and the CET 

Team Leader 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 Respirator Branch Chief, or designee, 

following the standard operating procedures outlined in the Procedure for 

Scheduling, and Processing Post-Certification Product Audits, RB-SOP0005-00. 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 
Procedure No. CET-APRS-STP-CBRN-0499 Revision: 1.1 Date: 23 December 2005 Page 9 of 11 

Appendix A 

General Pretest Incoming Inspection Information 

(Test Data Sheet 1 of 2) 

NIOSH application 

number:_________________________________________________________ 

Type of ER being tested (APR, self contained or other):__________________ 

Name of manufacturer: 

_____________________________________________________________ 

Model number of RPD:_______________________________________________________ 

Model number of canister (if 

applicable):_______________________________________________ 

Date 

arrived:_____________________________________________________________________ 

Test 

Date:______________________________________________________________________ 

General condition of 

packaging:______________________________________________________ 

Appearance of RPD and canisters:_______________________________________________ 

Any specific physical 

anomalies:_____________________________________________________ 

Type of test being 

conducted:________________________________________________________ 

Type of test that is being conducted before donning effectiveness: fogging, LRPL or other 

human factor 

tests:_______________________________________________________________________ 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 
Procedure No. CET-APRS-STP-CBRN-0499 Revision: 1.1 Date: 23 December 2005 Page 10 of 11 

Donning Effectiveness Test Of The CBRN Escape Respirator- 

(Air-Purifying and Self-Contained) Data Sheet 

(Test Data Sheet 2 of 2) 

NIOSH application number: ________________________________________________ 

Manufacturer of the CBRN ER:______________________________________________ 

CBRN ER Type (APR, self-contained, PAPR, etc.):______________________________ 

Requirement: For the applicant’s CBRN ER to successfully pass the donning effectiveness requirement, 

the total number of subjects whose donning time is less than or equal to 30 seconds shall 

be greater than or equal to six (6). 

Pass _______ Fail ________ 

Results: 

Test # Human 

Subject Number 

and Gender (F/M) 

Donning Time Respirator Number 

and Size 

Test Date Time of Test 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

NOTE: A minimum of 8 tests shall be performed, but above chart allows 12 data points to be entered

Total number of subjects whose donning time is less than or equal to 30 Seconds: ______ 

Total number of subjects whose donning time is greater than 30 Seconds: ____________ 

Comments: 

 

 

Test administrator signature: _______________________________ Date: ___________ 

Laboratory supervisor signature: _____________________________Date: ___________ 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 
Procedure No. CET-APRS-STP-CBRN-0499 Revision: 1.1 Date: 23 December 2005 Page 11 of 11 

Revision History 

Revision Date Reason for Revision 

0 17 September 2004 Historic document 

1.1 23 December 2005 Update header and format 

No changes to method 

 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy 

Uncontrolled Copy 

 Uncontrolled Copy