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-0611 Revision: 0.0 Date: 7 April 2014

EVALUATION OF DONNING OF CLOSED CIRCUIT ESCAPE RESPIRATORS (CCER)

1. PURPOSE

This procedure establishes the test for ensuring that the level of protection provided by donning a

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 84.306 (b) (1), and (2) 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 the Donning test for closed circuit escape respirators in sufficient detail such 

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

necessary resolution, conduct the test, and determine whether or not the product passes the test.

3. EQUIPMENT AND MATERIALS

Timer, Digital stopwatch, calibrated to hundredths of a minute (Cronus Precision Products, Inc.)

or equivalent.

4. TEST REQUIREMENTS AND CONDITIONS

4.1. Test subjects must meet requirements of the NIOSH Institutional Review Board approved 

Protocol. Refer to HSRB-12-NPPTL-04, “PROTOCOL FOR TESTS WITH HUMAN 

SUBJECTS OF CLOSED-CIRCUIT ESCAPE RESPIRATORS IN CERTIFICATION, 

QUALITY ASSURANCE AND DEVELOPMENT” for the proper consent form and 

complete details on the use of human test subjects in respirator certification testing.

4.2. Prior to beginning any testing, all measuring equipment 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.
Procedure No. TEB-CCER-STP-0611 Revision: 0.0 Date: 7 April 2014 Page 2 of 6

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. Procedures will be conducted at the following ambient conditions:

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

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

4.6. The donning test will be conducted on a total of three units submitted for approval, each 

with a different human subject.

4.6.1. Three human subjects, two males and one female, one subject per unit, will 

conduct the test.

4.6.2. The three subjects will range in height and weight as follows: one subject of 

height ≥ 174 cm and weight ≥ 90 kg; one subject of either 163 cm ≤ height < 174 

cm, regardless of weight, or 72 kg ≤ weight < 90 kg, regardless of height; and 

one subject of height < 163 cm and weight < 72 kg.

4.7. Prior to performing the CCER donning, each subject will receive training in how to don, 

operate and doff the CCER.

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

instructions, as contained in one or more of the following required topics: 

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

4.7.1.2. Procedures for inspecting the operating condition of the CCER (§84.302 

(h) (1) (iv))

4.7.1.3. 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))

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

5. PROCEDURES

5.1. Prior to performing the CCER donning evaluation test, the CCER will be put in the “as 

ready” condition specified by the manufacturer.

5.2. The CCER in the “as ready” condition will be placed on a table or bench.

5.3. All test subjects will receive the consent form and procedures included in HSRB 12-

NPPTL-04 for wearability test.

5.4. The subject will stand in front of the table or bench within an arm’s length of the CCER.
Procedure No. TEB-CCER-STP-0611 Revision: 0.0 Date: 7 April 2014 Page 3 of 6

5.5. The tester will indicate to the subject to begin donning the CCER and simultaneously

begin timing.

5.5.1. A countdown may be used.

5.6. The tester will stop timing when the subject has completed donning which includes:

5.6.1. Isolating his/her lungs:

5.6.1.1. In the case of mouth-bit devices, isolation includes inserting the mouthbit into the mouth, and applying the nose clip to the nose.

5.6.1.2. In the case of facepiece devices, isolation includes achieving a face seal.

5.6.2. Activating the oxygen supply system.

5.6.3. The donning time does not include any additional steps that might be required 

after the lungs are protected to adjust the unit for wear.

6. PASS/FAIL CRITERIA

6.1. The device passes if the donning time recorded in the procedure is 30 seconds or less.

6.2. The device fails if the donning time recorded in the procedure exceeds 30 seconds.
Procedure No. TEB-CCER-STP-0611 Revision: 0.0 Date: 7 April 2014 Page 4 of 6

7. RECORDS AND TEST SHEETS

CCER: Manufacturer: Model: Sample or serial number:

Test subject: Sex: Height: Weight:

Training: Date: Training type:

Test: Date: Donning time:

Comments/notes:

Technician:
Procedure No. TEB-CCER-STP-0611 Revision: 0.0 Date: 7 April 2014 Page 5 of 6

8. ATTACHMENTS

None
Procedure No. TEB-CCER-STP-0611 Revision: 0.0 Date: 7 April 2014 Page 6 of 6

Revision History

Revision Date Reason for Revision

00 15 September 

2011

Initial Review

1.0 8 March 2012 Administrative changes – Document number changed

2.0 3 April 2012 Administrative changes were made to include information from the 

release of the proposed rule

Former document number - STP-00001-PSDB-0012

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.