42 C.F.R. § 84.305

Current through November 30, 2024
Section 84.305 - Performance test requirements
(a) NIOSH will conduct the performance test on a total of six of the units submitted for approval, as follows:
(1) Three units will be tested on a breathing and metabolic simulator in the condition in which they were received from the applicant; and
(2) Two units will be tested on a breathing and metabolic simulator after being subjected to the environmental treatments specified in § 84.307 ; and
(3) One unit will be tested, in the condition in which it was received from the applicant, by a human subject on a treadmill.
(b) Except as provided under paragraph (c) of this section, the performance test will apply a repeating cycle of work rates, according to the sequence and requirements specified in Table 3, until the oxygen supply of the unit is exhausted.
(c) Testing of CCERs with less than 50 liters of capacity, as determined by the capacity testing under § 84.304 , will require the submission of additional test units to fully apply the work-rate test sequence and requirements specified in Table 3. The testing of each individual unit will complete the cycle specified in Table 3 until the breathing supply of the initial test unit is exhausted. This initial test unit will then be replaced by a second unit, which will continue the test cycle, beginning at the work rate in the cycle at which the initial unit was exhausted, and completing the full period specified in Table 3 for that work rate before proceeding to the subsequent work rate, if any, specified in Table 3. Each initial testing unit will be replaced as many times as necessary to complete the cycle, not to exceed two replacement units per initial test unit.
(d) The performance test will begin with two exhalations into the unit at the specified ventilation rate and then follow the manufacturer's instructions to determine the design's susceptibility to hypoxia upon initial donning.

Table 3-Performance Test Requirements

Work-rate
test sequence
Duration per cycle (in minutes)VO2 (L/min)VCO2 (L/min)Ve (L/min)RF (breaths/min)
1. Peak53.003.2065.025
2. High152.001.8044.020
3. Low100.500.4020.012

VO2 = volume of oxygen consumed per minute; VCO2 = volume of carbon dioxide produced per minute.

Ve = ventilation rate in liters of air per minute; RF = respiratory frequency.

42 C.F.R. §84.305