42 CFR 84.306
§ 84.306 Wearability test requirements.
United States · 42 CFR — Public Health · Status: effective
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- Citation
- 42 CFR 84.306, § 84.306 Wearability test requirements, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/201828
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Full text
(a) NIOSH will conduct the wearability test on a total of three of the units submitted for approval. Three human subjects (two males and one female), one subject per unit, will conduct the test. 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. All units tested must meet all conditions specified in this section to receive approval.
(b) NIOSH will evaluate the ease and speed with which users can don the CCER, as follows:
(1) Each test subject will be provided with manufacturer instructions, and must be able to don the CCER correctly, isolating the lungs within 30 seconds; 1 and
1 This time limit does not apply to any additional steps that might be required after the lungs are protected to adjust the unit for wear.
(2) A CCER must not include any design, construction, or material characteristic that can be anticipated or demonstrated, under plausible conditions, to hinder the user in the correct and timely donning of the CCER.
(c) NIOSH will continuously monitor CCER use by each test subject during the activities specified in Table 4 to evaluate the ability of the CCER to provide an adequate and uninterrupted breathing supply, including but not limited to the requirements of § 84.303(b), without harming or hindering a user. NIOSH will not approve a CCER if the use of any unit during these activities indicates any potential for the CCER to harm or hinder the user or to fail to provide an adequate and uninterrupted breathing supply to the user during reasonably anticipated conditions and activities of an escape.
Table 4—Wearability Test Requirements
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.