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P100 filters, under 42 CFR part 84, are the only filters permitted to be magenta in color. [25] HE (high-efficiency) labeled filters (described in the subsection) are only provided for powered air-purifying respirators. HE-marked filters are 99.97% efficient against 0.3 micron particles and are oil-proof. [26] [27] [28]
A surgical N95 is also rated against fluids, and is regulated by the US Food and Drug Administration under 21 CFR 878.4040, in addition to NIOSH 42 CFR 84. 42 CFR 84, the federal standard which the N95 is part of, was created to address shortcomings in the prior United States Bureau of Mines respirator testing standards, as well as tuberculosis ...
42 CFR 84 replaces the 30 CFR 11 respirator regulation used by NIOSH. As of 2001, quality assurance of SCBA harnesses is required. As of 2001, quality assurance of SCBA harnesses is required. Labels have been updated to remove MSHA emblems from respirator labels, as MSHA is no longer involved in respirator approval except for respirators ...
For respirators, MSHA and NIOSH define HEPA as filters blocking ≥ 99.97% of 0.3 micron DOP particles, under 30 CFR 11 and 42 CFR 84. Since the transition to 42 CFR 84 in 1995, use of the term HEPA has been deprecated except for powered air-purifying respirators. [25] However, by definition, ANSI Z88.2-2015 considers N100, R100, P100, and HE ...
The Medical Devices Directive (MDD 93/42/EEC) similarly lists several requirements regarding the design of a medical device. The Medical Devices Regulation (MDR (EU) 2017/745), replacing the MDD from 2021, requires information to allow the design stages applied to the device to be understood as part of the design and manufacturing information ...
Ricin is classified as an extremely hazardous substance in the United States as defined in Section 302 of the US Emergency Planning and Community Right-to-Know Act (42 U.S.C. 11002), and is subject to strict reporting requirements by facilities that produce, store, or use it in significant quantities.
Title 10 Code of Federal Regulation (CFR) Part 50.5, Deliberate Misconduct of the U.S. Nuclear Regulatory Commission (NRC) regulations, addresses the prohibition of certain activities by individual involved in NRC-licensed activities. 10 CFR 50.5 is designed to ensure the safety and integrity of nuclear operations.