relate to conformity assessment for non-respirator PPT. The chapter also briefly discusses the conformity assessment approach used in the European Union for PPT products. These examples provide the details for the steps in the conformity assessment process described in Chapter 2 and throughout the remainder of the report.

RESPIRATOR CERTIFICATION

The National Institute for Occupational Safety and Health (NIOSH) is the principal governmental agency with responsibility for testing and certifying respirators. Certification testing and related research is conducted at NIOSH’s National Personal Protective Technology Laboratory (NPPTL) in Pittsburgh, Pennsylvania. NIOSH’s work in post-marketing testing and evaluation efforts, including product and manufacturing audits, is also conducted by NPPTL. Testing and certification requirements are detailed in federal regulations (42 CFR Part 84).

The U.S. federal government has been involved in evaluating respiratory protection since the early 1900s. With the Organic Act of 1910 (Public Law 61-179), the U.S. Bureau of Mines (USBM) was founded to deal with a wave of catastrophic mine disasters. Early goals of the USBM were aimed at determining whether fatalities from coal mine explosions were caused by injury or suffocation. The mission of USBM expanded over the years to testing and certifying respirators. The USBM was solely responsible for testing and certifying respirators until NIOSH was established in 1971 with a broader health and safety focus on all occupations. In 2001, NIOSH received a congressional mandate to expand occupational safety and health research. As part of this direction, NIOSH established NPPTL as a new laboratory focused on PPT and responsible for respirator certification.

Standards

Standards for respirator testing and certification are set in federal regulations as part of the Code of Federal Regulations (CFR). In 1972, NIOSH and USBM jointly published updated respirator certification regulations as 30 CFR Part 11. NIOSH undertook primary responsibility for performance testing of respirators in 1973. Respirator responsibilities for USBM, and subsequently the Mine Safety and Health Administration



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