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Preparing for an Influenza Pandemic Personal Protective Equipment for Healthcare Workers (2008) / Chapter Skim
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Appendix C: PPE-Related Standards and Regulations
Pages 181-182

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From page 181...
... C PPE-Related Standards and Regulations TABLE C-1 Overview of PPE-Related Standards and Regulations Surgical FDA guidance:a respirators • NIOSH certification -- tested to meet criteria outlined in 42 CFR 84 • Fluid resistance: ASTM F1862:2000a • Material performance: ASTM F2100-04 • Bacterial filtration efficiency: ASTM F2101-01 • Flammability: 16 CFR 1610, UL 2154 OSHA compliance: • NIOSH certification -- tested to meet criteria outlined in 42 CFR 84 • Comprehensive respirator program that includes annual fit testing Other OSHA compliance: respirators • NIOSH certification -- tested to meet criteria outlined in 42 CFR 84 • Comprehensive respirator program that includes annual fit testing Surgical FDA guidance: masks • Particulate filtration: ASTM F1215:1989 • Bacterial filtration: ASTM F2101:2001 • Fluid resistance: ASTM F1862:2000a • Material performance: ASTM F2100-04 • Differential pressure: MilM36945C • Flammability: 16 CFR 1610, UL2154 Continued 181
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From page 182...
... : protection • ANSI standard Z87.1-1989 (for devices purchased after 7/5/94) NOTE: AAMI = Association for the Advancement of Medical Instrumentation; AATCC = American Association of Textile Chemists and Colorists; ANSI = American National Standards Institute; ASTM = ASTM International; FDA = Food and Drug Administration; ISO = International Organization for Standardization; NIOSH = National Institute for Occupational Safety and Health; OSHA = Occupational Safety and Health Administration; PPE = personal protective equipment.
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Key Terms

  • occupational safety
  • standards institute
  • international organization
  • ppe subject
  • requirements include

  • american national
  • personal protective
  • health administration
  • include establishment
  • fda regulations

  • astm international
  • protective equipment
  • establishment registration
  • manufacturing quality
  • medical instrumentation

  • labeling regulations
  • textile chemists
  • devices purchased
  • national institute
  • drug administration

  • ansi standard
  • national standards
  • american association


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