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C PPE-Related Standards and Regulations TABLE C-1 Overview of PPE-Related Standards and Regulations Surgical FDA guidance:a respirators â¢ NIOSH certificationâtested to meet criteria outlined in 42 CFR 84 â¢ Fluid resistance: ASTM F1862:2000a â¢ Material performance: ASTM F2100-04 â¢ Bacterial filtration efficiency: ASTM F2101-01 â¢ Flammability: 16 CFR 1610, UL 2154 OSHA compliance: â¢ NIOSH certificationâtested to meet criteria outlined in 42 CFR 84 â¢ Comprehensive respirator program that includes annual fit testing Other OSHA compliance: respirators â¢ NIOSH certificationâtested to meet criteria outlined in 42 CFR 84 â¢ Comprehensive respirator program that includes annual fit testing Surgical FDA guidance: masks â¢ Particulate filtration: ASTM F1215:1989 â¢ Bacterial filtration: ASTM F2101:2001 â¢ Fluid resistance: ASTM F1862:2000a â¢ Material performance: ASTM F2100-04 â¢ Differential pressure: MilM36945C â¢ Flammability: 16 CFR 1610, UL2154 Continued 181
182 PREPARING FOR AN INFLUENZA PANDEMIC Surgical FDA guidance: gowns â¢ Barrier performance: ANSI-AAMI PB70:2003 o 4 levels of performance based on AATCC 42:2000 and ASTM F1671:2003 o Fluid resistance: ASTM F1670-03 o Bloodborne pathogens resistance: ASTM F1671-03 â¢ Non-barrier properties o Snag resistance: ASTM D5587:1996 and ASTM D2582:2000 o Grab tensile strength: ASTM D5034:1995 o Linting: IST 160.1:1995 o Heat loss: ASTM F1868:1998, Part C o Water vapor transmission: ASTM E96:2000 â¢ Flammability: 16 CFR 10, UL 2154 â¢ Sterilization method and validation â¢ Biocompatibility testing: ISO 10993 Part 10 (skin irritation and sensitization) Medical FDA guidance: gloves â¢ Latex gloves: ASTM D3578:2005 â¢ Vinyl gloves: ASTM D5250:2000e4 â¢ Surgeonsâ gloves: ASTM D3577:2001ae2 â¢ Biocompatibility testing: ISO 10993 Part 10 â¢ Powder-free: ASTM D6124:2001 â¢ Reduced protein level: ASTM D5712:2005e1; ASTM D6499: 2003; ASTM D 3578:2005 Eye OSHA compliance (29 CFR 1910.133): protection â¢ 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. a For all PPE subject to FDA regulations, requirements include establishment registration and adherence to manufacturing quality and labeling regulations.