C
PPE-Related Standards and Regulations

TABLE C-1 Overview of PPE-Related Standards and Regulations

Surgical respirators

FDA guidance:a

 

  • 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 respirators

OSHA compliance:

 

  • NIOSH certification—tested to meet criteria outlined in 42 CFR 84

  • Comprehensive respirator program that includes annual fit testing

Surgical masks

FDA guidance:

 

  • 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



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OCR for page 181
C PPE-Related Standards and Regulations TABLE C-1 Overview of PPE-Related Standards and Regulations FDA guidance:a Surgical • NIOSH certification—tested to meet criteria outlined respirators 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: • NIOSH certification—tested to meet criteria outlined respirators in 42 CFR 84 • Comprehensive respirator program that includes annual fit testing Surgical FDA guidance: • Particulate filtration: ASTM F1215:1989 masks • 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

OCR for page 181
182 PREPARING FOR AN INFLUENZA PANDEMIC Surgical FDA guidance: • Barrier performance: ANSI-AAMI PB70:2003 gowns 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 • 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 • Flammability: 16 CFR 10, UL 2154 • Sterilization method and validation • Biocompatibility testing: ISO 10993 Part 10 (skin irritation and sensitization) Medical FDA guidance: • Latex gloves: ASTM D3578:2005 gloves • Vinyl gloves: ASTM D5250:2000e4 • Surgeons’ gloves: ASTM D3577:2001ae2 • Biocompatibility testing: ISO 10993 Part 10 • Powder-free: ASTM D6124:2001 • Reduced protein level: ASTM D5712:2005e1; ASTM D6499: 2003; ASTM D 3578:2005 OSHA compliance (29 CFR 1910.133): Eye • ANSI standard Z87.1-1989 (for devices purchased protection 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.