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Preparing for an Influenza Pandemic: Personal Protective Equipment for Healthcare Workers
C PPE-Related Standards and Regulations
TABLE C-1 Overview of PPE-Related Standards and Regulations
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OCR for page 181
Preparing for an Influenza Pandemic: Personal Protective Equipment for Healthcare Workers
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
OCR for page 182
Preparing for an Influenza Pandemic: Personal Protective Equipment for Healthcare Workers
Surgical gowns
FDA guidance:
Barrier performance: ANSI-AAMI PB70:2003
4 levels of performance based on AATCC 42:2000 and ASTM F1671:2003
Fluid resistance: ASTM F1670-03
Bloodborne pathogens resistance: ASTM F1671-03
Non-barrier properties
Snag resistance: ASTM D5587:1996 and ASTM D2582:2000
Grab tensile strength: ASTM D5034:1995
Linting: IST 160.1:1995
Heat loss: ASTM F1868:1998, Part C
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 gloves
FDA guidance:
Latex gloves: ASTM D3578:2005
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
Eye protection
OSHA compliance (29 CFR 1910.133):
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.
aFor all PPE subject to FDA regulations, requirements include establishment registration and adherence to manufacturing quality and labeling regulations.
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