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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