D
Examples of Relevant Voluntary Consensus Standards

ASTM International standards are used extensively by the Food and Drug Administration (FDA) for 510k submissions of personal protective equipment (PPE). Examples of standards relevant to PPE used by healthcare workers include the following:

D3577

Specification for Rubber Surgical Gloves

D3578

Specification for Rubber Examination Gloves

D5151

Test Method for Detection of Holes in Medical Gloves

D5250

Specification for Poly(Vinyl Chloride) Gloves for Medical Application

D6124

Test Method for Residual Powder on Medical Gloves

D6319

Specification for Nitrile Examination Gloves for Medical Application

D6499

Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products

D6977

Specification for Polychloroprene Examination Gloves for Medical Application

F1671

Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi

X174

Bacteriophage Penetration as a Test System

F1862

Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)

F2101

Standard Test Method for Evaluating the Bacterial Filtration Efficiency of Surgical Masks Using a Biological Aerosol of Staphylococcus aureus

F2407

Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities



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D Examples of Relevant Voluntary Consensus Standards ASTM International standards are used extensively by the Food and Drug Administration (FDA) for 510k submissions of personal protective equipment (PPE). Examples of standards relevant to PPE used by healthcare workers include the following: D3577 Specification for Rubber Surgical Gloves D3578 Specification for Rubber Examination Gloves D5151 Test Method for Detection of Holes in Medical Gloves D5250 Specification for Poly(Vinyl Chloride) Gloves for Medical Application D6124 Test Method for Residual Powder on Medical Gloves D6319 Specification for Nitrile Examination Gloves for Medical Application D6499 Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products D6977 Specification for Polychloroprene Examination Gloves for Medical Application F1671 Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi- X174 Bacteriophage Penetration as a Test System F1862 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) F2101 Standard Test Method for Evaluating the Bacterial Filtration Efficiency of Surgical Masks Using a Biological Aerosol of Staphylococcus aureus F2407 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities 177

OCR for page 177
178 PERSONAL PROTECTIVE EQUIPMENT FOR HEALTHCARE PERSONNEL American National Standards Institute (ANSI) ANSI has standards that include guidance to employers for the practice of respiratory protection, but not the devices themselves. These include the following: Z88.2 Practices for Respiratory Protection Z88.6 Medical Qualifications of Respirator Wearers Z88.10 Fit-Test Requirements for Respiratory Protection The Occupational Safety and Health Administration has incorporated the following ANSI standard into its eye and face protection standard (Code of Federal Regulations 1919.133): Z87.1 Standard Practice for Occupational and Educational Eye and Face Protection Association for Advancement of Medical Instrumentation (AAMI) AAMI has a standard for fluid resistance of gowns worn by healthcare workers. Minimum performance levels ranging from 1 (least protective) to 4 (most protective) have been determined. These levels apply to the product’s Critical Zone, including seams, but excluding cuffs, hems, and bindings. National Fire Protection Association (NFPA) Standards The FDA includes the following NFPA standard into its require- ments for masks and respirators: 702 Standard for Classification of Flammability of Wearing Apparel Another example of a relevant NFPA standard includes NFPA1999 Standard on Protective Clothing for Emergency Medical Operations