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:
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D3577 |
Specification for Rubber Surgical Gloves |
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D3578 |
Specification for Rubber Examination Gloves |
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D5151 |
Test Method for Detection of Holes in Medical Gloves |
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D5250 |
Specification for Poly(Vinyl Chloride) Gloves for Medical Application |
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D6124 |
Test Method for Residual Powder on Medical Gloves |
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D6319 |
Specification for Nitrile Examination Gloves for Medical Application |
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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 |
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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 |
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:
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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 requirements for masks and respirators:
|
702 |
Standard for Classification of Flammability of Wearing Apparel |
Another example of a relevant NFPA standard includes
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NFPA1999 |
Standard on Protective Clothing for Emergency Medical Operations |
