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Suggested Citation:"Appendix D: Examples of Relevant Voluntary Consensus Standards." Institute of Medicine. 2011. Preventing Transmission of Pandemic Influenza and Other Viral Respiratory Diseases: Personal Protective Equipment for Healthcare Personnel: Update 2010. Washington, DC: The National Academies Press. doi: 10.17226/13027.
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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

Suggested Citation:"Appendix D: Examples of Relevant Voluntary Consensus Standards." Institute of Medicine. 2011. Preventing Transmission of Pandemic Influenza and Other Viral Respiratory Diseases: Personal Protective Equipment for Healthcare Personnel: Update 2010. Washington, DC: The National Academies Press. doi: 10.17226/13027.
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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 requirements 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

Suggested Citation:"Appendix D: Examples of Relevant Voluntary Consensus Standards." Institute of Medicine. 2011. Preventing Transmission of Pandemic Influenza and Other Viral Respiratory Diseases: Personal Protective Equipment for Healthcare Personnel: Update 2010. Washington, DC: The National Academies Press. doi: 10.17226/13027.
×
Page 177
Suggested Citation:"Appendix D: Examples of Relevant Voluntary Consensus Standards." Institute of Medicine. 2011. Preventing Transmission of Pandemic Influenza and Other Viral Respiratory Diseases: Personal Protective Equipment for Healthcare Personnel: Update 2010. Washington, DC: The National Academies Press. doi: 10.17226/13027.
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Page 178
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In 2009, the H1N1 influenza pandemic brought to the forefront the many unknowns about the virulence, spread, and nature of the virus, as well as questions regarding personal protective equipment (PPE) for healthcare personnel. In this book, the Institute of Medicine assesses the progress of PPE research and identifies future directions for PPE for healthcare personnel.

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