NIOSH Protective Clothing Standards and Specifications
Current Healthcare Protective Clothing Standards and Specifications
Several fluid-resistant and impermeable protective clothing options are available in the market place for healthcare workers. These include isolation gowns, surgical gowns, and coveralls. When selecting the most appropriate protective clothing, employers should consider all of the available information on recommended protective clothing, including the potential limitations. Employers should consult protective clothing manufacturers as needed in regards to availability and practicality for their facilities. A key step in this process is to understand the relevant standards and test methods. Descriptive information about each standard is provided in the body of this document.
Standard Test Methods to MEasure Blood and Viral Penetration Resistance
This technical report is structured to be as broad as possible in listing multiple test methods with minimum performance requirements in order to maximize the potential that an employer will find appropriate data from different manufacturers. However, it is important to note that different test methods, while similar, do not yield the same absolute results due to differences in test equipment, conditions, and procedures. These particular methods/standards have been selected because they are broadly used in the industry and current international protective clothing classification standards to describe the performance levels provided by garments and to differentiate the protection levels provided. Employers should be aware that garments qualifying under different standard methods may in fact provide different levels of protection. Limited information is available to compare different products using these test methods.
Standards are available to define the performance requirements for clothing or clothing materials used to protect against infectious agents. ANSI/AAMI PB70external icon, EN 13795, EN 14126, and NFPA 1999 are examples of standards frequently used in the United States and Europe. ANSI/AAMI PB70 is used to classify the garments used in the healthcare industry, such as surgical and isolation gowns. Typically, EN 14126 is used for protective coveralls, and EN 13795 is used for surgical gowns. NFPA 1999-2013 is primarily intended for emergency medical first responders, but its scope also covers medical first receivers.
Performance Requirements for Protective Clothing
This technical report is structured to be as broad as possible in listing multiple test methods with minimum performance requirements in order to maximize the potential that an employer will find appropriate data from different manufacturers. However, it is important to note that different test methods, while similar, do not yield the same absolute results due to differences in test equipment, conditions, and procedures. These particular methods/standards have been selected because they are broadly used in the industry and current international protective clothing classification standards to describe the performance levels provided by garments and to differentiate the protection levels provided. Employers should be aware that garments qualifying under different standard methods may in fact provide different levels of protection. Limited information is available to compare different products using these test methods.
Standards are available to define the performance requirements for clothing or clothing materials used to protect against infectious agents. ANSI/AAMI PB70external icon, EN 13795, EN 14126, and NFPA 1999 are examples of standards frequently used in the United States and Europe. ANSI/AAMI PB70 is used to classify the garments used in the healthcare industry, such as surgical and isolation gowns. Typically, EN 14126 is used for protective coveralls, and EN 13795 is used for surgical gowns. NFPA 1999-2013 is primarily intended for emergency medical first responders, but its scope also covers medical first receivers.
ANSI/AAMI PB70:2012 -“Liquid Barrier performance and classification of protective apparel and drapes intended for healthcare facilities”
In the United States, ANSI/AAMI PB70 establishes a system of classification for protective apparel (including surgical gowns and isolation gowns) used in healthcare facilities, based on their liquid barrier performance. It also specifies labeling requirements and test methods for determining the compliance of protective apparel labeled with liquid barrier claims or liquid-borne microbial barrier claims. The ANSI/AAMI PB70 was accepted by the FDA in 2004.
The ANSI/AAMI PB70 standard includes four standard tests to evaluate the barrier effectiveness of surgical gowns, isolation gowns, and surgical drapes. Based on the results of these standardized tests, four levels of barrier performance are defined, with Level 1 being the lowest level of protection, and Level 4 being the highest level of protection.
NFPA 1999- “Standard on Protective Clothing for Emergency Medical Operators”
NFPA 1999 was specifically developed to address a range of different clothing items worn by emergency medical service first responders, but also applies to medical first receivers. The standard includes design criteria, performance criteria, labeling requirements, and test methods that address both single-use (disposable) and multiple-use (reusable) emergency medical garments, which can be coveralls, multi-piece clothing sets, or partial body clothing. The standard uses ASTM F1671 to demonstrate the viral penetration resistance of materials and seams, which is supplemented with an overall liquid integrity test for full body clothing. The latter test shows whether closures and other aspects of the clothing item design will hold out liquid. There are also testing requirements applied to materials and seams for setting minimum criteria such as strength and physical hazard resistance. The standard further specifies that compliant clothing items be labeled as compliant to the standard and certified by an independent certification organization.
Comparison of Test Methods and Classification Standards for Gowns and Coveralls
Several test methods and performance requirements for barrier resistant gowns and coveralls were discussed in this technical document. Test methods for determination of the barrier resistance of fabrics such as AATCC 42, AATCC 127, ASTM F1670, ASTM F1671, ISO 16603, ISO 16604, are used for both coveralls and gowns. In general, for the classification of the protective clothing, ANSI/AAMI PB70 and EN 13795 are used for gowns and EN 14126 and NFPA 1999 are used for coveralls.
There are several differences between ANSI/AAMI PB70 and EN 13795 surgical gown classifications. Because the test methods and performance requirements cannot be compared directly, it is difficult to assign equivalency between surgical gowns classified according to ANSI/AAMI PB70 and EN 13795 . Recent PPE specifications from the World Health Organizationpdf for Filovirus disease outbreak indicate that EN 13795 high performance level gown is most similar to ANSI/AAMI PB70 level 3 gown.
Similarly, for coveralls it is difficult to compare test methods and performance specifications directly. In Europe, the EN 14126 standard typically is used to evaluate and classify coveralls used to protect from infectious agents and EN 13795 is used to evaluate and classify surgical gowns. Unlike surgical or isolation gowns (ANSI/AAMI PB70), there is no widely used classification standard in the United States. Coveralls with materials and seams tested against ASTM 1671 are specified in NFPA 1999–2013, Standard on Protective Clothing for Emergency Medical Operations. This standard establishes minimum performance requirements for single-use emergency medical garments, multiple-use emergency medical garments, and other PPE for protection from contact with blood and body-fluid-borne pathogens for personnel performing patient care during emergency medical operations [NFPA 2013]. While originally designed for pre-hospital healthcare workers, it could be used for hospital-based healthcare workers as well.
