Barrier Performance and Physical Property.docx

TABLE 1 – Barrier Performance

Or

EN 20811

Viral Penetration Resistance

ASTM F1671

Or

ISO 16604

A

A

Pass AQL 4.0 Or ≥ 14 kPa at the critical zones defined in ANSI/AAMI PB70

A Not required for this level.

TABLE 2 – Physical Properties

ASTM D5733 (non-woven)

or

A’ Appendix X1 provides a description of each method, its intended application, and limitations.

B’ Measurement of tensile and tear strength properties may not be indicative of snag or puncture resistance. There are no generally accepted test methods for snag or puncture resistance available at this time."

C’ This specification follows industry practice for reporting strength properties in both material directions (warp and fill, machine and cross-machine, or wales and course as specified by the manufacturer) to provide the end user with a comparison of material performance because a material may have different strengths associated with each direction of its manufacture."

D’ Results from lint testing are highly operator and equipment dependent. It is recommended that data be collected using a single piece of equipment, using a single operator, and on the same day to minimize variability."

E’ This specification permits reporting either evaporative resistance or water vapor transmission rate. Appendix X1 provides a comparison of the two methods with their respective procedures, application, and limitations. Garment comfort is a function of several factors, including but not limited to, fabric “breathability,” garment design, weight, fabric stiffness, the degree of garment fit on the individual wearer, and other possible individual wearer preferences (for example, noise, odor). Due to the complexity of these factors the best assessment of overall gown comfort can be made through actual wear tests. Measuring the breathability of the fabrics used to construct surgical gowns is one method of predicting thermal comfort. Those gowns that are designed and constructed of materials which more freely allow evaporation of perspiration and body heat transfer provide better thermal comfort. When gowns are constructed or reinforced with different materials in the critical and non-critical zones then testing the breathability of all the materials is important to help gain an understanding of the impact of overall garment design on thermal comfort. Comparisons of breathability between different surgical gowns (or gown materials) should only be made using the same test method. Also included in Appendix X1 are other potential factors that can affect comfort."