Medical Isolation Gown Materials and Performance Standards

Medical isolation gown are one of the main types of isolation gown, which are mostly used in the medical industry where there may be contact with microorganisms. They can effectively resist the threats of external microorganisms and protect medical staff from harm. Currently, medical isolation gown on the market use various materials, but regardless of the material used, they must meet certain requirements.

Types of medical isolation gown materials

Coating materials. Most enterprises use wet or dry polyurethane, polyacrylic acid ester, or polyvinylidene fluoride to coat fabrics and then use this fabric to make isolation gown.

PU, TPU film composite materials. This composite material has certain improvements in breathability and comfort compared to coating materials.

PTFE microporous resin composite material. The military has a small amount of application on special military clothing in some specific branches. Its application on medical isolation gown is still in the research and trial stage. The microporous thin film of polytetrafluoroethylene can effectively solve the two major problems of coating materials and PU, TPU film composite materials' poor durability and less-than-ideal breathability.

Performance evaluation standards of medical isolation gown materials

Protection

The evaluation methods of protective performance mainly include static water pressure, splash test, impact infiltration, spray, blood penetration, and microbial penetration and particle filtration efficiency.

GB19082-2003 stipulates that the water repellency level should not be lower than GB3 level, and the static water pressure requires no infiltration of 17cm H2O. Synthetic blood should not penetrate the isolation suit material. EN13795 stipulates that the low-risk zone of standard performance and high-risk zone's dry-state microbes passed through no more than 2a, cLog(CFU), while the wet-state microbes passed through more than 2.8b/B. Surgical gowns and surgical aperture towels are classified into standard performance and high performance, with each performance divided into high-risk areas and low-risk areas. Level 4 surgical gowns require no blood penetration, and the surgical aperture towels require no phage penetration. NFPA1999 requires no water seepage during the spray test, no phage penetration in the virus penetration test, and a spatter rate of ≥70% in the spray test.

Comfort

As a material for wearing, the comfort of isolation suit materials is affected by many factors, including breathability, water vapor permeability, sagging, quality, surface thickness, static electricity performance, color, reflectivity, odor, skin sensitization, and the design and sewing in the garment-making process. The primary evaluation indicators include air permeability, moisture permeability, and charge density. NFPA1999 stipulates that the overall heat dissipation should be ≥450w/㎡, GB19082 requires moisture permeability ≥2500G/m2*d, and the electrostatic charge density should be ≤0.6uC. YY/T0506 requires that medical surgical gowns and aperture towel materials have air permeability performance, with a unit of specific indicators stipulated for the material.

Physical and mechanical properties

The evaluation methods for the physical and mechanical properties of isolation suit materials mainly include breaking strength, bursting strength, and puncture strength. EN13795 stipulates that the dry-state bursting strength is ≥40N, the wet-state bursting strength in the high-risk area is ≥40N, and there is no requirement in the low-risk area. The dry-state breaking strength is ≥20N, and the wet-state breaking strength in the high-risk area is ≥20N, and there is no requirement in the low-risk area. GB19082 stipulates that the breaking strength is ≥45N, and the breaking elongation is ≥30%. NFPA1999 stipulates that each layer has a breaking strength of ≥135N, and each leading guide has a bursting strength of ≥34Kpa, a puncture strength of ≥25N, a tear strength of ≥36N, and a cracking strength of ≥67N/50mm.

In addition, GB19082 has made regulations on the skin irritation, residual ethylene oxide, flame retardancy, and disinfection resistance of medical isolation gown materials.