Views:0 Author:Site Editor Publish Time: 2020-08-03 Origin:Site
In medical institutions, isolation suits are considered to be the only second personal protective equipment after gloves. Isolation garments are defined by the Medical Instrument Development Association (AAMI) as protective clothing used to protect HCW and the transfer of microorganisms and body fluids in patients in isolation.
The main points are as follows:
What is The Isolation Gown?
Choosing Which Gown to Use
Standards for Gowns
A Isolation Gown is regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification. A Isolation Gown is a personal protective garment intended to be worn by health care personnel during surgical procedures to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, and particulate matter. Because of the controlled nature of surgical procedures, critical zones of protection have been described by national standards. As referenced in Figure 1: the critical zones include the front of the body from top of shoulders to knees and the arms from the wrist cuff to above the elbow. Isolation Gown can be used for any risk level (Levels 1-4). All Isolation Gown must be labeled as a Isolation Gown.
Isolation Gown are designed to protect patients and medical staff from cross-contamination, so when choosing Isolation Gown, protection is essential. However, uncomfortable Isolation Gown may put the entire operation at risk.
Breathable, soft, quiet and flexible materials enable employees to focus on the job at hand. Ergonomic elements improve the fit of the dress and provide greater freedom of movement.
American Society for Testing and Materials (ASTM) F2407 is an umbrella document which describes testing for Isolation Gown: tear resistance, seam strength, lint generation, evaporative resistance, and water vapor transmission.
Below is a summary of ASTM F2407 standard recognized by the FDA.
Tensile Strength: ASTM D5034, ASTM D1682
Tear resistance: ASTM D5587(woven), ASTM D5587 (nonwoven), ASTM D1424
Seam Strength: ASTM D751 (stretch woven or knit)
Lint Generation (ISO 9073 Part 10)
Water vapor transmission (breathability) ASTM F1868 Part B, ASTM D6701 (nonwoven), ASTM D737-75
PPE is an important part of the control hierarchy used to protect personnel in the hospital environment. Isolation garments are a key element of PPE, because they are the second highest PPE parts after gloves.We also provide Medical Protective Clothing, Radiation Protection Suit, contact us.