Standards for Gowns
At Paradigm Textiles, we have tested and continue to test many of our products and we identify them as such. We do not test for Level 1 gowns at this time. However if a test comes back identifying a gown as a Level 1 gown we will label it as such. However, we use a 3rd party Independent Laboratory that is a U.S. Government QLL Certified testing laboratory to certify our products to meet ANSI/AAMI (American National Standards Institute/Association of the Advancement of Medical Instrumentation) standards on all other gowns and materials.
Labeling that shows a product has been tested to and meets appropriate performance standards is one way for users and procurers to determine when to use a particular gown.
- Level 1: Minimal risk, to be used, for example, during basic care, standard isolation, cover gown for visitors, or in a standard medical unit
- Level 2: Low risk, to be used, for example, during blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab
- Level 3: Moderate risk, to be used, for example, during arterial blood draw, inserting an Intravenous (IV) line, in the Emergency Room, or for trauma cases
- Level 4: High risk, to be used, for example, during long, fluid intense procedures, surgery, when pathogen resistance is needed or infectious diseases are suspected (non-airborne)
Regardless of how the product is named (that is, isolation gown, procedure gown, or cover gown), when choosing gowns, look for product labeling that describes an intended use with the desired level of protection based on the above risk levels. Product names are not standardized.
The performance of gowns is tested using consensus standards:
American Society for Testing and Materials (ASTM) F2407 is an umbrella document which describes testing for surgical gowns: 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 (non-woven), 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 (non-woven), ASTM D737-75
American National Standards Institute (ANSI) and the Association of the Advancement of Medical Instrumentation (AAMI): ANSI/AAMI PB70:2003 describes liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
Conformance with recognized consensus standards is voluntary for a medical device manufacturer. A manufacturer may choose to conform to applicable recognized standards or may choose to address relevant issues in another manner. Some manufacturers do not test their products.