What is the standard of medical gowns? 2 differences between USA and EU standards

standard of medical gowns

What is the standard of medical gowns? 2 differences between USA and EU standards

Medical gowns are used in health care facilities. They are used to protect the wearer from the spread of illness or infection. If the gown wearer comes in contact with potentially infectious liquid and solid material. Also, they may be used to help prevent the wearer from transferring microorganisms that could harm vulnerable patients, such as those with weakened immune systems patients.

There are many terms that have been used to refer to gowns intended for use in health care facilities, include” isolation gowns, surgical isolation gowns, surgical gowns, nonsurgical gowns, procedural gowns, and operating room gowns.”

What is the difference between the standards of American and European isolation gown?

Medical Gown Standard
USA Standard EU Standard
Standard Classification Standard Classification
 

ANSI/AAMI

PB70

Level 1  

EN 13795

Standard

Performance

Level 2
Level 3 High Performance
Level 4

 

What are the Standards for Gowns?

The performance of gowns is tested using American Society for Testing and Materials (ASTM) F2407 standards.

ASTM F2407 is an umbrella document which describes testing for surgical gowns:
tear resistance, seam strength, lint generation, evaporative resistance, and water vapor transmission.

A summary of ASTM F2407 standard recognized by the FDA.

  • Lint Generation : (ISO 9073 Part 10)
  • Tensile Strength : ASTM D5034, ASTM D1682
  • Seam Strength : ASTM D751 (stretch woven or knit)
  • Tear resistance : ASTM D5587(woven), ASTM D5587 (nonwoven), ASTM D1424
  • Water vapor transmission : (breathability) ASTM F1868 Part B, ASTM D6701 (nonwoven), ASTM D737-75

 

U.S. Standard of Gowns

These standards are established by AAMI (The Association for the Advancement of Medical
Instrumentation). ANSI (American National Standards Institute)/AAMI PB70:2012
is the standard that establishes a classification system ( levels 1, levels 2, levels 3, levels 4 ) for protective apparel used in health care facilities, including surgical gowns, based on liquid barrier performance using standardized test methods.

  • Level 1 : Minimal risk, to be used, for example, during basic care, standard isolation, a cover gown for visitors, or in a standard medical unit
  • Level 2 : Low risk, to be used, for example, during the blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab
  • Level 3 : Moderate risk, to be used, for example, during the 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)

The U.S. Food and Drug Administration (FDA) has adopted

ANSI/AAMI PB70:2012 as the standard by which all surgical gown manufacturers must abide.

 

What is ANSI/AAMI PB70?

The ANSI/AAMI PB70 standard includes 4 standard tests to evaluate standards for liquid barrier performance, with ratings for different levels of gown protection.

Based on the results of these standardized tests, we can see a table below of summarizes the requirements of ANSI/AAMI PB70:2012.

 

ANSI/AAMI PB70 Barrier Performance

 

Test method

 

 

Test definition

 

Result

 

Anticipated Barrier Effectiveness

AAMI Level 1 AATCC 42 Impact Penetration Water Water impact

< 4.5 g

Minimal water resistance (some resistance to water spray)
AAMI Level 2 AATCC 42 Impact Penetration Water Spray impact

< 1.0 g

Low water resistance (resistant to water spray and some resistance to water penetration under constant contact with increasing pressure)
AATCC 127 Hydrostatic Pressure Hydrostatic Pressure

> 20 cm

AAMI Level 3 AATCC 42 Impact Penetration Water Spray impact

< 1.0 g

Moderate water resistance (resistant to water spray and some resistance to water penetration under constant contact with increasing pressure)
AATCC 127 Hydrostatic Pressure Hydrostatic Pressure

> 50 cm

AAMI Level 4 ASTM F1670 Synthetic Blood Penetration Test (for surgical drapes)  

Surrogate Blood

 

 

no penetration at 2 psi(13.8 kPa)

Blood and viral penetration resistance (2 psi)
ASTM F1671 Viral Penetration Test (for surgical and isolation gowns)  

 

Bacteriophage

Phi-X174

 

 

no penetration at 2 psi(13.8 kPa)

 

EU Standard of Gowns

EN 13795 is a European recognized standard of quality and conformance to testing, manufacturing and performance specifications for single-use and reusable covering products.

The categorizes products by performance type:

  • Standard Performance : Non-reinforced or fabric-reinforced for low to medium risk of exposure
  • High Performance : Poly-reinforced for high risk of exposure

 

What is EN13795?

EN 13795 is an EU recognized harmonized standard.

EN 13795 specific performance requirements for gowns. In addition to these tests, EN 13795 requires other characteristics be tested, including microbial and particulate matter cleanliness, linting, bursting strength (dry and wet), and tensile strength (dry and wet). However, performance requirements for these characteristics are the same for both standard-performance and high-performance gowns, and critical and less-critical areas.

We can see a table below of summarizes the requirements of EN 13795.

 

 

Characteristic

 

 

Test Method

 

 

Unit

Standard Performance High Performance
Critical

product area

Less critical

product area

Critical

product area

Less critical

product area

Resistance to liquid penetration EN 0811 cm H2O ≥20 ≥10 ≥100 ≥10
Resistance to microbial penetration— dry EN ISO 22612 CFU N/A ≤3001 N/A ≤3001
Resistance to microbial penetration—wet EN ISO 22610 IB ≥2.8 N/A 6.02 N/A
Test conditions: challenge concentration 108 CFU/g talc, and 30 min vibration time.

2 IB = 6.0 for the purpose of the European Standard means: no penetration.

IB = 6.0 is the maximum achievable value.

 

Conclusion

Overall, the main difference between the gowns is their resistance to water and other fluids that may arise. The standard was developed to assist healthcare professional workers in making informed decisions when selecting the appropriate product for the anticipated tasks by specifying a consistent basis for testing and providing a common understanding of barrier properties. Make sure you request the technical data information from your manufacturer!

 

Reference

  1. Medical gown. (2021, January 13). U.S. FOOD & DRUG ADMINISTRATION. https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gowns#g5
  2. Selecting Protective Clothing. (2020, April 9). Centers for Disease Control and Prevention. https://www.cdc.gov/niosh/npptl/topics/protectiveclothing/#table3

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