Selecting the right medical gowns and isolation gowns is critical for ensuring healthcare safety. For procurement teams, ensuring regulatory compliance and accurately matching protection levels to clinical risks is paramount. Whether your facility follows AAMI PB70 (the US standard) or EN 13795 (the EU standard), understanding these frameworks prevents costly errors and protects frontline staff. In this guide, we compare AAMI Level 1-4 with European high-performance ratings to help infection control and purchasing departments make informed, data-driven decisions.

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.”

Understanding Gown Classifications: Surgical vs. Isolation Gowns

Healthcare facilities utilize a variety of protective garments, primarily categorized into isolation gowns and surgical gowns. While both serve to prevent the transfer of microorganisms and protect vulnerable patients (such as those with weakened immune systems), their regulatory and testing requirements differ significantly.

Surgical gowns are strictly regulated. In the United States, they often require FDA 510(k) clearance as Class II medical devices and must provide comprehensive protection in critical zones during invasive procedures. The overarching performance of surgical gowns is evaluated using the ASTM F2407 umbrella standard, which dictates rigorous testing for metrics like tear resistance, seam strength, lint generation, and breathability.

Conversely, isolation gowns offer varying levels of coverage depending on the anticipated risk of fluid exposure, making it crucial to select the exact specification required for the intended clinical environment.

AAMI PB70: The US Standard for Level 1 to Level 4 Protective 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.

To assist procurement in matching products to specific clinical applications, AAMI defines four levels of protection:

• AAMI Level 1 (Minimal Risk): Demonstrates minimal water resistance to spray. Suitable for basic care, standard medical units, or as a cover gown for visitors.

• AAMI Level 2 (Low Risk): Resists water spray and some penetration under constant pressure. Ideal for standard blood draws, suturing, pathology labs, and general care within the Intensive Care Unit (ICU).

• AAMI Level 3 (Moderate Risk): Offers moderate resistance to liquid penetration. Required for arterial blood draws, inserting an intravenous (IV) line, Emergency Room (ER) procedures, and trauma cases.

• AAMI Level 4 (High Risk): Provides complete blood and viral penetration resistance. Mandatory for long, fluid-intense surgical procedures, and when managing suspected infectious diseases (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? Technical Barrier Performance

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.

EN 13795: The EU Standard for Single-Use & Reusable Gowns

In the European market, EN 13795 is the recognized harmonized standard evaluating the quality, manufacturing, and performance specifications for both single-use and reusable surgical covering products.

Rather than a four-tier numbered system, EN 13795 categorizes products by performance type, specifically differentiating between critical and less-critical product areas:

• Standard Performance: Non-reinforced or fabric-reinforced gowns engineered for low to medium risk of exposure.

• High Performance: Poly-reinforced gowns engineered to withstand high risk of fluid exposure.

In addition to liquid barrier testing, EN 13795 evaluates microbial cleanliness, particulate matter, linting, bursting strength, and tensile strength to ensure comprehensive durability.

EN 13795 Performance Requirements Summary

Summary: 2 Critical Differences Between US and EU Standards

1. Classification Approach: The US AAMI PB70 standard utilizes a four-tier system (Level 1 to Level 4) based purely on escalating liquid barrier performance. The EU EN 13795 standard categorizes gowns by “Standard” or “High” performance, factoring in the specific construction (critical vs. less-critical areas) and intended reuse (single-use vs. reusable).

2. Testing Methodologies: While both evaluate liquid and microbial resistance, they rely on different testing bodies. AAMI leans heavily on AATCC and ASTM methods (e.g., measuring hydrostatic pressure in cm and viral penetration at 2 psi), whereas the EU standard utilizes EN and ISO testing methodologies to measure similar variables.

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!

Frequently Asked Questions (FAQ)

Q: Is an EN 13795 “High Performance” gown the exact equivalent of an AAMI Level 4 gown? A: Not directly. While both are designed for high-risk, fluid-heavy procedures, AAMI Level 4 strictly requires passing the ASTM F1671 viral penetration test. EN 13795 High Performance tests for wet microbial penetration (EN ISO 22610), but compliance teams should cross-reference specific viral barrier data when substituting standards.

Q: Does my facility need FDA 510(k) clearance for all gowns? A: No. In the US, surgical gowns intended for operating rooms generally require FDA 510(k) clearance as Class II devices. Basic isolation gowns used for minimal risk (Level 1) are often classified as Class I and may be exempt from premarket notification, provided they meet specific manufacturing controls.

Q: How do I verify a supplier’s AAMI or EN rating? A: Procurement must always request independent third-party laboratory test reports. A simple label stating “Level 3” is insufficient without the corresponding test data validating the AATCC 42 and 127 results.

References & Regulatory Compliance Sources

• FDA: Medical Gowns Regulatory Requirements

• CDC/NIOSH: Strategies for Optimizing the Supply of Isolation Gowns

• AAMI: ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel.

• ASTM International: ASTM F2407 Standard Specification for Surgical Gowns.

• CEN: EN 13795-1-2019 Surgical clothing and drapes requirements.

Medtecs Medical Gowns(Isolation Gown)

AAMI Level 1 SMMS 22gsm Isolation Gown

AAMI Level 2 SMMS 25gsm Isolation Gown

AAMI Level 3 PE Isolation Gown

AAMI Level 4 PP+PE 36gsm Isolation Gown with Tape

AAMI Level 4 PP+PE 63gsm Isolation Gown with Tape

Chemo Gown

Surgical Gown

Reusable Gown

Medtecs Group — Global Custom Isolation Gown Manufacturing & Factory OEM/ODM Services

• BY Protection Level (AAMI) Isolation Gowns:

  AAMI Level 1 Isolation Gowns,

  AAMI Level 2 Isolation Gowns,

  AAMI Level 3 Isolation Gowns,

  AAMI Level 4 Isolation Gowns,

  Yellow AAMI Level 4 Isolation Gowns

• BY Color Isolation Gowns:

  Blue Isolation Gowns,

  White Isolation Gowns,

  Yellow Isolation Gowns

• BY Sterility Isolation Gowns:

  Non-Sterile Isolation Gowns

• BY Feature Isolation Gowns:

  Isolation Gowns with Knit Cuffs,

  Tie Neck Isolation Gowns,

  Isolation Gowns with Thumb Loops

• BY Compliance Standard Isolation Gowns:

  FDA 510(k) Cleared Isolation Gowns,

  ASTM F1670 Compliant Isolation Gowns (Synthetic Blood),

  ASTM F1671 Compliant Isolation Gowns (Viral Penetration)

• BY Fabric Weight (GSM) Isolation Gowns:

  25 gsm Isolation Gowns,

  36 gsm Isolation Gowns,

  63 gsm Isolation Gowns

• BY Back Style Isolation Gowns:

  Open Back Isolation Gowns,

  Over-the-Head Design Isolation Gowns

• BY Material Isolation Gowns:

  SMS Isolation Gowns,

  PE Coated Isolation Gowns,

  Microporous Laminate Isolation Gowns

• BY Usability Isolation Gowns:

  Disposable Isolation Gowns

• BY Seam Style Isolation Gowns:

  Isolation Gowns with Taped Seams

• BY Application / Use Case Isolation Gowns:

  Isolation Gowns for ICU(Intensive Care Unit),

  Isolation Gowns for ER (Emergency Room) & Trauma,

  Isolation Gowns for Decontamination,

  Isolation Gowns for Basic Patient Care & Visitor Use,

  Isolation Gowns for Long-Term Care Facilities

• BY Solution :

  ER & Trauma Center PPE: Impervious Gowns for High-Risk Surgery

  (

  Trauma Surgeons,

  Triage Nurses,

  ICU Staff,

  Procurement

  ), 

  USP Oncology PPE: Gowns & Gloves >480 Min Carmustine Protection

  (

  Pharmacy,

  Nursing,

  EVS,

  Procurement

  ), 

  Hospital CSSD Decontamination Biosafety Compendium

  (

  Technicians,

  Compliance Officers,

  OHS Personnel,

  Procurement

  )

Frequently Asked Questions