AAMI vs EN13795: What’s the Difference Between US and EU Surgical Gown Standards?
Healthcare professionals rely on medical isolation gowns and surgical gowns to protect against fluids, microorganisms, and contaminants during medical procedures. However, different regions follow different standards to evaluate the performance and safety of these gowns.
In the United States, surgical and isolation gowns are evaluated according to the AAMI PB70 standard, while in Europe the widely adopted regulation is EN13795.
For hospitals, distributors, and medical procurement teams, understanding these standards is essential when selecting the appropriate isolation gown standard, ensuring compliance, and choosing the right medical gown protection level.
This guide explains the key differences between AAMI gown levels and EN13795 surgical gown classifications, including testing methods, protection levels, and certification requirements.
What Is an Isolation Gown Standard?
An isolation gown standard defines the performance requirements that medical protective clothing must meet in order to provide adequate protection in healthcare environments.
These standards typically evaluate:
- Liquid barrier performance
- Microbial penetration resistance
- Material strength and durability
- Cleanliness and sterility
- Comfort and breathability
Medical gowns are commonly used in:
- Hospitals
- Surgical operating rooms
- Emergency departments
- Isolation wards
- Medical laboratories
The two most widely used international standards are:
- Association for the Advancement of Medical Instrumentation PB70 (United States)
- EN 13795 surgical gown standard (Europe)
Although both aim to protect healthcare workers and patients, their testing methods and classification systems differ significantly.
Overview of AAMI PB70 Surgical Gown Standard
The ANSI/AAMI PB70 standard is the primary guideline used in the United States for evaluating protective apparel used in healthcare settings.
It categorizes gowns into four levels of barrier protection, based on their resistance to liquid penetration.
AAMI Gown Protection Levels
| Level | Protection Type | Typical Use |
|---|---|---|
| Level 1 | Minimal risk | Basic patient care, visitor gowns |
| Level 2 | Low risk | Blood draw, suturing |
| Level 3 | Moderate risk | Arterial blood draw, trauma cases |
| Level 4 | High risk | Long fluid-intensive surgeries |
Level 1 Isolation Gown
Level 1 gowns provide minimal protection against small amounts of fluid exposure. These disposable isolation gowns are commonly used in basic medical care situations such as routine checkups or standard patient care.
Level 2 Isolation Gown
Level 2 gowns offer low fluid resistance and are suitable for procedures involving limited blood exposure. These gowns are frequently used in emergency departments and pathology labs.
Level 3 Isolation Gown
Level 3 gowns provide moderate fluid protection and are typically used during procedures with higher fluid exposure risks.
Level 4 Surgical Gown
Level 4 gowns offer the highest level of protection and must pass additional testing for viral penetration resistance, making them suitable for high-risk surgeries.
For more details about AAMI classifications, see: AAMI PB70 Isolation Gown Levels Explained: Level 1–4 Protection Guide
Overview of EN13795 Surgical Gown Standard
The European standard EN 13795 governs the performance requirements for surgical gowns, drapes, and clean air suits used in operating rooms.
This standard focuses heavily on microbial cleanliness and barrier performance in surgical environments.
Unlike the AAMI system, EN13795 divides products into two main categories:
- Standard Performance
- High Performance
These categories apply to surgical gowns and drapes used in operating rooms.
EN13795 Performance Classification
| Classification | Application |
|---|---|
| Standard Performance | Short surgical procedures |
| High Performance | Long or high-risk surgeries |
Standard Performance Surgical Gowns
These gowns provide basic barrier protection and are suitable for shorter surgical procedures with limited fluid exposure.
High Performance Surgical Gowns
High-performance gowns provide enhanced resistance to:
- Liquid penetration
- Microbial contamination
- Mechanical stress
They are designed for procedures involving significant fluid exposure or extended surgical duration.
For more details about European surgical gown regulations: EN13795 Surgical Gown Standard Explained
Key Differences Between AAMI and EN13795 Standards
Although both standards evaluate the safety and performance of medical gowns, their classification systems and testing focus differ significantly.
1. Protection Level Classification
One of the biggest differences is how protection levels are categorized.
AAMI PB70
- Four protection levels
- Based mainly on liquid barrier performance
EN13795
- Two performance classes
- Focus on surgical environment protection
In practical terms, AAMI provides more granular protection levels, while EN13795 focuses on operating room safety requirements.
2. Testing Methods
Both standards evaluate fluid resistance, but they use different testing protocols.
AAMI PB70 tests include:
- Impact penetration testing
- Hydrostatic pressure testing
- Viral penetration resistance (Level 4)
EN13795 testing focuses on:
- Microbial penetration (dry and wet)
- Cleanliness and particle release
- Mechanical strength
- Liquid barrier performance
Because of these differences, a gown that meets AAMI Level 3 may not automatically meet EN13795 high-performance classification.
3. Intended Application
Another key difference is the intended usage environment.
AAMI gowns are commonly used for:
- Isolation wards
- General patient care
- Emergency departments
EN13795 gowns are specifically designed for:
- Operating rooms
- Surgical procedures
- Sterile environments
Therefore, EN13795 surgical gowns are often used during operations, while AAMI-rated isolation gowns may be used in broader healthcare scenarios.
4. Certification and Regulatory Requirements
The isolation gown certification process also differs between regions.
United States
Medical gowns are regulated by the U.S. Food and Drug Administration.
Manufacturers typically must comply with:
- FDA registration
- AAMI PB70 testing
- ASTM performance requirements
European Union
In Europe, surgical gowns must comply with:
- EU Medical Device Regulation 2017/745
- EN13795 standard
- CE marking requirements
Hospitals and distributors in Europe typically require CE-certified surgical gowns that comply with EN13795.
Choosing the Right Medical Gown Protection Level
Selecting the appropriate medical gown protection level depends on the clinical environment and risk level.
Healthcare buyers typically consider the following factors:
1. Procedure Risk Level
Low-risk procedures may only require Level 1 or Level 2 isolation gowns, while surgical procedures often require Level 3, Level 4, or EN13795 high-performance gowns.
2. Fluid Exposure
Procedures with heavy fluid exposure require higher barrier protection.
3. Regulatory Requirements
Hospitals must comply with the regional isolation gown standard required in their country.
4. Comfort and Breathability
Long surgical procedures require gowns that balance protection with comfort and breathability.
Global Trends in Surgical Gown Standards
With increasing global trade in medical supplies, many manufacturers now produce gowns that comply with both AAMI and EN13795 standards.
This dual compliance allows medical suppliers to serve:
- North American hospitals
- European healthcare systems
- International medical distributors
Additionally, many healthcare facilities now prefer disposable nonwoven surgical gowns made from materials such as:
- SMS nonwoven fabric
- SMMS multilayer material
- Laminated microporous film
These materials provide improved fluid resistance, breathability, and comfort.
Internal Resources for Medical Gown Buyers
If you are evaluating medical isolation gowns for hospitals or distributors, these guides may help:
Recommended reading
- → Complete Guide to Medical Isolation Gowns: Types, Materials and Protection Levels
- → AAMI PB70 Isolation Gown Levels Explained: Level 1–4
- → EN13795 Surgical Gown Standard Explained
These articles provide detailed insights into selecting the right disposable isolation gown for different medical applications.
About Wellmien
Wellmien is a professional manufacturer and supplier of disposable medical protective products, including:
Our products are designed to meet international isolation gown certification standards, including AAMI PB70 and EN13795, and are widely used in hospitals, laboratories, and healthcare institutions worldwide.
With strong OEM capabilities and strict quality control, Wellmien supports global distributors, healthcare suppliers, and procurement organizations with reliable protective apparel solutions.