What is AAMI PB70, the standard for medical gowns?
The AAMI PB70 standard (ANSI/AAMI PB70:2012) is the benchmark for liquid barrier performance of medical gowns and drapes in North America. For procurement managers in Canadian healthcare, understanding the differences between isolation gown levels is essential for making cost-effective, compliance-driven purchasing decisions. This guide breaks down Level 1, 2, 3, and 4 barriers and explains where each level belongs in your facility.
What are the four AAMI PB70 protection levels?
AAMI PB70 classifies gowns based on their resistance to liquid penetration. The classification is determined by standardized tests for water impact penetration and hydrostatic pressure:
Understanding AAMI PB70 Testing Standards
| Level | Barrier Performance | Test Standard | Typical Applications |
|---|---|---|---|
| Level 1 | Minimal fluid resistance | AATCC 42 (water impact) — ≤4.5 g penetration | Standard precautions, basic patient care, visitor use |
| Level 2 | Low fluid resistance | AATCC 42 — ≤1.0 g + AATCC 127 (hydrostatic) — ≥20 cm | Blood draw, suturing, ICU care, trauma assessment |
| Level 3 | Moderate fluid resistance | AATCC 42 — ≤1.0 g + AATCC 127 — ≥50 cm | Surgery, arterial blood draws, trauma response, ER procedures |
| Level 4 | High fluid resistance (impervious) | ASTM F1671 — viral penetration resistance | High-risk surgical procedures, infectious disease outbreaks (Ebola, etc.) |
Level 1 isolation gowns from CliniEco Medical — designed for standard precautions and basic patient care.
Matching Gown Level to Clinical Application
When should you use Level 1 isolation gowns?
Level 1 isolation gowns are the entry-level protection tier under AAMI PB70. They provide minimal fluid resistance and are suitable for:
Cost Considerations for Canadian Facilities
- Standard contact precautions
- Basic patient care (bathing, dressing changes on non-infected wounds)
- Visitors and administrative staff in clinical areas
- Low-risk environments where fluid exposure is minimal
Level 1 gowns are the most economical option and are widely used in long-term care, dental clinics, and outpatient settings. They are typically made from non-woven polypropylene or SMS (spunbond-meltblown-spunbond) materials.
When do Level 2 and Level 3 gowns give higher protection?
Level 2 gowns offer low fluid resistance with tested hydrostatic pressure of at least 20 cm. They are appropriate for:
- Blood draws and IV insertions
- Suture removal and minor wound care
- ICU patient care with moderate splash risk
- Clinical laboratory work
Level 3 gowns provide moderate fluid resistance (≥50 cm hydrostatic pressure) and are the standard choice for:
- Minor surgical procedures
- Arterial blood gas draws
- ER trauma response with moderate fluid exposure
- N95 mask or PAPR use with airborne precautions
How do you choose the right gown level for your facility?
When selecting disposable gowns Canada for your healthcare facility, consider these factors:
- Risk assessment: Match gown level to the specific procedures being performed.
- Cost vs. protection: Level 1 gowns cost 30–50% less than Level 3. Don't over-specify protection levels.
- Comfort and breathability: Higher-level gowns use thicker materials that may be less comfortable for long wear.
- Size and fit: Ensure the gowns you select come in multiple sizes for adequate coverage.
- Regulatory compliance: Verify that gowns carry AAMI PB70 certification documentation from the manufacturer.
How do surgical gown standards differ from isolation gowns?
It's important to distinguish between isolation gown levels (AAMI PB70) and surgical gown standards. Surgical gowns follow ASTM F2407 and are classified differently based on their intended use in sterile surgical fields. Isolation gowns, by contrast, are designed for non-sterile patient care and contact precautions. Both may reference AAMI PB70 for liquid barrier testing, but surgical gowns have additional requirements for sterility, linting, and seam strength.
What does compliance require in Canadian healthcare?
Canadian healthcare facilities should reference provincial IPAC guidelines and CSA Z317.10 standards for gown selection. Many health authorities now require AAMI PB70-rated gowns exclusively, moving away from unrated alternatives. CliniEco Medical offers AAMI PB70 Level 1 isolation gowns in both standard and PLA biodegradable options, providing Canadian healthcare facilities with compliant, cost-effective PPE. Explore isolation gowns at CliniEco.ca.
Related Reading
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Related reading: explore our infection control resources for clinics.
decode HAI, SSI, CJD and MDRO acronyms in our infection control pillar article.
Frequently Asked Questions
What are AAMI level gowns?
AAMI level gowns are graded by ANSI/AAMI PB70, the North American standard for liquid barrier performance in medical gowns. Level 1 covers minimal-risk care and visitor use; Level 2 low-risk tasks such as blood draw, suturing and lab work; Level 3 moderate-risk work such as arterial blood draw, IV insertion and emergency trauma; Level 4 high-risk, fluid-intensive procedures including surgery. Canadian clinics usually standardise on Level 2 or Level 3 for routine work. The level appears on the case label and the neck label of the gown - our SMMS 40gsm Level 2 gown states it on both.
What does AAMI 1135:2014 mean, and is that AAMI Level 3?
AAMI 11135:2014 is not a gown level, and the two standards are easy to confuse. ANSI/AAMI/ISO 11135:2014 covers ethylene oxide sterilization of health care products and says nothing about barrier performance. Gown levels come from ANSI/AAMI PB70, which ranks gowns Level 1 to Level 4 by how the fabric resists water and blood penetration. If a supplier quotes 11135 when you asked about gown protection, ask instead for the PB70 level, the fluid-resistance test result, and the shelf-life statement for the packaging.
Last updated: September 2026
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