AAMI level gowns are disposable protective garments rated under ANSI/AAMI PB70, a standard that sorts barrier performance into four levels. Level 1 is minimal protection for basic care, Level 2 covers low-risk fluid exposure, Level 3 handles moderate exposure such as irrigation, and Level 4 adds resistance to blood-borne pathogen penetration. For a Canadian clinic the level you buy should follow the task, not the price list.
Quick facts
- ANSI/AAMI PB70 defines four barrier performance levels for protective gowns.
- Levels 1 to 3 rely on AATCC 42 spray and AATCC 127 hydrostatic pressure testing.
- Level 4 adds ASTM F1671 resistance to blood-borne pathogen penetration.
- ASTM F2407 is the surgical gown specification and it references the PB70 levels.
- AAMI 11135 is an ethylene oxide sterilization standard, not a gown rating.
The Four PB70 Levels and the Tests Behind Them
PB70 does not assess gowns on people; it tests fabric and seam performance in a laboratory. Levels 1 to 3 use two measures: AATCC 42, a water spray test that records how much liquid passes through, and AATCC 127, a hydrostatic pressure test that records how much water pressure the fabric resists. Level 4 adds ASTM F1671, which challenges the material with a bacteriophage to model penetration by blood-borne pathogens.
| Level | Barrier performance | Key test criteria | Typical Canadian use |
|---|---|---|---|
| Level 1 | Minimal | AATCC 42 spray test | Basic care, visitors, low fluid contact |
| Level 2 | Low | AATCC 42 plus AATCC 127 hydrostatic pressure | Isolation rooms, routine clinical care |
| Level 3 | Moderate | AATCC 42 plus a higher AATCC 127 pressure | Irrigation, arterial draws, longer procedures |
| Level 4 | High | ASTM F1671 viral penetration resistance | Surgery and high-fluid, blood-borne risk |
aami level gowns
Buyers searching that phrase usually want a plain answer: AAMI level gowns are the four PB70 classes above, and a compliant label should state the level, the standard it was tested to and the single-use status. If a supplier quotes a level without naming PB70 or the test methods, ask for the documentation before you order.
PB70, ASTM F2407 and AAMI 11135 Are Three Different Things
These three standards get mixed up constantly in purchasing conversations. PB70 sets the barrier levels. ASTM F2407 is the specification for surgical gowns, and it references the PB70 levels while adding physical performance such as tensile strength, tear resistance and seam strength, plus linting and flammability criteria. AAMI 11135 sits in a completely different lane.
aami 111352014 what does that mean and is it aami level 3
Short answer: no. AAMI 11135:2014 is the standard for ethylene oxide sterilization of health care products. It governs how a sterilizing process is validated and controlled, not how a garment resists fluid. It has nothing to do with gown protection levels. If a specification sheet lists AAMI 11135 beside a gown, that line is a sterilization reference, not a barrier rating, and you should still ask which PB70 level the gown meets.
How to Choose a Level for Your Care Setting
Match the level to the fluid risk of the task. In a dental or family practice, Level 1 gowns suit front-desk and low-contact care, while Level 2 covers routine clinical work where splashes are possible. Long-term care and isolation rooms generally sit at Level 2. Procedures with irrigation, arterial blood draws or extended fluid exposure call for Level 3, and surgical or high-fluid environments need Level 4 with its ASTM F1671 claim.
Isolation gowns are usually specified under PB70 alone, while surgical gowns add ASTM F2407 to cover strength and durability. A 40 gsm Level 2 SMS isolation gown in a 50-pack fits most Canadian clinical and long-term care settings, and a non-woven Level 1 fluid-resistant gown covers lower-risk contact and visitor use.
Cost and supply planning for gowns is covered in our PPE price, MOQ and lead-time benchmarks and in the note on gown consumable planning for ophthalmic day surgery.
Buying, Labelling and Documentation
Ask for the level, the standard and the test report, and keep the documentation with the purchase record so an inspection is a lookup rather than a hunt. The wider buying picture, including standards referenced in our comparison of ASTM F2407 and AAMI PB70 for buyers, sits alongside the compliance material on the sterilization and compliance hub. Clinics reviewing their PPE and monitoring lines together can also start with a 5-pack biological indicator trial.
Ordering for a clinic, lab or care home? Wholesale and multi-site ordering covers case pricing and account setup, and the B2B wholesale collection lists the lines stocked for institutional buyers.
Related reading
- Isolation gown standards: ASTM F2407 and AAMI PB70 compared
- PPE supplier price, MOQ and lead-time benchmarks in Canada
- Sterilization and compliance hub for Canadian clinics
- clinic consumables
- sterilization record-keeping tool
Frequently Asked Questions
What is the difference between AAMI Level 1 and Level 4 gowns?
Level 1 is minimal barrier protection for low fluid contact, tested with AATCC 42. Level 4 is the highest level and adds ASTM F1671 viral penetration resistance for surgical and high-fluid environments.
Does a Level 2 gown protect against blood-borne pathogens?
Level 2 covers low-risk fluid exposure and resists water spray and modest hydrostatic pressure. Resistance to blood-borne pathogen penetration is the ASTM F1671 claim that defines Level 4, so a task with that risk needs Level 4.
What is ASTM F2407 and how does it relate to AAMI PB70?
ASTM F2407 is the specification for surgical gowns. It references the PB70 barrier levels and adds physical performance such as tensile and tear strength, seam strength, linting and flammability.
Which gown level should a Canadian clinic buy?
Match the level to the task. Level 1 fits low-contact care and visitors, Level 2 covers routine clinical and long-term care, Level 3 handles irrigation and longer fluid exposure, and Level 4 suits surgery.
Is AAMI 11135 the same as a gown protection level?
No. AAMI 11135:2014 is the ethylene oxide sterilization standard. It governs a sterilizing process, not garment barrier performance, so it says nothing about whether a gown is Level 1, 2, 3 or 4.
CliniEco Medical is a licensed medical device establishment (MDEL #35334).
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