What's the Difference Between AAMI Levels in Surgical and Isolation Gowns?

As COVID-19 pandemic has spread across the globe, Personal Protective Equipment (PPE) has become some of the highest demand items in the world. As many new suppliers emerged, many are faced with the challenges of identifying the appropriate levels of protection and standards of PPE that they need. What are the differences in the different AAMI levels available?


N Medical team with over 80 years of experience in the field of manufacturing and distribution of medical supplies intends to help answer some of the basic questions about the different stands for gowns that has AAMI ratings.


ANSI/AAMI PB70:2012 Level 1:

  • Minimal Fluid Barrier Protection – water impact test less than 4.5g. Tested by AATCC42 with water

  • Suitable for daily patient care with little to no risk of fluid exposure. Generally not suitable for use in the OR

ANSI/AAMI PB70:2012 Level 2:

  • Low level of fluid barrier protection – spray impact test less than 1.0g, hydrostatic pressure test greater than 20cm. Tested by AATCC42 and AATCC127 with water

  • Suitable for slight risk of fluid exposure and minimally invasive surgical procedures

ANSI/AAMI PB70:2012 Level 3:

  • Moderate level of fluid barrier protection – spray impact test less than 1.0g, hydrostatic pressure test greater than 50cm. Tested by AATCC42 and AATCC127 with water

  • Suitable for slight risk of fluid exposure and minimally invasive surgical procedures

  • Typically used as a surgical gown with EO sterilised package

ANSI/AAMI PB70:2012 Level 4:

  • High level of fluid barrier protection that provides protection against blood borne pathogens in critical zones. Tested by ASTM F1671 Viral Penetration Test (for surgical and isolation gowns) with Bacteriophage Phi-X174. Blood and viral penetration resistance (2 psi)

  • Suitable for high risk of fluid exposure and virus penetration for up to 1 hour

  • Typically used as a surgical gown with EO sterilised package

There are other isolations gowns that offer fluid protection but are not necessarily rated by AAMI due to construction features of the gowns, such as having an open back design and/or sewn seams.


Any isolation gown that carries an AAMI Level 3 or 4 are typically Class II medical devices are may require special registration in certain countries. For example, in the USA AAMI Level 3 or 4 gowns are considered Class II medical devices and would have to be registered with the US FDA along with premarket notification approval.


N Medical team has deep experience in the manufacturing of isolation gowns and surgical gowns. We designed the perfect balance between comfort and safety for medical professionals. We did not choose to use the thickest materials because it is unnecessarily thick and uncomfortable. We also did not choose shortcuts by using PE coating for all of our gowns. Instead, we picked the balance between the most protective materials and comfort that meets international standards. Here is our current line up for isolation gowns and surgical gowns.


N Medical offers a wide range of gowns that can be produced from AAMI Level 1-4. Please consult one of our experts to learn more about our product range. Learn more about our personal protective equipment PPE here:

https://www.nmedicalsupplies.com/product-type/ppe



N Medical Disposable SMMS Isolation Gown
N Medical Disposable SMMS Isolation Gown

Definitions of AATC42, AATC127, ASTM F1670-17, and ASTM F1671-13 tests:

  • AATCC 42-2017: Measures resistance of fabrics to the penetration of water by impact (AATCC, 2018)

  • AATCC 127-2017: Measures resistance of fabric to the penetration of water under hydrostatic pressure (AATCC, 2017)

  • ASTM F1670-17: Evaluate resistance of materials used in protective clothing to penetration by synthetic blood under conditions of continuous liquid contact (ASTM, 2017)

  • ASTM F1671-13: Measure penetration by blood-borne pathogens using a surrogate microbe under conditions of continuous liquid contact (ASTM, 2013)

Reference:

1. Pfiedler Enterprises 2016, AAMI Levels and Surgical Gowns: Know if You’re Protected, viewed 17 July 2018, <http://www.pfiedler.com/ce/1191/files/assets/common/downloads/AAMI%20Levels%20and%20Surgical%20Gowns.pdf>

2. AATCC TM42-2017, Water Resistance: Impact Penetration Test, American Association of Textile Chemists and Colorists, RTP, NC, USA, 2018, <https://www.aatcc.org/>

3. AATCC TM127-2017, Water Resistance: Hydrostatic Pressure Test, American Association of Textile Chemists and Colorists, RTP, NC, USA, 2017, <https://www.aatcc.org/>

4. ASTM F1670 / F1670M-17a, Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood, ASTM International, West Conshohocken, PA, 2017, <https://www.astm.org>

5. ASTM F1671 / F1671M-13, Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System, ASTM International, West Conshohocken, PA, 2013, https://www.astm.org

6. Sections 3.13 and 3.31 of the ANSI/AAMI PB 70:2012 (citing 21 CFR 878.4040).

7. https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gowns#g4

8. Guidance document on Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings


Disclaimer: The information on this website is intended for health care professionals only. Article information are for educational purposes only, please consult your local medical professionals for the most accurate and updated information. Product information is for educational purposes only, and not all products or indications are licensed in every country.

N Medical is an international healthcare wholesale supplier that aims to deliver the best medical products and services to every end user in the world. The company is currently managed by a team with over 80 years of experience in the healthcare industry, engaged in the design, development, manufacturing, distribution, sales, and marketing of top quality medical supplies, medical device, and medical equipment. Our products are currently being used by various end-users in public and private sectors. Since the brand's inception in 2015, we have already been established to become one of the leading medical supplies companies in Asia with presence in Melbourne Australia, Hong Kong and Macau China.

Notably, N Medical became one of the primary suppliers for medical products in Hong Kong and Macau, supplying to all the public and private hospitals, government entities, and clinics. During COVID-19, we supported the local governments in their efforts to combat the virus with various personal protective equipment (PPE) and facilitated local vaccination programs to over 8 million end users with various medical products.

N Medical currently produces over 100 types of products, including personal protective equipment, surgical consumables products, wound treatment products, gauze and swabs, bandages, tapes, dressing, dental supplies, sterilisation and disposable products, surgical apparel, first aid kit components, alcohol pad and wipes, medical gloves, gowns, face masks, adhesives and sealants for wound dressing, and cream and ointment.

N Medical was founded in 2015 with the goal of developing the finest medical supplies and equipment that can meet multiple international standards and medical needs. The company was started by a team from one of the most well established medical supplies, medical equipment, and pharmaceutical supplies distributor with over 80 years of experience. The team had years of experience working with the largest and most established pharmaceutical companies and medical supplies brands from USA, UK, Australia, and EU. The team has deep professional knowledge of developing medical products, including manufacturing, quality control, international certification, and tender documentation for the end users in the medical field.

Currently, our team maintains control over the manufacturing of products, ensuring all products comply with stringent quality standards. We are devoted to sourcing the highest quality raw material with the best manufacturing processes. Our multinational manufacturing capabilities and strict quality control measures ensure our products maintain consistent quality.