PPE-Info - Standard Details

Association for the Advancement of Medical Instrumentation (AAMI)

Title

"Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities"

Description

Overview: This standard establishes a system of classification for protective apparel and drapes used in health care facilities based on their liquid barrier performance and specifies related labeling requirements and standardized test methods for determining compliance.

Standard Type(s)

Specification

An explicit set of requirements to be satisfied by a material, product, system, or service: Examples of specifications include, but are not limited to, requirements for; physical, mechanical, or chemical properties, and safety, quality, or performance criteria. A specification identifies the test methods for determining whether each of the requirements is satisfied.

Personal Protective Equipment

Body Protection

All items of clothing and/or accessories (whether or not detachable) designed and manufactured to provide specific protection. This includes bullet-proof clothing, general protective clothing and full body ensembles that protect from cuts, radiation, temperature extremes, hot splashes from molten metals and other hot liquids, potential impacts from tools, machinery and materials and hazardous chemicals. Examples of body protection include laboratory coats, coveralls, vests, jackets, aprons, surgical gowns and full body suits

Medical protective clothing
Coveralls
Apron
Gowns
Drapes

Hazards

Biological

Biological

Comments

The ANSI/AAMI PB70 standard includes four standard tests to evaluate the barrier effectiveness of surgical gowns, isolation gowns, and surgical drapes. Based on the results of these standardized tests, four levels of barrier performance are defined, with Level 1 being the lowest level of protection, and Level 4 being the highest level of protection. Table 3 summarizes the requirements of ANSI/AAMI PB70:2012 regarding the classification of barrier performance of surgical gowns, isolation gowns, and surgical drapes.

Table 3: ANSI/AAMI PB 70:12 classification of barrier performance of surgical gowns, other protective apparel, surgical drapes and drape accessories

Level1

Level¹	Test	Liquid Challenge	Result	Expected Barrier Effectiveness
1	AATCC 42 Impact Penetration²	Water	= 4.5 g	Minimal water resistance (some resistance to water spray)
2	AATCC 42 Impact Penetration	Water	= 1.0 g	Low water resistance (resistant to water spray and some resistance to water penetration under constant contact with increasing pressure)
2	AATCC 127 Hydrostatic Pressure³	Water	= 20 cm
3	AATCC 42 Impact Penetration	Water	= 1.0 g	Moderate water resistance (resistant to water spray and some resistance to water penetration under constant contact with increasing pressure)
3	AATCC 127 Hydrostatic Pressure	Water	= 50 cm
4	ASTM F1670 Synthetic Blood Penetration Test (for surgical drapes)	Surrogate Blood	no penetration at 2 psi(13.8 kPa)	Blood and viral penetration resistance (2 psi)
4	ASTM F1671 Viral Penetration Test (for surgical and isolation gowns)	Bacteriophage Phi-X174	no penetration at 2 psi(13.8 kPa)	Blood and viral penetration resistance (2 psi)
¹ In order of increasing protection ² American Association of Textile Chemists and Colorists (AATCC) 42 Water resistance: impact penetration test determines the ability of a material to resist water penetration under spray impact [AATCC 2000] ³ AATCC 127 Water resistance: hydrostatic pressure test determines the ability of a material to resist water penetration under constant contact with increasing pressure [AATCC 1998]

As indicated in Table 3, the requirements for levels 1, 2, and 3 have specific test requirements associated with them. Only Level 4 gowns are tested for viral penetration resistance, and therefore only Level 4 garments are considered impermeable to viral penetration using ASTM F1671. The gowns complying with the lower levels (Level 1, 2, and 3) cannot be considered impermeable. However, Level 1–3 gowns can provide increasing resistance to liquids. ANSI/AAMI PB70 Level 1, 2, and 3 surgical/isolation gown-testing requirements only use water as a challenge. Because the surface tension of water is much higher than that of blood, blood can penetrate through fabrics more readily than water. Therefore, no correlation can be made between AATCC water resistance tests (AATCC 42 and AATCC 127) and ASTM F1671 viral penetration tests, and consequently, protection provided by Levels 1, 2, 3 gowns and that of Level 4 gowns. A common misunderstanding among many end-users is that they are protected from blood, body fluids, and other potentially infectious materials (OPIM) when they wear any type of fluid-resistant garment or surgical or isolation gown.

Testing Laboratories

Intertek - Cortland, NY, 13045

Contact

Phone Number: (607) 753-6711
Email: jason.allen@intertek.com

Accreditations

ISO 17025

Scope of Accreditation

ANSI/ISEA Z87.1-2020 , ASTM F2412 - 18a , ASTM D120 - 22 , ASTM D3577 - 19(2023) , ASTM D3578 - 19(2023) , ASTM D5250 - 19(2023) , ASTM D5712 - 15(2020) , ASTM D6319 - 19(2023) , ASTM D6978 - 05(2023) , ASTM D7246 - 06(2021) , ASTM F1446 - 20 , ANSI/AAMI PB70:2022 , ASTM F1342 / F1342M - 05(2022) , ASTM F1359 / F1359M - 22 , ASTM F1670 / F1670M - 17a , ASTM F1671 / F1671M - 22 , ASTM F1790 / F1790M - 15 (Reapproved 2021) , ASTM F2588 - 12(2020) , ASTM F739 - 20 , ASTM F903 - 18 , ASTM F1862 / F1862M - 17 , ASTM F2100 - 23 , ASTM F2101 - 23 , ASTM F2299 / F2299M - 24 , ANSI/AAMI PB70 - Class 4 , ANSI/AAMI PB70 - Class 3

Akron Rubber Development Laboratory, Inc. - Akron, OH, 44322-1016

Notes

Accredited Gloves Testing Methods ASTM Testing Methods

ASTM D6319 - Standard Specification for Nitrile Examination Gloves for Medical Application
ASTM D6978 - Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
ASTM D7558 - Colorimetric/Spectrophotometric Procedure to Quantify Extractable Chemical Dialkyldithiocarbamate, Thiuram and Mercaptobenzothiazole Accelerators in Natural Rubber Latex and Nitrile Gloves
ASTM D120 — Standard Specification for Rubber Insulating Gloves
ASTM D3577 — Standard Specification for Rubber Surgical Gloves
ASTM D3578 — Standard Specification for Rubber Examination Gloves
ASTM D5151 — Standard Test Method for Detection of Holes in Medical Gloves
ASTM D6124 — Standard Test Method for Residual Powder on Medical Gloves
ASTM D5250 - Standard Specification for Poly (Vinyl Chloride) Gloves for Medical Application
ARDL 2140 - Lubricant Compatibility Testing on Gloves
ASTM D5712 - Analysis of Aqueous Extractable Protein in Latex, Natural Robber and Elastomeric Products Using the Modified Lowry Method
ASTM D6499 - Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products
ASTM F739 — Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact
ASTM F1383 - Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Intermittent Contact
ASTM F1670 - Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
ASTM F1671/F1671M — 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 F903 — Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Liquids
ASTM E96/E96M Water Vapor Transmission of Materials
ASTM D6977 — Standard Specification for Polychloroprene Examination Gloves for medical Application
ASTM D7246 — Standard Test Method for Detection of Holes in Polyethylene Food Service Gloves
ASTM D7329 — Standard Specification for Food Preparation and Food Handling Glove