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ANSI/AAMI PB70 - Class 4
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
SOC Codes
29-0000 Healthcare Practitioners and Technical Occupations
  • 29-1000 Health Diagnosing and Treating Practitioners
    • 29-1063 Physicians, Internal Medicine
    • 29-1069 Physicians and Surgeons, All Other
    • 29-1140 Registered Nurses
Comments

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)
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)
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)
ASTM F1671 Viral Penetration Test (for surgical and isolation gowns) Bacteriophage
Phi-X174		 no penetration at 2 psi(13.8 kPa)

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]

 

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(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/ISEAZ8712020) , ASTM F2412 - 18a(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF241218a) , ASTM D120 - 22(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD12022) , ASTM D3577 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD357719(2023)) , ASTM D3578 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD357819(2023)) , ASTM D5250 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD525019(2023)) , ASTM D5712 - 15(2020)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD571215(2020)) , ASTM D6319 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD631919(2023)) , ASTM D6978 - 05(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD697805(2023)) , ASTM D7246 - 06(2021)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD724606(2021)) , ASTM F1446 - 20(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF144620) , ANSI/AAMI PB70:2022(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70%3a2022) , ASTM F1342 / F1342M - 05(2022)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1342/F1342M05(2022)) , ASTM F1359 / F1359M - 22(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1359/F1359M22) , ASTM F1670 / F1670M - 17a(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1670/F1670M17a) , ASTM F1671 / F1671M - 22(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1671/F1671M22) , ASTM F1790 / F1790M - 15 (Reapproved 2021)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1790/F1790M15(Reapproved2021)) , ASTM F2588 - 12(2020)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF258812(2020)) , ASTM F739 - 20(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF73920) , ASTM F903 - 18(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF90318) , ASTM F1862 / F1862M - 17(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1862/F1862M17) , ASTM F2100 - 23(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF210023) , ASTM F2101 - 23(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF210123) , ASTM F2299 / F2299M - 24(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF2299/F2299M24) , ANSI/AAMI PB70 - Class 4(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70Class4) , ANSI/AAMI PB70 - Class 3(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70Class3)

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

The following link points to ARDL's searchable ISO 17025 Scope of Accreditations: 

https://www.ardl.com/sites/default/files/assets/scope-as-of-8-30-22.pdf
Contact

Phone Number: (330) 794-6600
Email: answers@ardl.com

Accreditations

ISO 17025

Scope of Accreditation

ASTM D120 - 22(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD12022) , ASTM D3577 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD357719(2023)) , ASTM D3578 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD357819(2023)) , ASTM D5151 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD515119(2023)) , ASTM D5250 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD525019(2023)) , ASTM D5712 - 15(2020)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD571215(2020)) , ASTM D6124 - 06(2022)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD612406(2022)) , ASTM D6319 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD631919(2023)) , ASTM D6978 - 05(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD697805(2023)) , ASTM D7246 - 06(2021)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD724606(2021)) , ANSI/AAMI PB70:2022(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70%3a2022) , ASTM F1342 / F1342M - 05(2022)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1342/F1342M05(2022)) , ASTM F1383 - 20(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF138320) , ASTM F1670 / F1670M - 17a(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1670/F1670M17a) , ASTM F1671 / F1671M - 22(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1671/F1671M22) , ASTM F739 - 20(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF73920) , ASTM F903 - 18(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF90318) , ANSI/AAMI PB70 - Class 4(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70Class4) , ANSI/AAMI PB70 - Class 3(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70Class3)

Nelson Laboratories, Inc. - Salt Lake City, UT, 84123
Notes

FDA Registered and ANSI-ASQ National Accreditation Board/ACLASS
Contact

Phone Number: (801) 290-7500
Email: sdrosner@nelsonlabs.com

Accreditations

ISO 17025

Scope of Accreditation

ASTM D120 - 22(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD12022) , ASTM D3577 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD357719(2023)) , ASTM D3578 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD357819(2023)) , ASTM D5151 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD515119(2023)) , ASTM D5250 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD525019(2023)) , ASTM D5712 - 15(2020)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD571215(2020)) , ASTM D6124 - 06(2022)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD612406(2022)) , ASTM D6319 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD631919(2023)) , ASTM D6978 - 05(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD697805(2023)) , ASTM D7246 - 06(2021)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD724606(2021)) , ANSI/AAMI PB70:2022(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70%3a2022) , ASTM F1342 / F1342M - 05(2022)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1342/F1342M05(2022)) , ASTM F1670 / F1670M - 17a(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1670/F1670M17a) , ASTM F1671 / F1671M - 22(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1671/F1671M22) , ASTM F903 - 18(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF90318) , ASTM F1862 / F1862M - 17(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1862/F1862M17) , ASTM F2100 - 23(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF210023) , ASTM F2101 - 23(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF210123) , ASTM F1819 - 19(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF181919) , ANSI/AAMI PB70 - Class 4(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70Class4) , ANSI/AAMI PB70 - Class 3(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70Class3)

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