PPE-Info - Standard Details

ASTM International (ASTM)

Title

"Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood"

Description

This test method is used to evaluate the resistance of materials used in protective clothing to penetration by synthetic blood under conditions of continuous liquid contact. Protective clothing pass/fail determinations are based on visual detection of synthetic blood penetration.

Standard Type(s)

Test Method

A definitive procedure that produces a test result: Examples of test methods include, but are not limited to: identification, measurement, and evaluation of one or more qualities, characteristics, or properties. A precision and bias statement shall be reported at the end of a test method.

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

Hazards

Biological

Biological

SOC Codes

29-0000 Healthcare Practitioners and Technical Occupations

29-1000 Health Diagnosing and Treating Practitioners
- 29-1011 Physicians, Chiropractic
- 29-1141 Registered Nurses
- 29-1190 Health Diagnosing and Treating Practitioners, Miscellaneous

Standard References

Referenced Standard

ASTM F1671 / F1671M - 22 - 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 - 18 - Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Liquids

29 CFR 1910.1030 - Bloodborne pathogens

Conformity Assessment Notes

This test method is based on Test Method F903 for measuring resistance of chemical protective clothing materials to penetration by liquids. This test method is normally used to evaluate specimens from individual finished items of protective clothing and individual samples of materials that are candidates for items of protective clothing. Please see the full standard for complete details.

Comments

ASTM F1670 and ISO 16603 are “screening-tests” that evaluate the resistance of a material to synthetic blood penetration [ASTM 2003a; ISO 2004a]. The synthetic blood used for these tests is a mixture of cellulose, coloring, buffer solution, and stabilizing agents. Synthetic blood has a surface tension (0.042 ± 0.002 Newton per meter [N/m]) and viscosity representative of blood and some body fluids (see Table 2 for surface tension of the body fluids).

Within the context of gowns and coverall testing, the surface tension of the challenge liquid is critical. This is because liquids with higher surface tension, like water (0.070–0.072 N/m), are more likely to bead on a surface than liquids with lower surface tension, which are more likely to wet and penetrate through the garment. Consequently, some test methods that use water as a challenge agent may not be representative for evaluating the barrier effectiveness of the healthcare PPE and may overestimate the effectiveness of the PPE for blood-borne pathogens. Test methods evaluating the water resistance of garments will be discussed later in this document.

Additional References:

ASTM Standards

D1331 Test Methods for Surface and Interfacial Tension of Solutions of Surface-Active Agents
D1777 Test Method for Thickness of Textile Materials
D3776 Test Methods for Mass Per Unit Area (Weight) of Fabric
E105 Practice for Probability Sampling of Materials
E171 Practice for Conditioning and Testing Flexible Barrier Packaging
F903 Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Liquids
F1671 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

Military Standard

MIL-STD-105 Sampling Procedures and Tables for Inspection by Attributes

ANSI/ASQC Standards

ANSI/ASQC Z1.4 Sampling Procedures and Tables for Inspection by Attributes

ISO Standard

ISO 2859-1 Sampling Plans for Inspection by Attributes

OSHA Standard

29 CFR Part 1910.1030 Occupational Exposure to Bloodborne Pathogens: Final Rule, Federal Register, Vol 56, No 235, Dec. 6, 1991, pp. 6175–64182.

Testing Laboratories

ICS Laboratories, Inc - Brunswic, OH, 44212

Notes

A2LA ISO/IEC 17025

Contact

Phone Number: (330) 220-0515
Email: spfriem@icslabs.com

Accreditations

ISO 17025

Scope of Accreditation

ANSI/ISEA Z87.1-2020 , ASTM D120 - 22 , ASTM D5250 - 19(2023) , ASTM D6978 - 05(2023) , ASTM D7246 - 06(2021) , ASTM F1446 - 20 , ASTM F1383 - 20 , ASTM F1407 - 12(2017) , ASTM F1670 / F1670M - 17a , ASTM F1671 / F1671M - 22 , ASTM F739 - 20 , ASTM F903 - 18

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