ASTM F1819-19

Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood Using a Mechanical Pressure Technique

SIGNIFICANCE AND USE
5.1 This test method was modeled after a procedure commonly known as the Elbow Lean Test.8 The Elbow Lean Test involves the application of synthetic blood to an ink pad, placement of sample fabric over the blood-soaked pad, placement of a blotter over the sample fabric, and applying elbow or fingertip pressure on top of the blotter. The blotter is then examined for staining as evidence of blood penetration. This test method provides similar procedures which standardize the test equipment and application of pressure through an adopted methodology.  
5.2 This test method is intended to simulate actual use conditions wherein areas of the healthcare worker's protective clothing are soaked with blood and compressed between the patient's body and that of the healthcare worker, or similarly between the healthcare worker and instruments. In both cases, unconfined blood can move away from the pressure point taking the path of least resistance rather than being contained as in Test Methods F1670/F1670M and F1671/F1671M.  
5.3 This test method uses predominately mechanical pressure as opposed to contained, hydrostatic pressure to demonstrate liquid penetration resistance (1, 2) . It simulates a single insult in which the outer surfaces of a protective clothing item are compressed at a steady rate by the wearer's body against a wet surface. This steady rate of compression represents one potential use scenario. Other scenarios may result in a wide variety of pressure ramp rates and profiles that are not simulated by the test apparatus.  
5.4 Because this test method provides quantitative results, it is useful for discriminating differences in the liquid barrier performance of protective clothing materials. This test method can be used for measuring differences in the penetration pressure for protective clothing materials which do not pass Test Method F1670/F1670M.  
5.5 This test method is normally used to evaluate specimens from individual finished items of protective cloth...
SCOPE
1.1 This test method is used to evaluate the resistance of materials used in protective clothing to synthetic blood under the conditions of liquid contact and increasing direct mechanical pressure. The penetration resistance of protective clothing is based on visual detection of synthetic blood penetration at a specific applied mechanical pressure.  
1.2 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method must review modes for work/clothing exposure and assess the appropriateness of this test method for their specific application.  
1.3 This test method addresses only the performance of materials or certain material constructions (for example, seams) used in protective clothing. This test method does not address the design, overall construction, components, or interfaces of garments, or other factors which may affect the overall protection offered by the protective clothing.  
1.4 The values in SI units or in other units shall be regarded separately as standard. The values stated in each system must be used independently of the other, without combining values in any way.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

• Status: Published
• Publication Date: 30-Apr-2019
• ICS: 11.140 - Hospital equipment
• ICS: 13.340.10 - Protective clothing
• Technical Committee: F23 - Personal Protective Clothing and Equipment
• Drafting Committee: F23.40 - Biological

Relations

• Replaces: ASTM F1819-07(2013) - Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood Using a Mechanical Pressure Technique
• Effective Date: 01-May-2019
• Refers: ASTM F1670/F1670M-24 - Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
• Effective Date: 01-Feb-2024
• Refers: ASTM E171/E171M-11(2020) - Standard Practice for Conditioning and Testing Flexible Barrier Packaging
• Effective Date: 01-May-2020
• Refers: ASTM D1777-96(2019) - Standard Test Method for Thickness of Textile Materials
• Effective Date: 01-Jul-2019
• Refers: ASTM F1670/F1670M-17a - Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
• Effective Date: 25-Oct-2017
• Refers: ASTM D3776/D3776M-09a(2017) - Standard Test Methods for Mass Per Unit Area (Weight) of Fabric
• Effective Date: 15-Jul-2017
• Refers: ASTM F1670/F1670M-17 - Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
• Effective Date: 01-Jul-2017
• Refers: ASTM E171/E171M-11(2015) - Standard Practice for Conditioning and Testing Flexible Barrier Packaging
• Effective Date: 01-Oct-2015
• Refers: ASTM D1777-96(2015) - Standard Test Method for Thickness of Textile Materials
• Effective Date: 01-Jul-2015
• Refers: ASTM F1670/F1670M-08(2014)e1 - Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
• Effective Date: 15-Jun-2014
• Refers: ASTM D3776/D3776M-09a(2013) - Standard Test Methods for Mass Per Unit Area (Weight) of Fabric
• Effective Date: 01-Jul-2013
• Refers: ASTM F1494-13 - Standard Terminology Relating to Protective Clothing
• Effective Date: 01-Jul-2013
• Refers: ASTM E691-13 - Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
• Effective Date: 01-May-2013
• Refers: ASTM E171/E171M-11 - Standard Practice for Conditioning and Testing Flexible Barrier Packaging
• Effective Date: 15-Nov-2011
• Refers: ASTM E691-11 - Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
• Effective Date: 01-Nov-2011

Overview

ASTM F1819-19 specifies the Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood Using a Mechanical Pressure Technique. Developed by ASTM International, this test method is vital for assessing the barrier effectiveness of protective clothing materials, particularly for workers in healthcare and laboratory settings who may be exposed to blood-borne pathogens. By simulating real-world scenarios where protective garments come in contact with and are subjected to pressure from synthetic blood, this standard helps manufacturers and users evaluate the resistance of protective clothing materials against liquid penetration under mechanical pressure.

Key Topics

• Mechanical Pressure Simulation: The test involves applying synthetic blood to a sample fabric and then applying gradually increasing mechanical pressure until penetration occurs or a specified maximum pressure is reached.
• Visual Detection: Resistance to penetration is determined visually, providing a clear criterion for pass/fail based on the presence or absence of synthetic blood on the non-contact side of the material.
• Focus on Material Performance: The standard assesses only the barrier properties of the clothing material or seams, not the overall garment design or assembly.
• Relevance to Actual Use Conditions: Unlike tests that use hydrostatic pressure, this method better simulates scenarios common in healthcare environments, such as compression of clothing between the worker and patient or instrument.
• Quantitative and Comparative Results: The method yields quantitative data on penetration pressure, facilitating comparison between different materials or samples, and can serve as a tool for quality control and assurance.

Applications

• Healthcare Protective Clothing Assessment: Used by manufacturers and regulatory agencies to evaluate gloves, gowns, aprons, hoods, boots, arm shields, and other items intended to protect wearers from exposure to blood and potential blood-borne pathogens.
• Material Qualification and Selection: Enables the screening and selection of fabrics for personal protective equipment (PPE) based on their resistance to synthetic blood penetration under realistic conditions.
• Quality Assurance Programs: Provides a standardized approach for ongoing quality control, ensuring finished protective clothing items meet the required resistance specifications before distribution or use.
• Comparative Product Evaluation: Assists healthcare organizations, procurement teams, and research laboratories in comparing the protective performance of various PPE products and materials.
• Research and Development: Supports the development and validation of new protective materials and technologies intended to improve healthcare and laboratory safety.

Related Standards

• ASTM F1670 / F1670M: Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood (hydrostatic pressure technique).
• ASTM F1671 / F1671M: Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration.
• ASTM D1331: Test Methods for Surface and Interfacial Tension of Solutions.
• ASTM D1777: Test Method for Thickness of Textile Materials.
• ASTM D3776 / D3776M: Test Methods for Mass Per Unit Area (Weight) of Fabric.
• ASTM E171 / E171M: Practice for Conditioning and Testing Flexible Barrier Packaging.
• ASTM F1494: Terminology Relating to Protective Clothing.
• ISO 2859-1: Sampling Plans for Inspection by Attributes.
• ANSI/ASQC Z1.4: Sampling Procedures and Tables for Inspection by Attributes.
• OSHA 29 CFR Part 1910.1030: Occupational Exposure to Blood-Borne Pathogens.

Practical Value

Implementing ASTM F1819-19 supports compliance with regulatory and industry requirements for protective clothing in healthcare and laboratory environments. It ensures products offer consistent and reliable protection against liquid penetration under mechanical stress, helping to safeguard workers from blood-borne infectious agents. The method’s focus on realistic exposure scenarios and quantitative results makes it an essential tool for material selection, quality control, and ongoing product improvement in the protective clothing industry.

Keywords: ASTM F1819, synthetic blood penetration, protective clothing, blood-borne pathogen protection, mechanical pressure, PPE testing, barrier performance, healthcare worker safety, penetration resistance.

Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F1819 − 19
Standard Test Method for
Resistance of Materials Used in Protective Clothing to
Penetration by Synthetic Blood Using a Mechanical
Pressure Technique
This standard is issued under the fixed designation F1819; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
Workers,primarilythoseinthehealthcareprofession,involvedintreatingandcaringforindividuals
injured or sick, can be exposed to biological liquids capable of transmitting disease. These diseases,
whichmaybecausedbyavarietyofmicroorganisms,canposesignificantriskstolifeandhealth.This
isespeciallytrueofblood-borneviruseswhichcauseHepatitis(HepatitisBVirus(HBV)andHepatitis
C Virus (HCV)) and acquired immune deficiency syndrome (AIDS) (human immunodeficiency
viruses (HIV)). Since engineering controls cannot eliminate all possible exposures, attention is placed
on reducing the potential for direct skin contact through the use of protective clothing that resists
penetration (29 CFR Part 1910.1030).This test method was developed to help assess the effectiveness
of materials used in protective clothing for protecting the wearer against contact with body fluids that
potentially contain blood-borne pathogens. Using synthetic blood, this test method is intended to
determine the amount of mechanical pressure that will cause penetration of a liquid through a material
used in protective clothing.
1. Scope 1.4 The values in SI units or in other units shall be regarded
separately as standard. The values stated in each system must
1.1 This test method is used to evaluate the resistance of
be used independently of the other, without combining values
materials used in protective clothing to synthetic blood under
in any way.
the conditions of liquid contact and increasing direct mechani-
1.5 This standard does not purport to address all of the
cal pressure. The penetration resistance of protective clothing
safety concerns, if any, associated with its use. It is the
is based on visual detection of synthetic blood penetration at a
responsibility of the user of this standard to establish appro-
specific applied mechanical pressure.
priate safety, health, and environmental practices and deter-
1.2 This test method does not apply to all forms or condi-
mine the applicability of regulatory limitations prior to use.
tions of blood-borne pathogen exposure. Users of the test
1.6 This international standard was developed in accor-
method must review modes for work/clothing exposure and
dance with internationally recognized principles on standard-
assess the appropriateness of this test method for their specific
ization established in the Decision on Principles for the
application.
Development of International Standards, Guides and Recom-
1.3 This test method addresses only the performance of mendations issued by the World Trade Organization Technical
materials or certain material constructions (for example, Barriers to Trade (TBT) Committee.
seams) used in protective clothing. This test method does not
2. Referenced Documents
address the design, overall construction, components, or inter-
facesofgarments, orotherfactorswhichmayaffectthe overall
2.1 ASTM Standards:
protection offered by the protective clothing.
D1331 Test Methods for Surface and Interfacial Tension of
Solutions of Paints, Solvents, Solutions of Surface-Active
Agents, and Related Materials
ThistestmethodisunderthejurisdictionofASTMCommitteeF23onPersonal
Protective Clothing and Equipment and is the direct responsibility of Subcommittee
F23.40 on Biological. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved May 1, 2019. Published May 2019. Originally contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
approved in 1997. Last previous edition approved in 2013 as F1819 – 07 (2013). Standards volume information, refer to the standard’s Document Summary page on
DOI: 10.1520/F1819-19. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1819 − 19
D1777 Test Method for Thickness of Textile Materials 3.1.4 hydrostatic pressure, n—the force exerted by a static
D3776/D3776M Test Methods for Mass Per Unit Area liquid (1).
(Weight) of Fabric
3.1.5 mechanical pressure, n—the force exerted by one
E105 Practice for Probability Sampling of Materials
solid object upon another that it is touching (1).
E171/E171M Practice for Conditioning and Testing Flexible
3.1.6 penetration, n—the movement of matter through
Barrier Packaging
closures, porous materials, seams, and pinholes or other
E691 Practice for Conducting an Interlaboratory Study to
imperfections in protective clothing on a nonmolecular level.
Determine the Precision of a Test Method
3.1.6.1 Discussion—Forthistestmethod,thespecificmatter
F1494 Terminology Relating to Protective Clothing
is synthetic blood.
F1670/F1670M Test Method for Resistance of Materials
3.1.7 protective clothing, n—an item of clothing that is
Used in Protective Clothing to Penetration by Synthetic
specifically designed and constructed for the intended purpose
Blood
of isolating all or part of the body from a potential hazard; or,
F1671/F1671M Test Method for Resistance of Materials
isolating the external environment from contamination by the
Used in Protective Clothing to Penetration by Blood-
wearer of the clothing.
Borne Pathogens Using Phi-X174 Bacteriophage Penetra-
3.1.7.1 Discussion—Inthistestmethod,thepotentialhazard
tion as a Test System
of contact with blood or other body fluids is simulated.
2.2 ANSI/ASQC Standards:
3.1.8 synthetic blood, n—a mixture of a red dye/surfactant,
ANSI/ASQC Z1.4 Sampling Procedures and Tables for In-
thickening agent, and distilled water having a surface tension
spection by Attributes
and viscosity representative of blood and some other body
2.3 ISO Standard:
fluids, and the color of blood.
ISO 2859-1 Sampling Plans for Inspection by Attributes
3.1.8.1 Discussion—The synthetic blood in this test method
2.4 Military Standard: doesnotsimulateallofthecharacteristicsofrealbloodorbody
MIL-STD-105 Sampling Procedures and Tables for Inspec- fluids, for example, polarity (a wetting characteristic),
tion by Attributes coagulation, content of cell matter.
2.5 OSHA Standard: 3.1.9 For definitions of other protective clothing-related
CFRPart1910.1030 OccupationalExposuretoBlood-Borne terms used in this test method, refer to Terminology F1494.
Pathogens: Final Rule, Federal Register, Vol 56, No 235,
4. Summary of Test Method
Dec. 6, 1991, pp. 64175–64182.
4.1 Using a special test apparatus, a specimen is contacted
3. Terminology with synthetic blood under a continuously increasing mechani-
cal pressure until the synthetic blood penetrates the specimen
3.1 Definitions:
or a load of 90.7 kg (200 lb) is applied to a 57.2 mm (2.25 in.)
3.1.1 blood-borne pathogen, n—an infectious bacterium,
diameter portion of the specimen achieving a pressure on the
virus, or other disease-inducing microbe carried in blood or
tested specimen of 345 kPa (50 psig).
other potentially infectious body fluids.
4.2 The specimen’s non-contact side is observed to deter-
3.1.2 body fluid, n—any liquid produced, secreted, or ex-
mine if visual penetration occurs, and if so, at what mechanical
creted by the human body.
pressure the penetration occurs.
3.1.2.1 Discussion—In this test method, body fluids include
those liquids potentially infected with blood-borne pathogens, 4.3 In conducting a test, the cover plate containing a test
head is locked on the two side supports of the base plate of the
including, but not limited to: blood, semen, vaginal secretions,
cerebrospinal fluid, synovial fluid and peritoneal fluid, amni- test apparatus, the multi-position switch is turned to the
MANUAL UP position, and the test button on top of the
otic fluid, saliva in dental procedures, and any body fluid that
is visibly contaminated with blood, and all body fluids in control box is held down until visible penetration of the test
specimen by synthetic blood is observed through the circular
situations where it is difficult or impossible to differentiate
between body fluids (see 29 CFR Part 1910.1030). test head. Releasing the button stops the drive motor, and the
penetration pressure is shown digitally on the display unit and
3.1.3 body fluid simulant, n—a liquid which is used to act as
recorded by the technician.
a model for human body fluids.
5. Significance and Use
5.1 This test method was modeled after a procedure com-
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
monly known as the Elbow Lean Test. The Elbow Lean Test
Milwaukee, WI 53203, http://www.asq.org.
involves the application of synthetic blood to an ink pad,
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
placement of sample fabric over the blood-soaked pad, place-
4th Floor, New York, NY 10036, http://www.ansi.org.
Available from Standardization Documents Order Desk, DODSSP, Bldg. 4,
ment of a blotter over the sample fabric, and applying elbow or
Section D, 700 Robbins Ave., Philadelphia, PA 19111-5098, http://
dodssp.daps.dla.mil.
6 7
AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments, The boldface numbers in parentheses refer to the list of references at the end of
732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http:// this standard.
www.access.gpo.gov. Originally developed by W. L. Gore and Assoc. Inc., Elkton, MD 21921.
F1819 − 19
fingertip pressure on top of the blotter. The blotter is then quent penetration, of real blood and other body fluids through
examined for staining as evidence of blood penetration. This protective clothing materials.
test method provides similar procedures which standardize the
5.8 It is known that body fluids penetrating protective
test equipment and application of pressure through an adopted
clothing materials are likely to carry microbiological contami-
methodology.
nants; however, visual detection methods are not sensitive
5.2 This test method is intended to simulate actual use enough to detect minute amounts of liquid containing micro-
conditions wherein areas of the healthcare worker’s protective
organisms (4-6). No viral resistance claims can be made based
clothing are soaked with blood and compressed between the on this test method, as materials can pass this test method and
patient’s body and that of the healthcare worker, or similarly
fail Test Method F1671/F1671M.
between the healthcare worker and instruments. In both cases,
5.9 Part of the protocol for exposing the protective clothing
unconfined blood can move away from the pressure point
material specimens to synthetic blood involves applying me-
taking the path of least resistance rather than being contained
chanical pressure up to 345 kPa (50 psig). This mechanical
as in Test Methods F1670/F1670M and F1671/F1671M.
pressure has been documented to discriminate protective cloth-
5.3 This test method uses predominately mechanical pres-
ing material performance and correlate with visual penetration
sure as opposed to contained, hydrostatic pressure to demon-
results that are obtained with one type of human factors
strate liquid penetration resistance (1, 2). It simulates a single
validation, the Elbow Lean Test. The Elbow Lean Test does
insult in which the outer surfaces of a protective clothing item
not simulate all of the possible types of clinical exposure, as
are compressed at a steady rate by the wearer’s body against a
thereisonecontactwithliquidunderhighmechanicalpressure
wet surface. This steady rate of compression represents one
for a short duration. Some studies suggest that mechanical
potential use scenario. Other scenarios may result in a wide
pressures exceeding 345 kPa (50 psig) can occur during
variety of pressure ramp rates and profiles that are not
clinical use (7, 8).
simulated by the test apparatus.
NOTE 1—The mechanical pressure tester can be adjusted to evaluate
5.4 Because this test method provides quantitative results, it
materials at higher pressures.
is useful for discriminating differences in the liquid barrier
5.10 Testing prior to degradation by physical, chemical, and
performance of protective clothing materials. This test method
thermal stresses which could negatively impact the perfor-
can be used for measuring differences in the penetration
mance of the protective barrier could lead to a false sense of
pressure for protective clothing materials which do not pass
security. Consider tests which assess the impact of storage
Test Method F1670/F1670M.
conditions and shelf life for disposable products, and the
5.5 This test method is normally used to evaluate specimens
effects of laundering and sterilization for reusable products.
from individual finished items of protective clothing and
The integrity of the protective clothing can also be compro-
individual samples of materials that are candidates for items of
mised during use by such effects as flexing and abrasion (9).It
protective clothing.
is also possible that pre-wetting by contaminants such as
5.5.1 Finished items of protective clothing include gloves, alcohol and perspiration can compromise the integrity of the
arm shields, aprons, gowns, hoods, and boots. protective clothing. Furthermore, high relative humidity may
also affect the resistance of materials used in protective
5.5.2 The phrase ‘specimens from finished items’ encom-
clothing to penetration by blood and other body fluids. If these
passes seamed and other discontinuous regions, as well as the
conditions are of concern, evaluate the performance of protec-
usual continuous regions of protective clothing items.
tive clothing for synthetic blood penetration following an
5.6 Medical protective clothing materials are intended to be
appropriate pretreatment technique representative of the ex-
a barrier to blood, body fluids, and other potentially infectious
pected conditions of use.
materials. Many factors can affect the wetting and penetration
5.11 This test method involves a quantitative determination
characteristics of body fluids, such as surface tension,
viscosity, and polarity of the fluid, as well as the structure and of a protective clothing penetration resistance to synthetic
blood under specific test conditions. It can also be used as a
relative hydrophilicity or hydrophobicity of the materials. The
synthetic blood solution may exhibit different wetting behavior qualitative method for comparing the penetration resistance
characteristics of similar materials and as a material quality
on fabrics or films with identical structures but different
chemical compositions. The surface tension range for blood control or assurance procedure.
and body fluids (excluding saliva) is approximately 0.042 to
5.12 If this test method is used for quality control, perform
0.060 N/m (3). To help simulate the wetting characteristics of
proper statistical design and analysis of larger data sets where
blood and body fluids, the surface tension of the synthetic
more than three specimens are tested. This type of analysis
blood is adjusted to approximate the lower end of this surface
includes, but is not limited to, reporting the number of
tension range. The resulting surface tension of the synthetic
individual specimens tested and the average penetration pres-
blood is 0.042 6 0.002 N/m.
sure of specimens with a standard deviation. Data reported in
5.7 The synthetic blood mixture is prepared with a red dye this way helps establish confidence limits concerning product
to aid in visual detection and a thickening agent to simulate the performance.Examplesofacceptablesamplingplansarefound
flow characteristics of blood. The synthetic blood may not in references such as MIL-STD-105, ANSI/ASQC Z1.4, and
duplicate the polarity, and thus wetting behavior and subse- ISO 2859-1.
F1819 − 19
5.13 In the case of a dispute arising from differences in 6.4 Petri Dish, plastic, 93 by 93 by 15 mm.
reported results when using this test method for acceptance
6.5 Foam Pad, polyester, 0.64 mm (0.25 in.) thick, non-
testing of commercial shipments, the purchaser and the sup-
reticulated, with 90 pores/in., a compression ration of 3:1, and
plier should conduct comparative tests to determine if there is
free of surfactants and other additives, cut to fit the petri dish
a statistical bias between their laboratories. Competent statis- 11,10
dimensions.
tical assistance is recommended for investigation of bias.As a
6.6 Rod, poly (methyl methacrylate) (PMMA), approxi-
minimum, the two parties should take a group of test speci-
mately 2.5 mm in diameter by 300 mm in length, for saturating
mens which are as homogeneous as possible and which are
the foam pads with synthetic blood and removing air bubbles.
from a lot of the product of the type in question. The test
specimens should then be randomly assigned in equal numbers 6.7 Bubble Level, for leveling instrument.
to each laboratory for testing.The average results from the two
6.8 Ruler, graduated in 1-mm (0.05-in.) increments, for
laboratories should be compared using a non-parametric test
measuring the height of the synthetic blood in the petri dish.
forunpaireddataandanacceptableprobabilitylevelchosenby
the two parties before testing is begun. If a bias is found, either
7. Reagents
its cause must be found and corrected or the purchaser and the
12,10
7.1 Synthetic Blood —If synthetic blood is not
supplier must agree to interpret future test results with consid-
purchased, prepare using following ingredients:
eration to the known bias.
7.1.1 High Performance Liquid Chromatography (HPLC)
quality distilled water (1.0 L, pH 7.0 6 0.5).
6. Apparatus
12,10
7.1.2 Acrysol G111 Thickening Agent, 50.0 g.
12,10
6.1 Thickness Gauge, suitable for measuring thickness to
7.1.3 Red Dye containing colorant and surfactant,
the nearest 0.02 mm (0.001 in.) in accordance with Test
10.0 g.
Method D1777, used to determine the thickness of each
7.1.4 To reduce biological contamination, boil the distilled
protective clothing material specimen tested.
water for 5 min and allow to cool to room temperature before
9,10
mixing. Measure amount of distilled water at 20 °C (61 °C)
6.2 Mechanical Penetration Tester, shown in Fig. 1,
after boiling.
consisting of a base plate, a variable speed drive motor, a
7.1.5 Addthethickeningagenttothedistilledwaterandmix
belted gear-driven screw, a lower platform, load cell, upper
45 min at room temperature on a magnetic stirring plate.
platform, cover plate, control box, and display unit. The driver
7.1.6 Add the red dye and mix1hor more.
motor is connected to the screw through a belted gear. The
screw is then connected to the underside of the lower platform
NOTE 3—The red dye will stain skin, clothes, and work surfaces.
which moves up and down, in tubular sleeves when the screw
7.1.7 Measure the surface tension of the solution using Test
turns at a rate of 827.5 RPM which corresponds to a platform
Method D1331, DuNouy ring (MethodA).The surface tension
vertical speed of 60.20 mm/min (0.479 6 0.008 in./min). The
measurement declines over time in an undisturbed dish. After
top of the lower platform is fastened to the bottom of the load
filling the sample container using the mixing method
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F1819 − 07 (Reapproved 2013) F1819 − 19
Standard Test Method for
Resistance of Materials Used in Protective Clothing to
Penetration by Synthetic Blood Using a Mechanical
Pressure Technique
This standard is issued under the fixed designation F1819; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
Workers, primarily those in the health care healthcare profession, involved in treating and caring for
individuals injured or sick, can be exposed to biological liquids capable of transmitting disease. These
diseases, which may be caused by a variety of microorganisms, can pose significant risks to life and
health. This is especially true of blood-borne viruses which cause Hepatitis (Hepatitis B Virus (HBV)
and Hepatitis C Virus (HCV)) and Acquired Immune Deficiency Syndrome (AIDS) (Human
Immunodeficiency Virusesacquired immune deficiency syndrome (AIDS) (human immunodeficiency
viruses (HIV)). Since engineering controls cannot eliminate all possible exposures, attention is placed
on reducing the potential for direct skin contact through the use of protective clothing that resists
penetration (29 CFR Part 1910.1030). This test method was developed to help assess the effectiveness
of materials used in protective clothing for protecting the wearer against contact with body fluids that
potentially contain blood-borne pathogens. Using synthetic blood, this test method is intended to
determine the amount of mechanical pressure that will cause penetration of a liquid through a material
used in protective clothing.
1. Scope
1.1 This test method is used to evaluate the resistance of materials used in protective clothing to synthetic blood under the
conditions of liquid contact and increasing direct mechanical pressure. The penetration resistance of protective clothing is based
on visual detection of synthetic blood penetration at a specific applied mechanical pressure.
1.2 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method must
review modes for work/clothing exposure and assess the appropriateness of this test method for their specific application.
1.3 This test method addresses only the performance of materials or certain material constructions (for example, seams) used
in protective clothing. This test method does not address the design, overall construction, components, or interfaces of garments,
or other factors which may affect the overall protection offered by the protective clothing.
1.4 The values in SI units or in other units shall be regarded separately as standard. The values stated in each system must be
used independently of the other, without combining values in any way.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
This test method is under the jurisdiction of ASTM Committee F23 on Personal Protective Clothing and Equipment and is the direct responsibility of Subcommittee
F23.40 on Biological.
Current edition approved Jan. 1, 2013May 1, 2019. Published January 2013May 2019. Originally approved in 1997. Last previous edition approved in 20072013 as
F1819F1819 – 07 (2013).-07. DOI: 10.1520/F1819-07R13.10.1520/F1819-19.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1819 − 19
2. Referenced Documents
2.1 ASTM Standards:
D1331 Test Methods for Surface and Interfacial Tension of Solutions of Paints, Solvents, Solutions of Surface-Active Agents,
and Related Materials
D1777 Test Method for Thickness of Textile Materials
D3776D3776/D3776M Test Methods for Mass Per Unit Area (Weight) of Fabric
E105 Practice for Probability Sampling of Materials
E171E171/E171M Practice for Conditioning and Testing Flexible Barrier Packaging
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
F1494 Terminology Relating to Protective Clothing
F1670F1670/F1670M Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
F1671F1671/F1671M 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
2.2 ANSI/ASQC Standards:
ANSI/ASQC Z1.4 Sampling Procedures and Tables for Inspection by Attributes
2.3 ISO Standard:
ISO 2859-1 Sampling Plans for Inspection by Attributes
2.4 Military Standard:
MIL-STD-105 Sampling Procedures and Tables for Inspection by Attributes
2.5 OSHA Standard:
CFR Part 1910.1030 Occupational Exposure to Blood-borneBlood-Borne Pathogens: Final Rule, Federal Register, Vol 56, No
235, Dec. 6, 1991, pp. 64175–64182.
3. Terminology
3.1 Definitions:
3.1.1 blood-borne pathogen, n—an infectious bacterium, virus, or other disease inducing disease-inducing microbe carried in
blood or other potentially infectious body fluids.
3.1.2 body fluid, n—any liquid produced, secreted, or excreted by the human body.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http://www.asq.org.
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Available from Standardization Documents Order Desk, DODSSP, Bldg. 4, Section D, 700 Robbins Ave., Philadelphia, PA 19111-5098, http://dodssp.daps.dla.mil.
Available from U.S. Government Printing Office Superintendent of Documents, 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
www.access.gpo.gov.
3.1.2.1 Discussion—
In this test method, body fluids include those liquids potentially infected with blood-borne pathogens, including, but not limited
to,to: blood, semen, vaginal secretions, cerebrospinal fluid, synovial fluid and peritoneal fluid, amniotic fluid, saliva in dental
procedures, and any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or
impossible to differentiate between body fluids (see 29 CFR Part 1910.1030).
3.1.3 body fluid simulant, n—a liquid which is used to act as a model for human body fluids.
3.1.4 hydrostatic pressure, n—the force exerted by a static liquid (1).
3.1.5 mechanical pressure, n—the force exerted by one solid object upon another that it is touching (1).
3.1.6 penetration, n—the movement of matter through closures, porous materials, seams, and pinholes or other imperfections
in protective clothing on a nonmolecular level.
The boldface numbers in parentheses refer to the list of references at the end of this standard.
3.1.6.1 Discussion—
For this test method, the specific matter is synthetic blood.
F1819 − 19
3.1.7 protective clothing, n—an item of clothing that is specifically designed and constructed for the intended purpose of
isolating all or part of the body from a potential hazard; or, isolating the external environment from contamination by the wearer
of the clothing.
3.1.7.1 Discussion—
In this test method, the potential hazard of contact with blood or other body fluids is simulated.
3.1.8 synthetic blood, n—a mixture of a red dye/surfactant, thickening agent, and distilled water having a surface tension and
viscosity representative of blood and some other body fluids, and the color of blood.
3.1.8.1 Discussion—
The synthetic blood in this test method does not simulate all of the characteristics of real blood or body fluids, for example, polarity
(a wetting characteristic), coagulation, content of cell matter.
3.1.9 For definitions of other protective clothing-related terms used in this test method, refer to Terminology F1494.
4. Summary of Test Method
4.1 Using a special test apparatus, a specimen is contacted with synthetic blood under a continuously increasing mechanical
pressure until the synthetic blood penetrates the specimen or a load of 90.7 kg (200 lbs)lb) is applied to a 57.2 mm (2.25 in.)
diameter portion of the specimen achieving a pressure on the tested specimen of 345 kPa (50 psig).
4.2 The specimen’s non-contact side is observed to determine if visual penetration occurs, and if so, at what mechanical pressure
the penetration occurs.
4.3 In conducting a test, the cover plate containing a test head is locked on the two side supports of the base plate of the test
apparatus, the multi-position switch is turned to the manual upMANUAL UP position, and the test button on top of the control
box is held down until visible penetration of the test specimen by synthetic blood is observed through the circular test head.
Releasing the button stops the drive motor, and the penetration pressure is shown digitally on the display unit and recorded by the
technician.
5. Significance and Use
5.1 This test method was modeled after a procedure commonly known as the Elbow Lean Test. The Elbow Lean Test involves
the application of synthetic blood to an ink pad, placement of sample fabric over the blood soaked blood-soaked pad, placement
of a blotter over the sample fabric, and applying elbow or fingertip pressure on top of the blotter. The blotter is then examined for
staining as evidence of blood penetration. This test method provides similar procedures which standardize the test equipment and
application of pressure through an adopted methodology.
5.2 This test method is intended to simulate actual use conditions wherein areas of the health care healthcare worker’s protective
clothing are soaked with blood and compressed between the patient’s body and that of the health care healthcare worker, or
similarly between the health care healthcare worker and instruments. In both cases, unconfined blood can move away from the
pressure point taking the path of least resistance rather than being contained as in Test Methods F1670F1670/F1670M and
F1671F1671/F1671M.
5.3 This test method uses predominately mechanical pressure as opposed to contained, hydrostatic pressure to demonstrate
liquid penetration resistance (1, 2). It simulates a single insult in which the outer surfaces of a protective clothing item are
compressed at a steady rate by the wearer’s body against a wet surface. This steady rate of compression represents one potential
use scenario. Other scenarios may result in a wide variety of pressure ramp rates and profiles that are not simulated by the test
apparatus.
5.4 Because this test method provides quantitative results, it is useful for discriminating differences in the liquid barrier
performance of protective clothing materials. This test method can be used for measuring differences in the penetration pressure
for protective clothing materials which do not pass Test Method F1670F1670/F1670M.
5.5 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.
5.5.1 Finished items of protective clothing include gloves, arm shields, aprons, gowns, hoods, and boots.
5.5.2 The phrase specimens‘specimens from finished itemsitems’ encompasses seamed and other discontinuous regions, as well
as the usual continuous regions of protective clothing items.
Originally developed by W.L.Gore and Assoc.,W. L. Gore and Assoc. Inc., Elkton, MD 21921.
F1819 − 19
5.6 Medical protective clothing materials are intended to be a barrier to blood, body fluids, and other potentially infectious
materials. Many factors can affect the wetting and penetration characteristics of body fluids, such as surface tension, viscosity, and
polarity of the fluid, as well as the structure and relative hydrophilicity or hydrophobicity of the materials. The synthetic blood
solution may exhibit different wetting behavior on fabrics or films with identical structures but different chemical compositions.
The surface tension range for blood and body fluids (excluding saliva) is approximately 0.042 to 0.060 N/m (3). To help simulate
the wetting characteristics of blood and body fluids, the surface tension of the synthetic blood is adjusted to approximate the lower
end of this surface tension range. The resulting surface tension of the synthetic blood is 0.042 6 0.002 N/m.
5.7 The synthetic blood mixture is prepared with a red dye to aid in visual detection and a thickening agent to simulate the flow
characteristics of blood. The synthetic blood may not duplicate the polarity, and thus wetting behavior and subsequent penetration,
of real blood and other body fluids through protective clothing materials.
5.8 It is known that body fluids penetrating protective clothing materials are likely to carry microbiological contaminants;
however, visual detection methods are not sensitive enough to detect minute amounts of liquid containing microorganisms (44-6,
5, 6). No viral resistance claims can be made based on this test method, as materials can pass this test method and fail Test Method
F1671F1671/F1671M.
5.9 Part of the protocol for exposing the protective clothing material specimens to synthetic blood involves applying mechanical
pressure up to 345 kPa (50 psig). This mechanical pressure has been documented to discriminate protective clothing material
performance and correlate with visual penetration results that are obtained with one type of human factors validation, the Elbow
Lean Test. The Elbow Lean Test does not simulate all of the possible types of clinical exposure, as there is one contact with liquid
under high mechanical pressure for a short duration. Some studies suggest that mechanical pressures exceeding 345 kPa (50 psig)
can occur during clinical use (7, 8).
NOTE 1—The mechanical pressure tester can be adjusted to evaluate materials at higher pressures.
5.10 Testing prior to degradation by physical, chemical, and thermal stresses which could negatively impact the performance
of the protective barrier,barrier could lead to a false sense of security. Consider tests which assess the impact of storage conditions
and shelf life for disposable products, and the effects of laundering and sterilization for reusable products. The integrity of the
protective clothing can also be compromised during use by such effects as flexing and abrasion (9). It is also possible that
prewettingpre-wetting by contaminants such as alcohol and perspiration can compromise the integrity of the protective clothing.
Furthermore, high relative humidity may also affect the resistance of materials used in protective clothing to penetration by blood
and other body fluids. If these conditions are of concern, evaluate the performance of protective clothing for synthetic blood
penetration following an appropriate pretreatment technique representative of the expected conditions of use.
5.11 This test method involves a quantitative determination of a protective clothing penetration resistance to synthetic blood
under specific test conditions. It can also be used as a qualitative method for comparing the penetration resistance characteristics
of similar materials and as a material quality control or assurance procedure.
5.12 If this test method is used for quality control, perform proper statistical design and analysis of larger data sets where more
than three specimens are tested. This type of analysis includes, but is not limited to, reporting the number of individual specimens
tested and the average penetration pressure of specimens with a standard deviation. Data reported in this way helps establish
confidence limits concerning product performance. Examples of acceptable sampling plans are found in references such as
MIL-STD-105, ANSI/ASQC Z1.4, and ISO 2859–1.2859-1.
5.13 In the case of a dispute arising from differences in reported results when using this test method for acceptance testing of
commercial shipments, the purchaser and the supplier should conduct comparative tests to determine if there is a statistical bias
between their laboratories. Competent statistical assistance is recommended for investigation of bias. As a minimum, the two
parties should take a group of test specimens which are as homogeneous as possible and which are from a lot of the product of
the type in question. The test specimens should then be randomly assigned in equal numbers to each laboratory for testing. The
average results from the two laboratories should be compared using a non-parametric test for unpaired data and an acceptable
probability level chosen by the two parties before testing is begun. If a bias is found, either its cause must be found and corrected
or the purchaser and the supplier must agree to interpret future test results with consideration to the known bias.
6. Apparatus
6.1 Thickness Gauge, suitable for measuring thickness to the nearest 0.02 mm (0.001 in.),in.) in accordance with Test Method
D1777, used to determine the thickness of each protective clothing material specimen tested.
9,10
6.2 Mechanical Penetration Tester, shown in Fig. 1, consisting of a base plate, a variable speed drive motor, a belted gear
driven gear-driven screw, a lower platform, load cell, upper platform, cover plate, control box, and display unit. The driver motor
The sole source of supply of the apparatus known to the committee at this time is Johnson, Moen & Co., 2505 Northridge Lane NE, Rochester, MN 55906.
The supplier named is the sole source of supply known to the committee at this time. If you are aware of alternative suppliers, please provide this information to ASTM
Headquarters. Your comments will receive careful consideration at a meeting of the responsible technical committee, which you may attend.
F1819 − 19
FIG. 1 Mechanical Penetration Tester

F1819 − 19
is connected to the screw through a belted gear. The screw is then connected to the underside of the lower platform which moves
up and down, in tubular sleeves when the screw turns at a rate of 827.5 RPM which corresponds to a platform vertical speed of
6 0.20 60.20 mm/min (0.479 6 0.008 in./min). The top of the lower platform is fastened to the bottom of the load cell, and the
top of the load cell is fastened to the underside of the upper platform. The upper platform provides a location for resting the petri
dish containing a foam pad and synthetic blood and the specimen. The control box has a test button and multi-position switch with
settings for down, off, auto up,DOWN, OFF, AUTO UP, and manual up.MANUAL UP. A display unit indicates the load (weight)
from the load cell in lbs.lb.
NOTE 2—If desired, the rate of compression may be adjusted higher or lower. This may slightly alter the rate of pressure change in the low pressure
low-pressure region of the pressure profile (during sponge compression), but will not significantly alter the rate of pressure change in the high pressure
high-pressure region of the pressure profile (above sponge compression).
6.2.1 Since small differences in the screw and control box may exist between different mechanical pressure testers, ensure that
the platform moves at a speed of 12.17 6 0.20 mm/min (0.479 6 0.008 in/min).in./min).
2 2
6.3 Circular Test Head, transparent, with a diameter of 57.2 mm 57.2 mm (2.25 in.) and a surface area of 2570 mm (3.976 in. ).
6.4 Petri Dish, plastic, 93 by 93 by 15 mm.
6.5 Foam Pad, polyester, 0.64 mm (0.25 in.) thick, non-reticulated, with 90 pores/in., a compression ration of 3:1, and free of
11,10
surfactants and other additives, cut to fit the petri dish dimensions.
6.6 Rod, poly (methyl methacrylate) (PMMA), approximately 2.5 mm in diameter by 300 mm in length, for saturating the foam
pads with synthetic blood and removing air bubbles.
6.7 Bubble Level, for leveling instrument.
6.8 Ruler, graduated in 1 mm (0.05 in.
...