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ASTM F3267-22

(Specification)

Standard Specification for Protective Clothing for Use Against Liquid Chemotherapy and Other Liquid Hazardous Drugs

Standard Specification for Protective Clothing for Use Against Liquid Chemotherapy and Other Liquid Hazardous Drugs

SCOPE
1.1 This specification establishes design, performance, documentation, and labeling requirements and provides test methods for protective clothing used in preventing exposure to liquid chemotherapy and other liquid hazardous drugs.  
1.1.1 The principal requirement of this specification is permeation resistance testing of the protective clothing barrier material and seams to a specified battery of seven chemotherapy drugs. Two levels of protective clothing barrier material and seam performance are established for complying with Part A labeling requirements specific to these seven liquid chemotherapy drugs.
1.1.1.1 Broad chemotherapy drug protection is based on the protective clothing barrier material and seams demonstrating breakthrough detection times of 30 min or more for the seven specified chemotherapy drugs.
1.1.1.2 Selective chemotherapy drug protection is based on the protective clothing barrier material and seams demonstrating breakthrough detection times of 30 min or more for at least five of the seven specified chemotherapy drugs.  
1.1.2 It is also possible to report permeation resistance test results for additional liquid chemotherapy and other liquid hazardous drugs of interest as determined by the manufacturer or end user organization using the same breakthrough detection criteria for individual drugs for complying with the Part B labeling requirements.  
1.1.3 Protective clothing meeting this specification is also required to meet minimum flammability requirements, and if used as a medical device, biocompatibility (if used for breached skin contact), and demonstrate sterility assurance, if sterilized prior to use.  
1.1.4 Physical properties that indicate the strength, durability, and breathability of the protective clothing are optionally reported.  
1.1.5 Additional requirements are established for the label and user information to be provided for protective clothing meeting this specification.  
1.1.6 This specification also requires products intended to be used as medical devices such as surgical gowns and isolation gowns to meet the respective requirements of AAMI PB70, Specification F2407/F2407M, and Specification F3352/F3352M, as applicable.  
1.2 This specification does not address all conditions of exposure for individuals who wear protective clothing in the manufacture, transport, compounding, preparation, and administration of liquid chemotherapy and other hazardous drugs in addition to patient care activities and spills where contaminated items with these drugs are encountered.  
1.3 This specification does not address chemotherapy drugs or hazardous drugs that may be encountered in the form of a vapor or aerosol and does not provide any criteria for respiratory protection.  
1.4 This specification does not address the selection, use, or care of protective clothing used for protection against liquid chemotherapy or other liquid hazardous drugs. While this specification does not specifically determine which barrier material to select, the results of the tests described in this specification are useful for selecting barrier materials by comparing the test results among different materials under consideration. See USP 800, Hazardous Drugs—Handling In Healthcare Settings, for specific guidelines on the selection, use, and care of personal protective equipment for protection of healthcare workers against chemotherapy or other hazardous drugs.  
1.5 This specification is intended to provide the basis for manufacturers or suppliers to make specific claims that protective clothing products provide protection against liquid chemotherapy and other liquid hazardous drugs.  
1.6 The values stated 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.  
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its u...

General Information

Status
Published
Publication Date
30-Nov-2022
ICS
13.340.10 - Protective clothing
Technical Committee
F23 - Personal Protective Clothing and Equipment
Drafting Committee
F23.30 - Chemicals
Current Stage
Ref Project

Relations

Refers
ASTM D1776/D1776M-20 - Standard Practice for Conditioning and Testing Textiles
Effective Date
01-Feb-2020
Refers
ASTM D3787-16(2020) - Standard Test Method for Bursting Strength of Textiles—Constant-Rate-of-Traverse (CRT) Ball Burst Test
Effective Date
01-Jul-2020

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ASTM F3267-22 - Standard Specification for Protective Clothing for Use Against Liquid Chemotherapy and Other Liquid Hazardous DrugsASTM F3267-22 - Standard Specification for Protective Clothing for Use Against Liquid Chemotherapy and Other Liquid Hazardous Drugs
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ASTM F3267-22 - Standard Specification for Protective Clothing for Use Against Liquid Chemotherapy and Other Liquid Hazardous Drugs
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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:F3267 −22
Standard Specification for
Protective Clothing for Use Against Liquid Chemotherapy
1
and Other Liquid Hazardous Drugs
This standard is issued under the fixed designation F3267; 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.
1. Scope 1.1.6 This specification also requires products intended to
be used as medical devices such as surgical gowns and
1.1 This specification establishes design, performance,
isolation gowns to meet the respective requirements of AAMI
documentation, and labeling requirements and provides test
PB70, Specification F2407/F2407M, and Specification F3352/
methods for protective clothing used in preventing exposure to
F3352M, as applicable.
liquid chemotherapy and other liquid hazardous drugs.
1.1.1 The principal requirement of this specification is
1.2 This specification does not address all conditions of
permeation resistance testing of the protective clothing barrier
exposure for individuals who wear protective clothing in the
material and seams to a specified battery of seven chemo-
manufacture, transport, compounding, preparation, and admin-
therapy drugs. Two levels of protective clothing barrier mate-
istration of liquid chemotherapy and other hazardous drugs in
rial and seam performance are established for complying with
additiontopatientcareactivitiesandspillswherecontaminated
Part A labeling requirements specific to these seven liquid
items with these drugs are encountered.
chemotherapy drugs.
1.3 This specification does not address chemotherapy drugs
1.1.1.1 Broad chemotherapy drug protection is based on the
or hazardous drugs that may be encountered in the form of a
protective clothing barrier material and seams demonstrating
vapor or aerosol and does not provide any criteria for respira-
breakthrough detection times of 30 min or more for the seven
tory protection.
specified chemotherapy drugs.
1.1.1.2 Selective chemotherapy drug protection is based on
1.4 This specification does not address the selection, use, or
the protective clothing barrier material and seams demonstrat-
care of protective clothing used for protection against liquid
ing breakthrough detection times of 30 min or more for at least
chemotherapy or other liquid hazardous drugs. While this
five of the seven specified chemotherapy drugs.
specification does not specifically determine which barrier
1.1.2 It is also possible to report permeation resistance test
material to select, the results of the tests described in this
results for additional liquid chemotherapy and other liquid
specification are useful for selecting barrier materials by
hazardous drugs of interest as determined by the manufacturer
comparing the test results among different materials under
orenduserorganizationusingthesamebreakthroughdetection
consideration. See USP 800, Hazardous Drugs—Handling In
criteria for individual drugs for complying with the Part B
Healthcare Settings, for specific guidelines on the selection,
labeling requirements.
use,andcareofpersonalprotectiveequipmentforprotectionof
1.1.3 Protective clothing meeting this specification is also
healthcare workers against chemotherapy or other hazardous
required to meet minimum flammability requirements, and if
drugs.
used as a medical device, biocompatibility (if used for
1.5 This specification is intended to provide the basis for
breached skin contact), and demonstrate sterility assurance, if
manufacturers or suppliers to make specific claims that protec-
sterilized prior to use.
tive clothing products provide protection against liquid che-
1.1.4 Physical properties that indicate the strength,
motherapy and other liquid hazardous drugs.
durability, and breathability of the protective clothing are
optionally reported.
1.6 The values stated in SI units or in other units shall be
1.1.5 Additional requirements are established for the label
regarded separately as standard. The values stated in each
and user information to be provided for protective clothing
system must be used independently of the other, without
meeting this specification.
combining values in any way.
1.7 This standard does not purport to address all of the
1
This specification is under the jurisdiction of ASTM Committee F23 on
safety concerns, if any, associated with its use. It is the
Personal Protective Clothing and Equipment and is the direct responsibility of
responsibility of the user of this standard to establish appro-
Subcommittee F23.30 on Chemicals
...

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SIGNIFICANCE AND USE
2.1 This guide is intended to encourage thorough and consistent documentation of airborne particle penetration testing and its results.  
2.2 Uniform information and performance data increase the likelihood of selecting proper particle protective clothing by direct comparison of one material with another.  
2.3 A standard format for test information and data also encourages computer storage of test results for easy retrieval, comparison, and correlations.
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1.1 This guide provides a format for documenting information and performance data for an airborne particle penetration test.  
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1.2.1 Description of material tested,  
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ABSTRACT
This specification establishes the requirements for the performance, documentation, and labeling of surgical gowns used in the healthcare facilities. It does not however cover all the requirements that a healthcare facility deems necessary to select a product, nor does it address criteria for evaluating experimental products. Barrier testing shall be conducted to determine the impact penetration, hydrostatic resistance, and viral penetration resistance performance of the critical zone(s) of the surgical gown. The physical properties of the critical zone(s) of the surgical gown shall also be tested and shall conform to the following requirements: tensile strength, tear resistance, seam strength, lint generation, evaporative resistance, and water vapor transmission rate. General safety requirements shall be set based on biocompatibility, sterility assurance, flame spread, and natural rubber latex specifications.
SIGNIFICANCE AND USE
4.1 This specification provides minimum requirements for surgical gowns used for protection of healthcare workers where the potential for exposure to blood, body fluids, and other potentially infectious materials exists. The specification requires barrier testing based on the system of classifying gowns established in ANSI/AAMI PB70 and sets general safety requirements for surgical gowns based on biocompatibility, sterility assurance, and flame spread. Performance requirements are established for important physical properties, including tensile strength, tear strength, and seam strength. Methods to be used for optional reporting of performance of linting resistance, evaporative resistance, water vapor transmission rate, and abrasion resistance are provided.  
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4.4 Additional information on the processing of multiple-use surgical gowns is provided in ANSI/AAMI ST65.  
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SCOPE
1.1 This specification establishes requirements for the performance, documentation, and labeling of surgical gowns used in healthcare facilities. Four levels of barrier properties for surgical gowns are specified in ANSI/AAMI PB70 and are included in this specification for reference purposes.
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1.1 This specification establishes minimum requirements for the performance and labeling of isolation gowns intended for use by healthcare workers to provide protection for standard and transmission-based precautions. The intended use of this specification is to ensure the performance properties of isolation gowns for the protection of the wearer. Four levels of barrier properties for isolation gowns are specified in ANSI/AAMI PB 70, and are included in this specification for reference purposes.  
1.2 There are other types of gowns that are used in healthcare settings, including: cover gowns, procedure gowns, comfort gowns, precaution gowns, and open-back gowns. All gowns not meeting the definition of isolation gown in 3.1.7 as defined by ANSI/AAMI PB70 are excluded from this standard.  
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1.4 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.  
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Standard Test Method for Thermal Resistance, Evaporative Resistance, and Total Heat Loss Measurements of Clothing Materials Using a Sweating Hot Plate

SIGNIFICANCE AND USE
4.1 The thermal resistance, evaporative resistance, and total heat loss provided by fabrics, films, coatings, foams, and leathers, including multi-layer assemblies, is of considerable importance in determining their suitability for use in fabricating protective clothing systems.  
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5.1 Use this test method to measure the thermal protection provided by different materials, garments, clothing ensembles, and systems when exposed to a specified fire (see 3.2.2, 3.2.3, 4.1, and 10.4).  
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1.1 This test method is used to provide predicted human skin burn injury for single-layer garments or protective clothing ensembles mounted on a stationary upright instrumented manikin which are then exposed in a laboratory to a simulated fire environment having controlled heat flux, flame distribution, and duration. The average exposure heat flux is 84 kW/m2 (2 cal/s·cm2), with durations up to 20 s.  
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1.4 The measurements obtained and observations noted can only apply to the particular garment(s) or ensemble(s) tested using the specified heat flux, flame distribution, and duration.  
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SIGNIFICANCE AND USE
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SCOPE
1.1 This guide is intended to aid in the application of standards for the development, specification, and selection of chemical protective clothing with the ultimate goal of maintaining the safety and health of workers who come into contact with hazardous chemicals.  
1.2 This guide provides a short description of each referenced standard and then makes specific recommendations for the use of these standards. The referenced standards are organized under the following headings: Material Chemical Resistance, Material Physical Properties, Seam and Closure Performance, and Overall Clothing Performance.  
1.3 No protocol can ensure the selection of protective clothing that guarantees worker protection. The purpose of testing is to generate data and information that will allow the selection of the most appropriate clothing. Ultimately, clothing selection is based on technical evaluation of available information and professional assessment of risk.  
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SIGNIFICANCE AND USE
5.1 This test method assesses the cut resistance of a material when exposed to a cutting edge under specified loads. Data obtained from this test method can be used to compare the cut resistance of different materials.  
5.2 This test method only addresses that range of cutting hazards that are related to a cutting action by a smooth sharp edge across the surface of the material. It is not representative of any other cutting hazard to which the material may be subjected, such as serrated edges, saw blades, or motorized cutting tools. Nor is it representative of puncture, tear, or other modes of fabric failure.
SCOPE
1.1 This test method covers the measurement of the cut resistance of a material when mounted on a specimen holder and subjected to a cutting edge under a specified load using a tomodynamometer.2  
1.1.1 This procedure is not valid for high-porosity materials which allow cutting edge contact with the mounting surface prior to cutting.  
1.1.2 Test apparatus may have limitations in testing materials with a thickness greater than 20 mm.  
1.2 The values stated in SI units are to be regarded as standard. The values given in parentheses after SI units are provided for information only and are not considered standard.  
1.3 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.  
1.4 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.

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Standard Test Method for Measuring the Cooling Energy Provided by Wicking Liquid Moisture and Evaporating It from Clothing Materials Using a Sweating Hot Plate

SIGNIFICANCE AND USE
4.1 A clothing material’s ability to assist in the evaporation of liquid sweat by managing liquid moisture is of considerable importance when trying to maximize cooling and comfort benefits to the wearer while active. Understanding how much energy is released back to the skin is critical in determining their suitability for use in fabricating protective clothing systems or athletic wear.  
4.1.1 The cooling energy released back to the wearer can be significantly affected by environmental conditions. Extreme care must be taken when using standard results measured under standard testing conditions to determine a material’s suitability for use in conditions outside the testing conditions.  
4.2 This test method accounts for a clothing material’s ability to assist in evaporating liquid water during a sweating phase, as well as its ability to dry after the cessation of sweating.  
4.2.1 A large amount of cooling energy released from clothing materials during active work (sweating) is often seen as a positive, as it would assist in keeping the body cooler.  
4.2.2 A large amount of cooling energy released from clothing materials after active work (no sweating) is often seen as a negative, as it known to cause a chilling effect to the wearer.  
4.2.3 The longer it takes for a clothing material to dry after becoming wet is perceived as a negative, as it increases the potential for chilling the wearer.  
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SCOPE
1.1 This test method covers the measurement of the cooling energy released back to the wearer’s skin by a clothing material’s ability to move and evaporate controlled dosages of water under controlled ambient conditions using a sweating hot plate.  
1.1.1 This test method establishes procedures for measuring the cooling energy during a simulated “sweating” phase and in a drying phase. Calculations are also provided to determine the drying time and how efficient the clothing material is at assisting in the evaporation of liquid water by comparing it to the maximum amount of energy that can be lost.  
1.2 This test method does not address all properties that affect a clothing material’s ability to lose heat from the body. Consider measuring properties such as air permeability, insulation, and evaporative resistance.  
1.3 The values in SI units shall be regarded as standard. No other units of measurement are included in the standard.  
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ASTM F1458-15(2022)(Test Method)
Standard Test Method for Measurement of Cut Resistance to Chainsaw of Foot Protective Devices

SIGNIFICANCE AND USE
5.1 The purpose of this test method is to provide a measurable criterion of performance defining the level of cut resistance to the cutting action of a saw chain provided by foot protective devices.  
5.2 The protection which can be demonstrated by the foot protective devices tested in accordance with this test method is achieved by: (1) the material resisting cutting when put in contact with the moving saw chain; (2) a part of the material being drawn into the saw chain and drive mechanism to block the saw chain movement; (3) the materials resisting cutting and absorbing rotational energy so that saw chain speed can be slowed down sufficiently to stop the movement of the saw chain; or (4) any combination of these.  
5.3 In case of a dispute arising from differences in reported test results, when using this test method for acceptance testing of commercial shipments, the purchaser and the supplier should perform comparative tests to determine if there is a statistical bias between their laboratories. Competent statistical assistance is recommended for the investigation of bias. As a minimum, the two parties should take a group of test specimens from the same lot of components to be evaluated. The test specimens should then be randomly assigned in equal numbers to each laboratory for testing. If a bias is found, either its cause must be determined and corrected, or the purchaser and the supplier must agree to interpret future test results in light of the known bias.
SCOPE
1.1 This test method measures cut resistance of foot protective devices that are designed to protect the foot when operating a chainsaw.  
1.2 This test method may be used to test for compliance to minimum performance requirements in established safety standards.  
1.2.1 By agreement between the purchaser and the supplier, or as required by established safety standards, this test method can be used to determine any one or both of the following: (1) chain speed 50 (CS50), (2) success/failure (jamming/chain stop) at specified chain speed.  
1.3 This test method may be used to determine levels of protection for areas of coverage as stipulated in established safety standards.  
1.4 The values stated in SI units are to be regarded as standard.
Note 1: The values stated in each system may not be exact equivalents; therefore, 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.

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ASTM
ASTM F3538-22(Test Method)
Standard Test Method for Measuring Heat Transmission Through Flame-Resistant Materials for Clothing in Flame Exposure Using a Cylindrical Specimen Holder

SIGNIFICANCE AND USE
5.1 This test method is intended for the determination of the cylinder heat transfer performance value of a flame-resistant material or combination of materials when exposed to a continuous and constant heat source. This is used to compare materials used in flame-resistant clothing for workers when exposed to combined convective and radiant thermal hazards.
Note 3: Air movement at the face of the specimen and around the calorimeter can affect the measured heat transferred due to forced convective heat losses. Minimizing air movement around the specimen and test apparatus will aid in the repeatability of the results.  
5.2 This test method maintains the specimen with and without air gaps in a static, horizontal position and does not involve movement unless the test specimen naturally changes due to the thermal exposure.  
5.3 This test method specifies a standardized 84 ± 2 kW/m2 (2 ± 0.05 cal/cm2·s) exposure condition. Different exposure conditions have the potential to produce different results. Use of other exposure conditions that are representative of the expected hazard are allowed but shall be reported with the results, along with a determination of the exposure energy level stability.  
5.4 This test method does not predict skin burn injury from the heat exposure.  
5.5 This test method is similar to Test Method F2700 in that it uses the same energy heat source, water-cooled shutter, data acquisition, and measures the heat transfer through protective clothing materials using a copper calorimeter. This test method differs from Test Method F2700 in the usage of an eccentric instrumented cylinder mounted horizontally that allows for the thermal shrinkage of materials when tested.
SCOPE
1.1 This test method measures the thermal response of a material or combination of materials using a combined convective/radiant heat transmission apparatus consisting of an eccentric cylindrical test sensor. It can be used to estimate the non-steady state thermal transfer through flame-resistant materials used in clothing when subjected to a continuous, combined convective and radiant heat exposure. The average incident heat flux is 84 kW/m2 (2 cal/cm2·s), with durations up to 30 s.  
1.1.1 This test method is not applicable to materials that melt, drip, or cause falling debris during the test.
Note 1: Because of the arrangement of the equipment, if materials melt, drip, or cause falling debris during the test, the test result is invalid.  
1.2 Heat transmission through clothing is largely determined by its thickness, including any air gaps. The air gaps can vary considerably in different areas of the human body. This method provides a means of grading materials when tested under standard test conditions and an air gap exists between the fabric and the sensor. During the exposure, fabric temperatures can exceed 400 °C. At these temperatures some fabrics are not dimensionally stable and can shrink or stretch. The cylindrical geometry used in this test method allows such motion to occur, which will affect the time to achieve the end point of the test. These effects are not demonstrated in planar geometry test methods such as Test Method F2700.  
1.3 This test method is used to measure and describe the response of materials, products, or assemblies to heat under controlled conditions, but does not by itself incorporate all factors required for fire hazard or fire risk assessment of the materials, products, or assemblies under actual fire conditions.  
1.4 The measurements obtained and observations noted only apply to the particular material(s) tested using the specified heat flux, flame distribution, and duration.  
1.5 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units or other units commonly used for thermal testing. If appropriate, round the non-SI units for convenience.  
1.6 This standard does not p...

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