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ASTM F2588-12(2020)

(Test Method)

Standard Test Method for Man-In-Simulant Test (MIST) for Protective Ensembles

Standard Test Method for Man-In-Simulant Test (MIST) for Protective Ensembles

SIGNIFICANCE AND USE
5.1 This test method is intended to evaluate the penetration and permeation resistance for complete ensembles to vapors from chemical warfare agents and other chemical substances.  
5.1.1 This test method differs from Test Method F1052 by providing an evaluation of ensembles worn on human test subjects and measuring the inward leakage of a chemical agent vapor simulant as it would be absorbed by the wearer’s skin. Test Method F1052 is not applicable to the range of protective ensembles that are evaluated by this test method.  
5.1.2 This test method differs from Test Method F1359/F1359M by using a chemical agent vapor simulant as compared to a liquid challenge and in the use of human test subjects. This test method further provides a quantitative assessment of inward leakage for the chemical agent vapor simulant.  
5.1.3 The use of this test method to determine the inward leakage of other chemical vapor threats must be evaluated on a case-by-case basis.  
5.2 This test method is applied to complete ensembles consisting of a suit or garment in combination with gloves, footwear, respirators, and interface devices.  
5.2.1 This test method permits any combination or configuration of ensemble elements and components, including ensembles where the respirator covers the face or head.  
5.2.2 This test method accommodates protective ensembles or protective clothing having any combination of the following characteristics:
(1) The protective ensemble or clothing is constructed of air-permeable, semipermeable, or impermeable fabrics,
(2) The protective ensemble or clothing is of a single or multi-layered design, or
(3) The protective ensemble or clothing is constructed of inert or sorptive fabrics.  
5.3 MeS has been used as a simulant for chemical warfare agents. MeS is primarily a simulant for distilled mustard (HD) with a similar vapor pressure, density, and water solubility. The use of MeS in vapor form does not simulate all agents or hazardous substances to ...
SCOPE
1.1 This test method specifies the test equipment and procedures for conducting tests to estimate the entry of chemical agent vapor simulant through protective ensembles while worn by test subjects.  
1.2 This test method permits the evaluation of protective ensembles consisting of protective garments or suits, gloves, footwear, respirators, and interface devices.  
1.3 The results of this test method yield local physiological protective dosage factors at individual locations of the human body as well as a systemic physiological protective dosage factor for the entire ensemble.  
1.4 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.  
1.5 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
31-Dec-2019
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 E171/E171M-11(2020) - Standard Practice for Conditioning and Testing Flexible Barrier Packaging
Effective Date
01-May-2020
Referred By
ASTM F1052-20 - Standard Test Method for Pressure Testing Vapor Protective Suits
Effective Date
01-Jan-2020

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ASTM F2588-12(2020) - Standard Test Method for Man-In-Simulant Test (MIST) for Protective EnsemblesASTM F2588-12(2020) - Standard Test Method for Man-In-Simulant Test (MIST) for Protective Ensembles
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ASTM F2588-12(2020) - Standard Test Method for Man-In-Simulant Test (MIST) for Protective Ensembles
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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: F2588 − 12 (Reapproved 2020)
Standard Test Method for
1
Man-In-Simulant Test (MIST) for Protective Ensembles
This standard is issued under the fixed designation F2588; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope F1359/F1359MTest Method for Liquid Penetration Resis-
tance of Protective Clothing or Protective Ensembles
1.1 This test method specifies the test equipment and
Under a Shower Spray While on a Manikin
procedures for conducting tests to estimate the entry of
F1494Terminology Relating to Protective Clothing
chemical agent vapor simulant through protective ensembles
F1731Practice for Body Measurements and Sizing of Fire
while worn by test subjects.
andRescueServicesUniformsandOtherThermalHazard
1.2 This test method permits the evaluation of protective
Protective Clothing
ensembles consisting of protective garments or suits, gloves,
2.2 National Fire Protection Association (NFPA) Stan-
footwear, respirators, and interface devices.
3
dards:
1.3 The results of this test method yield local physiological
NFPA1971StandardonProtectiveEnsemblesforStructural
protective dosage factors at individual locations of the human
and Proximity Fire Fighting
body as well as a systemic physiological protective dosage
NFPA 1994Standard on Protective Ensembles for CBRN
factor for the entire ensemble.
Terrorism Incidents
1.4 This standard does not purport to address all of the 4
2.3 U.S. Military Publication:
safety concerns, if any, associated with its use. It is the
Test Operations Procedure (TOP 10-2-022)Man-In-Simu-
responsibility of the user of this standard to establish appro-
lant Test (MIST)—Chemical Vapor Testing of Chemical/
priate safety, health, and environmental practices and deter-
Biological Protective Suits, September 2001
mine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accor-
3. Terminology
dance with internationally recognized principles on standard-
3.1 Definitions:
ization established in the Decision on Principles for the
3.1.1 chemicalagentvaporsimulant,n—asubstanceusedto
Development of International Standards, Guides and Recom-
replicate vapor characteristics of a chemical agent which is a
mendations issued by the World Trade Organization Technical
more toxic substance.
Barriers to Trade (TBT) Committee.
3.1.1.1 Discussion—In this test method, methyl salicylate is
used as a chemical agent vapor simulant for the blister agent,
2. Referenced Documents
distilled mustard.
2
2.1 ASTM Standards:
3.1.2 chemical terrorism agent, n—a liquid, solid, gaseous,
E171/E171MPractice for Conditioning andTesting Flexible
or vapor chemical warfare agent or a toxic industrial chemical
Barrier Packaging
usedtoinflictlethalorincapacitatingcasualties,generallyona
F1052Test Method for Pressure Testing Vapor Protective
civilian population as a result of a terrorist attack.
Suits
F1154Practices for Evaluating the Comfort, Fit, Function,
3.1.3 interface area, n—alocationonthebodywheretwoor
and Durability of Protective Ensembles, Ensemble
more protective clothing items (for example, suits, garments,
Elements, and Other Components
hoods, gloves, footwear, respirators, or other items) come into
contact.
3.1.3.1 Discussion—Interfaces are potential breaches that
1
ThistestmethodisunderthejurisdictionofASTMCommitteeF23onPersonal
could allow entry of chemicals into the interior of the protec-
ProtectiveClothingandEquipmentandisthedirectresponsibilityofSubcommittee
tive ensemble.
F23.30 on Chemicals.
Current edition approved Jan. 1, 2020. Published January 2020. Originally
approved in 2006. Last previous edition approved in 2012 as F2588–12. DOI:
10.1520/F2588-12R20.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from National Fire Protection Association (NFPA), 1 Batterymarch
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Park, Quincy, MA 02169-7471, http://www.nfpa.org.
4
Standards volume information, refer to the standard’s Document Summary page on U.S. Army Developmental Test Command (DTC), ATTN: CSTE-DTC-TT-S,
the ASTM website. Aberdeen Proving Ground, MD 21005-5055.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2588 − 12 (2020)
3.1.4 interface device, n—an item of the ensemble that is 5. Signi
...

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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.  
1.3 This specification does not address protective clothing used for surgical applications, such as surgical gowns or decontamination gowns; protective clothing for the hands, such as surgical gloves, patient examination gloves, or other medical gloves; protective clothing for the head, such as goggles or face shields, surgical caps or hoods, surgical masks, or respirators; protective clothing for the feet, such as operating room shoes, shoe covers, or surgical boots; or other types of protective clothing and equipment worn by healthcare providers.  
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Standard Test Method for Evaluation of Flame-Resistant Clothing for Protection Against Fire Simulations Using an Instrumented Manikin

SIGNIFICANCE AND USE
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).  
5.1.1 This test method does not simulate high radiant exposures, for example, those found in electric arc flash exposures, some types of fire exposures where liquid or solid fuels are involved, nor exposure to nuclear explosions.  
5.2 This test method provides a measurement of garment and clothing ensemble performance on a stationary upright manikin of specified dimensions. This test method is used to provide predicted skin burn injury for a specific garment or protective clothing ensemble when exposed to a laboratory simulation of a fire. It does not establish a pass/fail for material performance.  
5.2.1 This test method is not intended to be a quality assurance test. The results do not constitute a material’s performance specification.  
5.2.2 The effects of body position and movement are not addressed in this test method.  
5.3 The measurement of the thermal protection provided by clothing is complex and dependent on the apparatus and techniques used. It is not practical in a test method of this scope to establish details sufficient to cover all contingencies. Departures from the instructions in this test method have the potential to lead to significantly different test results. Technical knowledge concerning the theory of heat transfer and testing practices is needed to evaluate if, and which departures from the instructions given in this test method are significant. Standardization of the test method reduces, but does not eliminate, the need for such technical knowledge. Report any departures along with the results.
SCOPE
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.  
1.2 The visual and physical changes to the single-layer garment or protective clothing ensemble are recorded to aid in understanding the overall performance of the garment or protective clothing ensemble and how the predicted human skin burn injury results can be interpreted.  
1.3 The skin burn injury prediction is based on a limited number of experiments where the forearms of human subjects were exposed to elevated thermal conditions. This forearm information for skin burn injury is applied uniformly to the entire body of the manikin, except the hands and feet. The hands and feet are not included in the skin burn injury prediction.  
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.  
1.5 This standard is used to measure and describe the response of materials, products, or assemblies to heat and flame 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.  
1.6 This method is not a fire test response test method.  
1.7 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.  
1.8 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.  
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ASTM F2407/F2407M-23a(Specification)
Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities

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.  
4.2 This specification does not address protective clothing used for nonsurgical applications, such as isolation gowns or decontamination gowns; protective clothing for the hands, such as surgical gloves, patient examination gloves, or other medical gloves; protective clothing for the head, such as goggles or face shields, surgical caps or hoods, surgical masks, or respirators; protective clothing for the feet, such as operating room shoes, shoe covers, or surgical boots; or other types of protective clothing and equipment worn by healthcare providers.  
4.3 Surgical gowns are either multiple-use or single-use products as designated by the manufacturer. This specification is intended to provide the basis for manufacturer claims for surgical gown performance and efficacy. For multiple-use gowns, this specification takes into account the anticipated care and maintenance of these products by examining test requirements for surgical gown materials both before and after the maximum expected number of cycles for laundering and sterilization.  
4.4 Additional information on the processing of multiple-use surgical gowns is provided in ANSI/AAMI ST65.  
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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.
Note 1: Some properties require minimum performance and others are for documentation only.
Note 2: ANSI/AAMI PB70 evaluates the barrier properties of surgical gown fabrics using water only in Levels 1, 2, and 3. Since surgical gowns are exposed to blood and other fluids with different surface tensions, the performance of additional testing to identify the barrier levels to simulated biological fluids is required for a Level 4 gown.  
1.2 This specification does not cover all the requirements that a healthcare facility deems necessary to select a product, nor does it address criteria for evaluating experimental products.  
1.3 This specification is not intended to serve as a detailed manufacturing or purchase...

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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.  
4.1.1 The thermal resistance, evaporative resistance, and total heat loss can be significantly affected by environmental conditions. Extreme care must be taken when using results measured under standard testing conditions to determine a material’s suitability for use in conditions outside the testing conditions.  
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Standard Guide for Evaluating Chemical Protective Clothing

SIGNIFICANCE AND USE
4.1 The standards under the jurisdiction of Committee F23 and other technical committees can be used individually or as part of an integrated protocol in the development, selection, specification, and use of chemical protective clothing.  
4.2 The standards are intended as a means by which information can be requested, generated, and reported in a consistent, comparable manner.  
4.3 The suggested evaluation and test methods are recommended guidelines only. Test methods offer procedures for evaluating chemical protective clothing at standardized conditions to allow comparison.  
4.4 The information on clothing performance must be combined with professional judgment and a clear understanding of the clothing application to provide the best protection to the worker. All chemical protective clothing use must be based on a hazard assessment to determine the risks for exposure to chemicals and other hazards. Conduct hazard assessments in accordance with 29 CFR 1910.132.  
4.5 Chemical protective clothing intended for use during hazardous materials emergencies shall be evaluated against and conform to NFPA 1991, Standard on Vapor-Protective Ensemble for Hazardous Materials Emergencies, or NFPA 1992, Standard on Liquid Splash-Protective Ensemble and Clothing for Hazardous Materials Emergencies, as appropriate for the type of emergency. For emergencies involving release of chemical agents during terrorism incidents, chemical protective clothing shall be evaluated against and conform to NFPA 1994, Standard on Protective Ensemble for Chemical/Biological Terrorism Incidents.  
4.6 Recommendations for labeling chemical protective clothing are provided in Practice F1301, recommendations for implementing a chemical protective clothing program are provided in Practice F1461, and recommendations for preparing care and maintenance instructions are provided in Practice F2061.  
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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.  
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Standard Guide for Documenting the Results of Airborne Particle Penetration Testing of Protective Clothing Materials

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.
SCOPE
1.1 This guide provides a format for documenting information and performance data for an airborne particle penetration test.  
1.2 Documented data and information are grouped into five categories that define important aspects of each test:  
1.2.1 Description of material tested,  
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1.3 Use of this guide is facilitated by adherence to procedures outlined in a standard test method.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurements are included in this standard.  
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ASTM F2992-23(Test Method)
Standard Test Method for Measuring Cut Resistance of Materials Used in Protective Clothing with Tomodynamometer Test Equipment

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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ASTM F3628-23(Test Method)
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.  
1.4 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.  
1.5 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 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 F3267-22(Specification)
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...

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