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ASTM F2668-07(2011)

(Practice)

Standard Practice for Determining the Physiological Responses of the Wearer to Protective Clothing Ensembles

Standard Practice for Determining the Physiological Responses of the Wearer to Protective Clothing Ensembles

SIGNIFICANCE AND USE
This practice can be used for the evaluation of the physiological response of a user to protective clothing ensembles worn under controlled conditions.
This practice utilizes a treadmill for the exercise protocol. This method is believed to be appropriate for the evaluation of the majority of protective clothing ensembles, especially where the user will be walking or performing similar activities. In certain situations, where a protective clothing ensemble is designed to be worn where the user is performing specialized functions (for example, sitting or standing with only arm movement), alternate exercise equipment (for example, arm cycle-ergonometer) or exercise protocols should be considered for use in determining the physiological response of the subject.
Where evaluations include the use of Personal Cooling Systems refer to Test Method F2300.
This practice establishes general procedures for the physiological evaluation based on the physiological measurement of core temperature, mean skin temperature, heart rate, exposure time, oxygen consumption, and whole body sweat rate.
The data obtained can be used to evaluate the overall physiological response of the test participant while wearing a protective clothing ensemble.
The data may also be used in the research and development of advanced ensembles that are designed to reduce the physiological strain on the wearer thereby reducing the potential injury (for example, heat injury) associated with wearing the protective clothing ensemble. Workers may be able to wear a protective clothing ensemble for a longer duration due to a reduction in the physiological strain.
The data can also be used to compare similar classes of ensembles and can be used to evaluate protective clothing ensembles as a hazard to the wearer as compared to a baseline ensemble.
In addition, the practice could also be used by consensus standards organizations in the development of physiological test criteria for protective clothing ense...
SCOPE
1.1 This practice specifies the test equipment and procedures for determining the physiological responses of subjects wearing a protective clothing ensemble.
1.2 This practice covers the physiological measurement of internal body core temperature, skin temperature, exposure time, heart rate response, oxygen consumption, and whole body sweat rate, to assess the physiological responses of subjects wearing a protective clothing ensemble. This practice does not measure the musculoskeletal strain on the participant imposed by the protective clothing ensemble.
1.2.1 To increase safety during physiological testing, this dynamic test requires the use of human participants who meet specific health and physical fitness requirements.
1.3 The present standard does not attempt to determine important clothing characteristics, such as thermal insulation and evaporative resistance of the protective clothing ensemble. Test Methods F1291 and F2370 can be used for these clothing measurements.
1.4 The values stated in this practice shall be SI units.
1.5 It is the responsibility of the test laboratory to obtain the necessary and appropriate approval(s) required by their institution for conducting tests using human participants.
1.6 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, and the testing institution, to consult and establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use of this standard.

General Information

Status
Historical
Publication Date
30-Nov-2011
ICS
13.340.10 - Protective clothing
Technical Committee
F23 - Personal Protective Clothing and Equipment
Drafting Committee
F23.60 - Human Factors
Current Stage
Ref Project

Relations

Replaces
ASTM F2668-07 - Standard Practice for Determining the Physiological Responses of the Wearer to Protective Clothing Ensembles
Effective Date
01-Dec-2011
Referred By
ASTM F1154-18 - Standard Practices for Evaluating the Comfort, Fit, Function, and Durability of Protective Ensembles, Ensemble Elements, and Other Components
Effective Date
01-Dec-2011
Referred By
ASTM F1494-23 - Standard Terminology Relating to Protective Clothing
Effective Date
01-Dec-2011

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ASTM F2668-07(2011) - Standard Practice for Determining the Physiological Responses of the Wearer to Protective Clothing EnsemblesASTM F2668-07(2011) - Standard Practice for Determining the Physiological Responses of the Wearer to Protective Clothing Ensembles
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ASTM F2668-07(2011) - Standard Practice for Determining the Physiological Responses of the Wearer to Protective Clothing Ensembles
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2668 − 07 (Reapproved 2011)
Standard Practice for
Determining the Physiological Responses of the Wearer to
1
Protective Clothing Ensembles
This standard is issued under the fixed designation F2668; 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
Protective clothing ensembles such as firefighter turnout gear, HAZMAT suits, and bomb suits may
impose a physiological strain on the wearer. This strain can take the form of heat stress and
cardiovascular and respiratory strain, which can result in injury to the wearer. This practice provides
information on the measurement of the physiological responses of a wearer to a protective clothing
ensemble. The protocol is designed to allow comparisons of the physiological responses of subjects
wearingdifferentprotectiveclothingensemblesofthesametype(forexample,firefighterturnoutgear)
and from different types (for example, firefighter ensemble vs. HAZMAT suit).
1. Scope responsibility of the user, and the testing institution, to consult
and establish appropriate safety and health practices and
1.1 This practice specifies the test equipment and proce-
determine the applicability of regulatory limitations prior to
dures for determining the physiological responses of subjects
use of this standard.
wearing a protective clothing ensemble.
1.2 This practice covers the physiological measurement of 2. Referenced Documents
internal body core temperature, skin temperature, exposure 2
2.1 ASTM Standards:
time, heart rate response, oxygen consumption, and whole
F1291 Test Method for Measuring the Thermal Insulation of
body sweat rate, to assess the physiological responses of
Clothing Using a Heated Manikin
subjects wearing a protective clothing ensemble. This practice
F1494 Terminology Relating to Protective Clothing
does not measure the musculoskeletal strain on the participant
F2300 Test Method for Measuring the Performance of Per-
imposed by the protective clothing ensemble.
sonal Cooling Systems Using Physiological Testing
1.2.1 To increase safety during physiological testing, this
F2370 Test Method for Measuring the Evaporative Resis-
dynamic test requires the use of human participants who meet
tance of Clothing Using a Sweating Manikin
specific health and physical fitness requirements. 3
2.2 Other Standards:
ISO 8996 Ergonomics—Determination of Metabolic Heat
1.3 The present standard does not attempt to determine
important clothing characteristics, such as thermal insulation Production
ISO 9886 Ergonomics—Evaluation of Thermal Strain by
and evaporative resistance of the protective clothing ensemble.
Test Methods F1291 and F2370 can be used for these clothing Physiological Measurements
The Commission for Thermal Physiology of the Interna-
measurements.
tional Union of Physiological Sciences (IUPS Thermal
1.4 The values stated in this practice shall be SI units.
Commission)—Glossary of Terms for Thermal Physiol-
4
1.5 It is the responsibility of the test laboratory to obtain the
ogy
necessary and appropriate approval(s) required by their insti-
tution for conducting tests using human participants. 3. Terminology
1.6 This standard does not purport to address all of the 3.1 Definitions:
safety concerns, if any, associated with its use. It is the
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
1
This practice is under the jurisdiction of ASTM Committee F23 on Personal contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Protective Clothing and Equipment and is the direct responsibility of Subcommittee Standards volume information, refer to the standard’s Document Summary page on
F23.60 on Human Factors. the ASTM website.
3
Current edition approved Dec. 1, 2011. Published March 2012. Originally Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
approved in 2007. Last previous edition approved in 2007 as F2668 - 07. 4th Floor, New York, NY 10036, http://www.ansi.org.
4
DOI:10.1520/F2668-07R11. The Japanese Journal of Physiology, Vol. 51, No. 2, 2001.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2668 − 07 (2011)
3.1.1 acclimation, n—physiological adaptations occurring tion of thermoeffector activities that causes sustained changes
within an organism, which reduce the strain or enhance in the state of non-thermal regulatory systems. Thermal strain
endurance of strain, caused by artificially or experimentally is measurable by an increased heart rate and whole bo
...

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SIGNIFICANCE AND USE
5.1 The purpose of this test method is to provide a measurable criterion of performance about the level of cut resistance provided by different types of protective garments and protected coverings worn by chainsaw operators.  
5.2 This test method is intended to show to what level a protective garment can offer resistance to the cutting action of a chainsaw.  
5.3 The protection which can be demonstrated by the garments and coverings tested in accordance with this test method is achieved by: (1) the cut resistance of the material to cutting when put in contact with saw chain; (2) pulling a part of the material or yarns in the material so that they are drawn into the chain and drive mechanism to block the chain movement; (3) the fibers of the materials used to demonstrate both high resistance to cutting and the capacity to absorb rotational energy, so that chain speed can be slowed down sufficiently to stop the movement of the saw chain; or (4) any combination of these.  
5.4 This test method does not purport to evaluate comfort of lower body protective garments.  
5.5 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.
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1.1 This test method measures cut resistance of garments and devices worn to protect the lower body (legs) 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, it will be decided if this test method will be used to determine one or both of the following: (1) chain speed 50 (CS50), and (2) success/failure (jamming/chain stop or no cut in less than 1.5 s) 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.  
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ASTM F1868-23(Test Method)
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.  
4.2 The thermal interchange between people and their environment is an extremely complicated subject that involves many factors in addition to the steady-state resistance values of fabrics, films, coatings, foams, and leathers, including multi-layer assemblies. Therefore, thermal resistance values, evaporative resistance values, and total heat loss measured on a hot plate may or may not indicate relative merit of a particular material or system for a given clothing application. While a possible indicator of clothing performance, measurements produced by the testing of fabrics have no proven correlation to the performance of clothing systems worn by people. Clothing weight, drape, tightness of fit, and so forth, can minimize or even neutralize the apparent differences between fabrics or fabric assemblies measured by this test method.  
4.3 The thermal resistance and evaporative resistance of clothing systems and items can be measured with a heated sweating manikin in an environmental chamber in accordance with Test Methods F1291, F2370, and F3426.
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1.1 This test method covers the measurement of the thermal resistance, evaporative resistance, and total heat loss under steady-state conditions of fabrics, films, coatings, foams, and leathers, including multi-layer assemblies, for use in clothing systems.  
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1.3 The values in SI units shall be regarded as standard. Other units of measurement are provided in this standard but are not regarded as standard.  
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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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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.
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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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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.  
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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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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 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.
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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.  
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.  
1.9 Fire testing is ...

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ASTM F2053-00(2023)(Guide)
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,  
1.2.2 Challenge particles,  
1.2.3 Test method,  
1.2.4 Test results, and  
1.2.5 Source of the data.  
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.  
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 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.
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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.  
4.3 The thermal interchange between people and their environment is, however, an extremely complicated subject that involves many factors in addition to the steady-state resistance values of fabrics, films, coatings, foams, and leathers, including multi-layer assemblies. Therefore, the cooling provided from liquid evaporation may or may not indicate relative merit of a particular material or system for a given clothing application. While a possible indicator of clothing performance, measurements produced by the testing of fabrics have no proven correlation to the perfo...
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
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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