ASTM F3267-22

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

Relations

• Refers: ASTM E96/E96M-24 - Standard Test Methods for Gravimetric Determination of Water Vapor Transmission Rate of Materials
• Effective Date: 01-Mar-2024
• Refers: ASTM D5587-15(2024) - Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
• Effective Date: 01-Jan-2024
• Refers: ASTM E96/E96M-23 - Standard Test Methods for Gravimetric Determination of Water Vapor Transmission Rate of Materials
• Effective Date: 15-Nov-2023
• 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
• Refers: ASTM D1776/D1776M-20 - Standard Practice for Conditioning and Testing Textiles
• Effective Date: 01-Feb-2020
• Refers: ASTM D5587-15(2019) - Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
• Effective Date: 01-Jul-2019
• Refers: ASTM F2061-17 - Standard Practice for Chemical Protective Clothing: Wearing, Care, and Maintenance Instructions
• Effective Date: 01-Nov-2017
• Refers: ASTM D1683/D1683M-17e1 - Standard Test Method for Failure in Sewn Seams of Woven Fabrics
• Effective Date: 01-Mar-2017
• Refers: ASTM D1683/D1683M-17 - Standard Test Method for Failure in Sewn Seams of Woven Fabrics
• Effective Date: 01-Mar-2017
• Refers: ASTM D1683/D1683M-16 - Standard Test Method for Failure in Sewn Seams of Woven Fabrics
• Effective Date: 01-Nov-2016
• Refers: ASTM D3787-16 - Standard Test Method for Bursting Strength of Textiles—Constant-Rate-of-Traverse (CRT) Ball Burst Test
• Effective Date: 01-Jan-2016
• Refers: ASTM D1776/D1776M-16 - Standard Practice for Conditioning and Testing Textiles
• Effective Date: 01-Jan-2016
• Refers: ASTM D3787-15 - Standard Test Method for Bursting Strength of Textiles—Constant-Rate-of-Traverse (CRT) Ball Burst Test
• Effective Date: 01-Jul-2015
• Refers: ASTM D5587-15 - Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
• Effective Date: 01-Jul-2015
• Refers: ASTM E96/E96M-15 - Standard Test Methods for Water Vapor Transmission of Materials
• Effective Date: 01-May-2015

Overview

ASTM F3267-22: Standard Specification for Protective Clothing for Use Against Liquid Chemotherapy and Other Liquid Hazardous Drugs outlines essential design, performance, documentation, and labeling requirements for protective clothing intended to shield workers from liquid chemotherapy agents and other hazardous drug exposures. Developed by ASTM International, this standard establishes permeation resistance testing for both barrier materials and seams of protective garments, ensuring minimum protection standards are met. The specification supports manufacturers and end-users in evaluating, selecting, and labeling garments for use in healthcare, pharmaceutical compounding, and related environments.

Key Topics

• Permeation Resistance Testing

  • Requires barrier materials and seams to undergo permeation resistance tests using a standardized battery of seven chemotherapy drugs.
  • Two compliance levels defined:
    • Broad protection: breakthrough detection times of 30 minutes or more for all seven drugs.
    • Selective protection: 30 minutes or more for at least five of the seven drugs.

• Labeling and Documentation

  • Provides clear labeling requirements to distinguish between broad and selective protection levels.
  • Allows additional reporting for protective performance against other hazardous liquids as determined by the needs of manufacturers or end-user organizations.

• Design and Performance Criteria

  • Stipulates minimum flammability requirements.
  • Includes criteria for biocompatibility and sterility assurance if the product is marketed as a medical device or supplied sterile.
  • Sets out optional reporting of physical properties such as strength, durability, and breathability.
  • Requires that medical device garments (e.g., surgical and isolation gowns) also comply with applicable standards like AAMI PB70 and ASTM F2407/F3352.

• Intended Use and Limitations

  • Covers single-use full-body and partial-body protective clothing, including gowns, coveralls, aprons, sleeve protectors, and footwear covers.
  • Does not address protection from chemotherapy drugs in vapor or aerosol form, nor does it provide criteria for respiratory protective devices.
  • Selection and maintenance guidelines must be referenced from USP 800 for hazardous drug handling.

Applications

The ASTM F3267-22 standard is highly relevant for:

• Healthcare Facilities

  • Protects healthcare workers during drug preparation, compounding, administration, and patient care involving liquid chemotherapy agents.
  • Supports infection control and hazardous exposure mitigation in oncology units, pharmacies, and clinics.

• Pharmaceutical Compounding

  • Supplies guidelines for personnel handling, transferring, or transporting liquid hazardous drugs.
  • Ensures safety in environments where accidental splashes or spills are possible.

• Design and Manufacturing

  • Provides manufacturers with standardized test methods and criteria for making validated protection claims about their protective clothing products.
  • Enables objective comparison between different protective garments based on laboratory-tested data.

• Regulatory Compliance

  • Assists organizations in meeting the hazardous drug containment requirements set out in USP 800 and relevant OSHA guidelines.
  • Streamlines procurement and risk assessment processes by clarifying minimum protection benchmarks.

Related Standards

For comprehensive workplace safety and product compliance, ASTM F3267-22 references and aligns with several related standards and guidelines, including:

• AAMI PB70: Liquid barrier performance and classification for protective apparel and drapes.
• ASTM F2407 / F3352: Specifications specifically for surgical and isolation gowns.
• ASTM D6978: Assessment of resistance of medical gloves to permeation by chemotherapy drugs.
• ISO 10993: Biocompatibility evaluation of medical devices.
• NFPA 1999: Standards for emergency medical protective clothing.
• USP 800: Hazardous Drugs-Handling in Healthcare Settings.

Looking for compliant, high-quality protective clothing against liquid hazardous drugs? Make sure your products align with the latest requirements in ASTM F3267-22 for reliable worker safety and regulatory assurance.

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:F3267 −22
Standard Specification for
Protective Clothing for Use Against Liquid Chemotherapy
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
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.
priate safety, health, and environmental practices and deter-
Current edition approved Dec. 1, 2022. Published December 2022. DOI:
10.1520/F3267-22. mine the applicability of regulatory limitations prior to use.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F3267−22
1.8 This international standard was developed in accor- 2.3 ANSI/ASQ Standards:
dance with internationally recognized principles on standard- ANSI/ASQ Z1.4 Sampling Procedures and Tables for In-
ization established in the Decision on Principles for the spection by Attributes
Development of International Standards, Guides and Recom- ANSI/ASQ Z1.9 Sampling Procedures and Tables for In-
mendations issued by the World Trade Organization Technical spection by Variables for Percent Nonconforming
Barriers to Trade (TBT) Committee. 2.4 Federal Standards:
16 CFR 1610 Standard for the Flammability of Clothing
2. Referenced Documents
Textiles, Federal Register, Vol 40, No. 59891, Dec. 30,
2.1 ASTM Standards:
21 CFR Part 801 Labeling, Federal Register, Vol 41, No.
D751 Test Methods for Coated Fabrics
6896, Feb. 13, 1976
D1683/D1683M Test Method for Failure in Sewn Seams of
21 CFR Part 801.437 User Labeling for Devices That
Woven Fabrics
Contain Natural Rubber, Federal Register, Vol 62, No.
D1776/D1776M Practice for Conditioning and Testing Tex-
64029, Sept. 30, 1997, as amended in Vol 63, No. 46175,
tiles
Aug. 31, 1998
D3786/D3786M Test Method for Bursting Strength of Tex-
2.5 INDA Standard:
tile Fabrics—Diaphragm Bursting StrengthTester Method
WSP 70.4 Water Vapor Transmission Rate—Mocon Method
D3787 Test Method for Bursting Strength of Textiles—
2.6 ISO Standards:
Constant-Rate-of-Traverse (CRT) Ball Burst Test
ISO 2859-1 Sampling Plans for Inspection by Attributes
D5034 TestMethodforBreakingStrengthandElongationof
ISO 3951 Sampling Procedures and Charts for Inspection by
Textile Fabrics (Grab Test)
Variables for Percent Nonconforming
D5587 Test Method for Tearing Strength of Fabrics by
ISO 11134 Sterilization of Health Care Products—
Trapezoid Procedure
Requirements for Validation and Routine Control—
D6701 Test Method for Determining Water Vapor Transmis-
Industrial Moist Heat Sterilization
sion Rates Through Nonwoven and Plastic Barriers
ISO 11135 Medical Devices—Validation and Routine Con-
D6978 Practice for Assessment of Resistance of Medical
trol of Ethylene Oxide Sterilization
Gloves to Permeation by Chemotherapy Drugs
ISO 11137 Sterilization of Health Care Products—
E96/E96M Test Methods for Gravimetric Determination of
Requirements for Validation and Routine Control—
Water Vapor Transmission Rate of Materials
Radiation Sterilization
F739 Test Method for Permeation of Liquids and Gases
ISO 13683 Sterilization of Health Care Products—
Through Protective Clothing Materials Under Conditions
RequirementsforValidationandRoutineControlofMoist
of Continuous Contact
Heat Sterilization in Health Care Facilities
F1494 Terminology Relating to Protective Clothing
2.7 NIOSH Document:
F1868 Test Method for Thermal and Evaporative Resistance
Publication No. 2016-161 List of Antineoplastic and Other
of Clothing Materials Using a Sweating Hot Plate
Hazardous Drugs in Healthcare Settings
F2061 Practice for Chemical Protective Clothing: Wearing,
2.8 NFPA Standard:
Care, and Maintenance Instructions
NFPA1999:2018 Standard on Protective Clothing for Emer-
F2407/F2407M Specification for Surgical Gowns Intended
gency Medical Operations
for Use in Healthcare Facilities
2.9 U.S. Pharmacopeia:
F3352/F3352M Specification for Isolation Gowns Intended
USP 800 Hazardous Drugs—Handling in Healthcare Set-
for Use in Healthcare Facilities
tings
2.2 AAMI Documents:
AAMI PB70:2012 Liquid Barrier Performance and Classifi-
3. Terminology
cation of ProtectiveApparel and Drapes Intended for Use
3.1 Definitions:
in Health Care Facilities
3.1.1 analytical technique, n—a procedure whereby the
ISO 10993-5:2021 Biological Evaluation of Medical
concentration of the test chemical in a collection medium is
Devices—Part 5: Tests for in Vitro Cytotoxicity
quantitatively measured.
ISO 10993-10:2021 Biological Evaluation of Medical
Devices—Part 10: Tests for Irritation and Skin Sensitiza-
tion
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036, http://www.ansi.org.
ISO 10993-23:2021 Biological Evaluation of Medical
Available from U.S. Government Publishing Office (GPO), 732 N. Capitol St.,
Devices—Part 23: Tests for Irritation
NW, Washington, DC 20401, http://www.gpo.gov.
Available from Association of the Nonwoven Fabrics Industry (INDA), 1100
Crescent Green, Suite 115, Cary, NC 27518, http://www.inda.org.
2 7
For referenced ASTM standards, visit the ASTM website, www.astm.org, or AvailablefromNationalInstituteforOccupationalSafetyandHealth(NIOSH),
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Patriots Plaza 1, 395 E Street, SW, Suite 9200, Washington, DC 20201. https://
Standards volume information, refer to the standard’s Document Summary page on www.cdc.gov/niosh/docs/2016-161/default.html.
the ASTM website. Available from National Fire Protection Association (NFPA), 1 Batterymarch
Available from Association for the Advancement of Medical Instrumentation Park, Quincy, MA 02169-7471, http://www.nfpa.org.
(AAMI), 901 N. Glebe Road, Suite 300, Arlington, VA 22203-1633, http:// Available from U.S. Pharmacopeial Convention (USP), 12601 Twinbrook
www.aami.org. Pkwy., Rockville, MD 20852-1790, http://www.usp.org.
F3267−22
3.1.1.1 Discussion—In this specification, the analytical 3.1.8 test chemical, n—solid, liquid, gas, or mixture thereof
technique is specified by the manufacturer, supplier, a used to evaluate the performance of a protective clothing
pharmacy, or a clinical specifier of the chemotherapy drug or material.
hazardous drug, or demonstrated by the testing laboratory
3.1.8.1 Discussion—In this specification, the test chemical
when using a scientifically sound, validated analytical tech-
is a liquid chemotherapy or other liquid hazardous drug that is
nique.
mixed with a solvent, a co-solvent, and additives as provided
for clinical use.
3.1.2 barrier material, n—the layer of the protective cloth-
ing item that protects against the potential hazard or that serves 3.1.9 validated statistical rationale, n—the requirement for
to isolate the external environment from contamination by the an objective cause or reason to be stated why the initial test or
wearer of the clothing. results are considered incorrect.
3.1.2.1 Discussion—In some protective clothing designs, a
3.2 For definitions of other protective clothing-related terms
composite of different material layers is used. For the purpose
used in this specification, refer to Terminology F1494.
of this specification, if the composite can be separated without
damaging or compromising the individual layers, then only the
4. Significance and Use
material layer or layers that provides the actual permeation
4.1 The purpose of this specification is to establish the
resistance against liquid chemotherapy or other liquid hazard-
barrierperformancepropertiesofmaterialsandseamsinvolved
ous drugs is tested. If the clothing item being tested involves a
in the construction of protective clothing used for protection
seam of barrier materials, then the full seam construction
against liquid chemotherapy and other liquid hazardous drugs.
providing the barrier performance is tested.
This specification also sets requirements for other areas of
3.1.3 breakthroughdetectiontime,n—theelapsedtimemea-
protectiveclothingperformance,theoptionaldocumentationof
sured from the start of the test to the sampling time that
material performance properties related to the intended use of
immediately precedes the sampling time at which the test
chemotherapy protective clothing, protective clothing design
chemical (drug) is first detected.
and labeling, and the provision of user information and
3.1.3.1 Discussion—In this specification, the specified
technical information.
breakthrough detection time is when the permeation rate is
4.1.1 The protective clothing selected for use must be
0.1 µg⁄cm min.
selected based on an assessment of the potential exposure
hazards involved in the handling of liquid chemotherapy and
3.1.4 chemotherapy drug, n—a drug that controls or kills
other liquid hazardous drugs. USP 800, Hazardous Drugs—
neoplasticcells,whichistypicallyusedinchemotherapytokill
Handling In Healthcare Settings, provides specific recommen-
cancer cells.
dations for the types of personal protective equipment (PPE) to
3.1.4.1 Discussion—For this specification, only protection
be used in different types of handling and operations involving
fromtheliquidformofchemotherapydrugsorotherhazardous
liquid chemotherapy and other liquid hazardous drugs for
drugs is assessed.
healthcare.
3.1.5 collection medium, n—a liquid, gas, or solid that
4.1.2 It is recognized that individuals involved in the
absorbs,adsorbs,dissolves,suspends,orotherwisecapturesthe
manufacturing, transport, packaging, compounding,
test chemical (drug) and does not affect the measured perme-
preparation, and administration of liquid chemotherapy and
ation.
other liquid hazardous drugs are exposed to these drugs in
3.1.5.1 Discussion—In this specification, a liquid collection different concentrations, volumes, and exposure conditions. In
medium is used. In some cases, the collection medium can be
this specification, protective clothing is evaluated against
thedrugvehicleinwhichthechemotherapydrugismixed(one liquid chemotherapy and other liquid hazardous drugs at the
or more solvents) while in other cases, it can be either distilled concentration for which the drug is typically prepared for
water or a solvating medium that is the least harmful to the clinical use.
clothing fabric/seam subject to testing.
4.2 For uniformity of demonstrating claims against this
3.1.6 hazardous drug, n—a drug with at least one of the specification under Part A labeling requirements, seven indi-
following six characteristics: carcinogenicity, teratogenicity, vidual chemotherapy drugs are specified for permeation testing
reproductive toxicity, genotoxicity, organ toxicity at low doses, that represent a range of drug formulations, molecular
and drugs that mimic existing drugs in structure or toxicity. structures, and typical material permeation resistance charac-
teristics associated with protective clothing.
3.1.7 protective clothing, n—an item of clothing that is
4.2.1 It is also permissible to represent protective clothing
specifically designed and constructed for the intended purpose
permeation against specific liquid chemotherapy and other
of isolating all or part of the body from a potential hazard; or,
hazardous drugs for meeting Part B labeling requirements.
isolating the external environment from contamination by the
wearer of the clothing.
4.3 The specific test procedures applied for the measure-
3.1.7.1 Discussion—In this specification, the potential haz- ment of protective clothing material and seam permeation
ard is exposure to liquid chemotherapy drugs or other liquid resistance are based on procedures established in Test Method
hazardousdrugsbypermeationofprotectiveclothingmaterials F739 as modified in this specification. These procedures
and seams used in garments. includespecificsamplingtimesfordeterminingthepermeation
F3267−22
TABLE 2 Sample List of Additional Chemotherapy Drugs and
resistance of protective clothing material and seam specimens
Their Concentrations as Typically Prepared for Clinical Use
and reporting of specific test results.
Concentration
4.3.1 Practice D6978, which specifies procedures for the
Chemotherapy Drug Collection Medium
A
(mg/mL)
evaluation of medical glove permeation by chemotherapy
Bleomycin sulfate 15.0 Distilled water
drugs, also specifies the use of Test Method F739 but uses a
Carboplatin 10.0 Distilled water
Cisplatin 1.0 Distilled water
more rigorous criterion for establishing breakthrough detection
Cytarabine HCl 100.0 Distilled water
time at a permeation rate of 0.01 µg/cm min.
Dacarbazine 10.0 Distilled water
4.3.2 A permeation rate of 0.1 µg⁄cm min is used for this Daunorubicin HCl 5.0 Distilled water
Docetaxel 10.0 Distilled water
specification because in most cases, there is less intimate
Gemcitabine 38.0 Distilled water
contact of the clothing with the wearer’s skin as there is for
Idarubicin 1.0 Distilled water
examination gloves, which are close fitting to the hands. Ifosfamide 50.0 Distilled water
Irinotecan 20.0 Distilled water
Moreover, if splashed or contacted with liquid chemotherapy
Mechlorethamine HCl 1.0 Distilled water
orotherdangerousdrugs,clothingismorelikelytoberemoved
Melphalan 5.0 Distilled water
and changed. Methotrexate 25.0 Distilled water
Mitomycin 0.5 Distilled water
4.3.3 Requirements in this standard also require reporting
Mitoxantrone 2.0 Distilled water
the amount (µg/cm ) of cumulative permeation at 30, 60, and
Vincristine sulfate 1.0 Distilled water
240 min, to enable an understanding for the amount of chemi-
A
Initial reconstitution or commercially available concentration.
cal (drug) that permeates a given area of material for compari-
son purposes. Cumulative permeation is not used for establish-
ing conformity with this specification.
five of the seven required liquid chemotherapy drugs from
4.4 This specification requires the protective clothing mate-
Table 1 that are specified for testing.
rialandseamsbetestedforpermeationresistanceagainstseven
4.5.3 When this specification is applied to other liquid
common chemotherapy drug formulations, which are listed in
chemotherapy drugs or other liquid hazardous drugs, the
Table1,tomeetPartAlabelingrequirements.Anadditionallist
barrier materials and seams are required to demonstrate a
of 17 chemotherapy drugs is provided in Table 2 to which
normalized breakthrough detection time of at least 30 min for
protective clothing materials and seams can also be tested that
each additional drug tested.
can be evaluated to meet Part B labeling requirements. These
4.6 This specification is based on the use of protective
lists are the same as those specified in Practice D6978.In
clothing for a single use only as recommended by USP 800.
addition to the list of specific chemotherapy drugs in Tables 1
NOTE 1—It is recognized that reusable protective clothing could be
and 2 of this standard, this specification is also intended to
specified for certain liquid chemotherapy drugs or other liquid hazardous
address additional liquid chemotherapy or other liquid hazard-
drugs when the specific risks for reuse have been investigated and
ousdrugsthatareusedinhealthcareandrelatedindustries.The
accountedfor.Whilespecificrequirementsforreusableprotectiveclothing
NationalInstituteforOccupationalSafetyandHealthpublishes
use against liquid chemotherapy drugs and other liquid hazardous drugs
a list of antineoplastic and other hazardous drugs in healthcare are not addressed in this standard, particularly for use in healthcare, any
representation of such products for multiple use would need to consider
settings in DHHS (NIOSH) Publication No. 2016-161.
the effectiveness of decontamination techniques for removing residual
4.5 For the purposes of this specification, three different
drug contamination and the impact of the repeated cleaning and decon-
levels of liquid chemotherapy drug protective performance are tamination on the barrier performance and other properties of the product.
established.
4.7 The types of protective clothing covered by this speci-
4.5.1 Broad chemotherapy drug protection pertains to pro-
fication include, but are not limited to, full-body clothing such
tective clothing that has barrier materials and seams with a
asgownsorcoverallsandpartial-bodyclothingsuchasaprons,
normalizedbreakthroughtimeofatleast30 minforeachofthe
sleeved aprons, sleeve protectors, and footwear covers used in
sevenrequiredliquidchemotherapydrugsfromTable1thatare
any manufacturing, transport, or in healthcare settings such as
specified for testing.
for patient care. Some design requirements are included to
4.5.2 Selective chemotherapy drug protection pertains to
ensure complete barrier protection to the portions of the body
protective clothing that has barrier materials and seams with a
covered by the protective clothing item.
normalized breakthrough time of at least 30 min for at least
4.8 Specific design criteria have been included in this
specification to address attributes of the protective clothing to
TABLE 1 List of Required Chemotherapy Drugs and Their
ensure consistent barrier protection to the portions of the body
Concentrations as Typically Prepared for Clinical Use
that are covered by the protective clothing item. These criteria
Concentration
are primarily based on design criteria found in USP 800 and
Chemotherapy Drug Collection Medium
A
(mg/mL)
NFPA1999 for protective clothing used in emergency medical
Carmustine 3.3 10 % ethanol (aq.)
Cyclophosphamide 20.0 Distilled water operations.
Doxorubicin HCl (Adriamycin) 2.0 Distilled water
Etoposide 20.0 Distilled water NOTE 2—It is recommended that end users consult the regulatory
Fluorouracil (Adrucil) 50.0 9.20 pH NaOH sol’n guidance appropriate for this protective clothing to determine if selected
Paclitaxel (Taxol) 6.0 30 % methanol (aq.)
protective clothing meets applicable requirements. Not all protective
Thio TEPA 10.0 Distilled water
clothing can be represented against this standard as appropriate for all
A
applications, particularly for those organizations that choose to comply
Initial reconstitution or commercially available concentration.
with USP 800. For example, protective clothing configured as coveralls
F3267−22
used by non-medical personnel with a front zipper do not meet USP 800 gowns and isolation gowns at a specified Acceptable Quality Level
criteria. (AQL). In contrast, this specification does not rely on permeation
resistance using an established AQL, but rather requires testing three
4.9 Performancecriteriaareestablishedforprotectivecloth-
specimens for permeation resistance against each chemotherapy or other
ing material flammability; for biocompatibility for protective
drug that is evaluated for each barrier material and type of seam in the
clothing where the protective clothing is intended for use as
protectiveclothingitem.AQL-basedperformanceisnotestablishedinthis
specification.
medical devices, such as surgical gowns or isolation gowns;
and for sterility assurance, if protective clothing items are
6. Design Requirements
provided in a sterile condition.
6.1 Protective clothing shall be permitted to be configured
4.10 The testing of protective clothing materials and seams
as full-body garments such as gowns or coveralls, and non-
for a number of performance properties related to strength,
full-body garments such as aprons, sleeve protectors, and
durability, or breathability is optional and for documentation
sleeved aprons or smocks.
purposes only.The purpose of these test results is to aid an end
6.1.1 Where garments are configured as aprons or smocks,
user in the comparison of product performance relative to its
garments shall be designed to protect the front torso of the
intended use and other hazards that may be present.
wearer from the neck to below the knees.
4.11 Where protective clothing is intended for use as a
6.1.2 Where garments are configured as sleeve protectors,
surgical or isolation gown, requirements are provided that the
garments shall be designed to protect the arm of the wearer
clothing item also meet AAMI PB70, Specification F2407/
from the wrist crease to a distance of no less than 405 mm
F2407M, or Specification F3352/F3352M, as applicable to the
[16 in.] from the wrist crease.The wrist crease is shown in Fig.
clothing item.
1.
6.1.3 Where garments are configured as sleeved aprons,
5. General Requirements
garments shall be designed to protect the front torso of the
5.1 All protective clothing items evaluated against this
wearer from the neck to below the knees and arms of the
specificationarerequiredtomeettheapplicabledesignrequire-
wearer and from the wearer’s shoulder to the wrist crease.
ments specified in Section 6, performance requirements speci-
6.1.4 Where garments are configured as gowns, the gowns
fied in Section 7, documentation requirements specified in
shallhavenoopeningsinthefront,havelongsleeves,andhave
Section 8, if elected by the manufacturer, applicable labeling
closures positioned in the back. The protective fabric shall
requirementsspecifiedinSection12,andtechnicalinformation
wrap around the torso and overlap by at least 100 mm [4 in.] at
requirements specified in Section 14.
all points on the wearer’s back. The back of the garment shall
5.2 If the protective clothing item is also intended for use as extend from within 100 mm [4 in.] of the nape of the neck to
a surgical gown or isolation gown, test and classify the barrier the hemline.
performance of the protective clothing materials and seams as
6.2 Protective clothing items with sleeves shall have close
specifiedinAAMIPB70,andtheprotectiveclothingshallmeet
or tight-fitting cuffs.
Specification F2407/F2407M for surgical gowns and Specifi-
NOTE 5—Knit cuffs by themselves do not offer any protection from
cation F3352/F3352M for isolation gowns.
exposure to liquids, including liquid chemotherapy and other liquid
NOTE 3—The classification of protective clothing to AAMI PB70 does hazardous drugs. It is advised that protective clothing having sleeves with
knit cuffs include instructions as part of the required user information
not confer any specific performance against liquid chemotherapy and
other liquid hazardous drugs. (Section13)thatrequirethattheknitcuffbecoveredwithachemotherapy
NOTE 4—AAMI PB70 establishes the barrier performance of surgical glove that has been evaluated in accordance with Practice D6978, or other
FIG. 1Location of Wrist Crease
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means to prevent direct exposure of the knit material to liquid chemo- NOTE 7—Additional chemotherapy drugs for consideration are pro-
therapy or other liquid hazardous drugs. vided in Table 2.
6.3 Where garments are configured as coveralls, the cover- 7.2 Flame Spread:
alls shall include a protective flap over the front positioned 7.2.1 Materials used in the construction of protective cloth-
zipper or other closure that can be temporarily secured to ing shall meet the requirements for Class 1 “normal flamma-
protect any liquid exposure to the garment closure. bility” in accordance with 16 CFR Part 1610.
6.4 Protective clothing items shall be permitted to include 7.3 Biocompatibility:
integratedsockstoprotectthewearer’sfeetinconjunctionwith 7.3.1 If represented by the manufacturer as being suitable
outer footwear. foruseforpatientcontactinamedicaldevicesetting,materials
6.4.1 Whereprotectiveclothingitemsincorporatesocks,the used in the construction of protective clothing items shall meet
socks shall be designed as an extension of the garment leg and the biocompatibility requirements as external devices that
shall cover the entire foot and ankle. contact breached or compromised surfaces for limited expo-
6.4.2 Separate protective clothing items are also permitted sures when passing the appropriate evaluations in accordance
in the form of footwear covers that shall provide protection of with ANSI/AAMI/ISO 10993.
the wearer’s footwear and that extend at least above the
7.4 Sterility Assurance Level:
wearer’s ankle.
7.4.1 If sterilization of the protective clothing item is
6.5 Protective clothing items shall be permitted to include specified as part of the pre-use or use procedures, the clothing
–6
integrated hoods to protect portions of the wearer’s head, neck, item shall achieve a sterility assurance level of at least 10 for
and face in conjunction with eye and face protection devices the selected sterilization process.
and appropriate respirators.
NOTE 8—Appropriate sterilization processes include those specified in
6.5.1 Protective clothing items shall also be permitted to be
ISO 11134 for moist heat, ISO 11135 for EtO, and ISO 11137 for gamma.
a separate hood with a clear visor to protect the wearer’s head,
ISO 13683 is a permitted alternative also for moist heat sterilization.
neck, and face in conjunction with appropriate respirators.
6.5.2 Where protective clothing items incorporate hoods,
8. Documentation Requirements
the hood shall cover at least the back and sides of the head and
8.1 If the manufacturer elects to provide physical property
neck.
information with its products, test and report the physical
6.6 The manufacturer shall specify all portions of the body properties of the protective clothing materials and seams as
covered by the protective clothing item that is provided with
specified in Table 3.
chemotherapy or hazardous drug barrier protection. Any por-
8.2 If the protective clothing materials are to be represented
tion of the protective clothing item that can potentially come
as breathable, then material breathability is permitted to be
into contact with liquid chemotherapy or other liquid hazard-
tested using either the evaporative resistance or water vapor
ous drugs shall include barrier material.
transmission rate as specified in Table 3.
7. Performance Requirements
9. Sampling
7.1 Permeation Resistance:
9.1 Select representative specimens of barrier materials and
7.1.1 To be labeled as meeting this standard for broad
seams from the protective clothing item for testing.
chemotherapy drug protection, each barrier material specimen
9.1.1 If the protective clothing includes more than one
and each seam specimen tested shall be tested against each of
barrier material, then separately test each unique barrier
the seven Table 1 drugs and exhibit a breakthrough detection
material.
time of 30 min or more for each chemotherapy drug.
9.1.2 Iftheprotectiveclothingitemusesmorethanonetype
7.1.2 To be labeled as meeting this standard for selective
of seam construction, then separately test each different type of
chemotherapy drug protection, each barrier material specimen
clothing barrier material seam.
and each seam specimen tested shall exhibit a breakthrough
NOTE 9—Seam construction in a protective clothing item can vary
detection time of 30 min or more for at least five of the
based on the stitch type and number of stitches per inch (for sewn seams)
chemotherapy drugs specified in Table 1.
and by the seam type (configuration) and technique by which seams may
NOTE 6—A set of specimens, in permeation testing, is the full number be sealed (for example, ultrasonic, RF, and taping). For the purpose of this
specification, barrier materials do not include knit cuffs if used in the
of test replicates separately for material and seam. For interpreting the
above requirement, the lowest breakthrough detection time in each set construction of the clothing item or the seam by which the knit cuff is
attached to the clothing item sleeve.
must be 30 min or greater. For example, if a protective clothing item has
onetypeofmaterialthathasmeasuredbreakthroughdetectiontimesof45,
9.1.3 If the seam specimens include at least 10 mm of
30, and 30 min, and a single seam type that yields breakthrough detection
barrier material unaffected by the seam on either side of the
times of 45, 60, and 60 min, the lowest breakthrough detection time for
seam as the exposed area in the permeation test cell, then
both sets of permeation resistance data is 30 min.
testing of the barrier material alone is not required.
7.1.3 When specific permeation data is provided by the
manufacturer for other liquid chemotherapy and hazardous 9.2 Where specified by the purchaser or organization re-
drugs, the breakthrough detection time reported for each viewing the product, test multiple lots of protective clothing
additional drug shall be the lowest result obtained on each items to demonstrate consistent performance for the respective
barrier material and seam. protective clothing product.
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A
TABLE 3 Physical Property Documentation Requirements (Documentation Only)
Performance Property Test Method Subsection Reported Data
B C
Tensile strength ASTM D5034 11.5 Average tensile strength for each material direction
B C
Tear resistance ASTM D5587 11.6 Average tearing force for each material direction
Burst strength ASTM D3786/D3786M (woven); 11.7 Average burst strength
ASTM D3787 (nonwoven or knit)
Seam strength ASTM D751 (stretch woven or knit) or ASTM 11.8 Average seam strength for each seam type used in the
D1683/D1683M (woven or nonwoven) protective clothing item
D
Evaporative resistance or ASTM F1868, Part B 11.9 Average evaporative resistance for all material layers
used in the construction of the protective clothing
D
Water vapor transmission rate ASTM D6701, ASTM E96/E96M, or WSP 70.4 11.10 Average water vapor transmission rate for all material
(nonwoven and plastic barrier materials) layers used in construction of the protective clothing
A
Appendix X1 provides a description of each method, its intended application, and limitations.
B
Measurement of tensile and tear strength properties may not be indicative of snag or puncture resistance. There are no generally accepted test methods for snag or
puncture resistance available at this time.
C
This standard follows industry practice for reporting strength properties in both material directions (warp and fill, machine and cross-machine, or wales and course as
specified by the manufacturer) to provide the end user with a comparison of material performance because a material may have different strengths associated with each
direction of its manufacture.
D
This standard permits reporting either evaporative resistance or water vapor transmission rate if the user of this standard elects to report the protective clothing material
as breathable. Appendix X1 provides a comparison of the two methods with their respective procedures, application, and limitations. Garment comfort is a function of
several factors, including but not limited to, fabric “breathability,” garment design, weight, fabric stiffness, the degree of garment fit on the individual wearer, and other
possible individual wearer preferences (for example, noise, odor). Due to the complexity of these factors, the best assessment of overall protective clothing comfort can
be made through actual wear testing. Measuring the breathability of the fabrics used to construct protective clothing is one method of predicting thermal comfort. Those
protective clothing items that are designed and constructed of materials which more freely allow evaporation of perspiration and body heat transfer provide better thermal
comfort. When protective clothing is constructed or reinforced with different materials in different areas of the garment, then testing the breathability of all the materials
is important to help gain an understanding of the impact of overall garment design on thermal comfort. Comparisons of breathability between different protective clothing
materials should only be made using the same test method. Also included in Appendix X1 are other potential factors that can affect comfort.
NOTE 10—While this specification can be used to make claims of
the drug to which a worker might be exposed during handling
performance against liquid chemotherapy and other liquid hazardous
asreferencedinthemostrecenteditionofthePhysicians’Desk
drugs, it is not a quality control standard. Examples of acceptable
Reference, or the package insert of the test drug. Document the
sampling plans for the other physical properties are found in references
concentration and preparation procedures for each chemo-
such as ANSI/ASQ Z1.4 and Z1.9, ISO 2859-1, and ISO 3951.
therapy and hazardous drug that is tested.
10. Conditioning
11.1.2 Conductpermeationtestingat27 63 °C[81 65 °F]
and record the actual test temperature.
10.1 Ambient Conditioning—Condition all specimens at a
11.1.3 Choose a collection medium appropriate for the
temperature of 27 6 3 °C [81 6 5 °F] and relative humidity of
specific drug being tested which does not influence the
65 6 10 % for at least 24 h according to Practice D1776/
permeation of the drug through the protective clothing material
D1776M, unless otherwise specified by the selected test
or seam. Ensure that the collection medium is continuously
method.
mixed.
10.2 Sterilization—If specified by the manufacturer for use
NOTE 11—If other than distilled water is used, an assessment is needed
of the protective clothing, sterilize specimens from protective
to determine that the collection medium does not influence the permeation
clothing items using the manufacturer’s recommended steril-
behavior of the drug through the respective protective clothing material or
ization process and specific sterilization cycle parameters (for
seam.
example, time, temperature, sterilant concentration, humidity,
11.1.4 Selectandapplyadetectionmethodthatiscapableof
etc.) prior to ambient conditioning of specimens prior to
analyzing the concentration of the drug to achieve a minimum
testing.
detectable permeation rate of 0.01 µg⁄cm min.
11. Test Methods NOTE 12—The selected minimum detectable permeation rate is one
order of magnitude below the permeation rate that is used to establish the
11.1 Permeation Resistance—Use Test Method F739 with
standardized breakthrough time and is specified in Test Method F739.
the conditions and procedures stated hereafter to measure the
NOTE 13—If available, it is recommended to use the drug manufactur-
permeationresistanceofeachtypeofbarriermaterialandseam er’s specified detection method for analysis of the drug concentration in
the collection medium.
against all seven chemotherapy drugs listed in Table 1 and any
other liquid chemotherapy or liquid hazardous drugs, such as 11.1.5 Configure the permeation test cell in a closed-loop
those listed in Table 2, depending on the type of product configuration.
labeling claims to be made. 11.1.6 Measure the concentration of the drug in the collec-
11.1.1 For each chemotherapy or hazardous drug to be tion medium at the start time, and at 30, 60, 120, and 240 min
tested, prepare the chemotherapy or hazardous drug using the after the start time.
manufacturer’s or clinician’s recommended solvent, co- 11.1.7 Terminatethetestafter4 hunlessalongertestperiod
solvent, and other additives and at the highest concentration of is specified.
F3267−22
NOTE14—TestMethodF739specifiestriplicatetesting.If,forexample,
11.3 Biocompatibility—Where required for protective cloth-
theprotectiveclothingincludesonetypeofmaterialandonetypeofseam,
ingintendedforuseasamedicaldevice,assessthecytotoxicity
atotalofsixspecimenswillcomposethesetofspecimenstestedwitheach
of all materials used in the construction of the clothing in
drug. If the clothing includes one type of material and two types of seams,
accordance with ISO/ANSI/AAMI 10993-5, sensitization in
a total of nine specimens will compose the set of specimens tested with
accordance with ISO/ANSI/AAMI 10993-10, and irritation in
each drug.
accordance with ISO/ANSI/AAMI 10993-23.
11.1.8 Test Results—From the concentrations measured in
11.3.1 All clothing materials shall include materials in each
11.1.6, measure the standardized breakthrough time and calcu-
color, as well as other different materials and components such
late the cumulative mass permeated at each sampling point.
as thread and elastic, seam binding, or knit cuffs, if used in the
11.1.8.1 Determine when breakthrough has occurred when
clothing’s construction.
the quantitative analysis detects permeation at a rate of
11.3.2 Samples for testing shall include individual materials
0.1 µg⁄cm min. Report the breakthrough detection time at the
and components or portions of the clothing that contain
ending time of the preceding sampling period where the
representative samples of all material and components.
permeation rate is below 0.1 µg⁄cm min.
Alternatively,asuitableextractiontechniquecanbeappliedfor
NOTE 15—As an example, if in the testing of the drug for permeation
representing the entire clothing item’s construction.
through a specific protective clothing material, the permeation rate is
2 11.4 Sterility Assurance—If sterilization of the protective
found to exceed 0.1 µg⁄cm min in the interval from 30 to 60 min where
clothing item is specified as part of the pre-use or use
the permeation rate is found to be below 0.1 µg⁄cm min during the
preceding 0 to 30 min sampling interval, then the breakthrough detection
procedures, assess the sterility assurance level for the entire
time is reported as 30 min.
protective clothing item using either ISO 11134 or ISO 13683
for moist heat sterilization, ISO 11135 for ethylene oxide
11.1.8.2 If the permeation rate is measured to be above
sterilization, or ISO 11137 for gamma radiation sterilization.
0.1 µg⁄cm min in the first sampling interval (0 to 30 min), then
Report the sterilization level achieved along with the specific
report the breakthrough detection time as <30 min.
sterilization procedures that were used for accomplishing the
11.1.8.3 If the permeation rate is measured to be below
sterilization.
0.1 µg⁄cm min for each interval through the end of 4 h test
period, then the report the breakthrough detection time as
11.5 Tensile Strength—Measure the tensile strength of each
>240 min.
material, except for fastening elements (for example, hook-
11.1.8.4 For reporting breakthrough detection time for each
and-loop closure tape, snaps, belts, ties, and cuffs), used in the
drug, use the lowest value of all the specimens in the set.
construction of the protective clothing item as specified in Test
11.1.8.5 Report the breakthrough detection time for the five
MethodD5034,followingtheconditioningspecifiedinSection
chemotherapydrugs(selectiveprotection)orallsevenrequired 10. Report the average tensile strength for each material
chemotherapy drugs (broad protection) from Table 1 and any
direction.
other drugs tested as <30 min, 30 min, 60 min, 120 min,
11.6 Tear Resistance—Measure the tear resistance of each
180 min, or >240 min.
material, except for fastening elements (for example, hook-
11.1.8.6 To meet the requirements of either broad or selec-
and-loop closure tape, snaps, belts, ties, and cuffs), used in the
tive protection, all specimens for all sets for all drugs, either
construction of the protective clothing item as specified in Test
seven or five respectively, must have breakthrough detection
Method D5587 (woven) using Option 1 to calculate the tearing
times ≥30 min.
force, following the conditioning specified in Section 10.
11.1.9 Calculate the cumulative permeation mass/area that
Report the average tear resistance for each material direction.
has occurred for 30 min, 60 min, and 240 min in µg/cm for
11.7 Burst Strength—Measure the burst strength of each
each replicate tested specimen and report the highest cumula-
material, except for fastening elements (for example, hook-
tive permeation mass/area for all replicates for a specific set of
and-loop closure tape, snaps, belts, ties, and cuffs), used in the
specimens for each chemotherapy or hazardous drug.
construction of the protective clothing item as specified in Test
NOTE 16—Instructions for calculating cumulative permeation masses
Method D3786/D3786M for woven materials or Test Method
are provided in Test Method F739.
D3787 for knit/nonwoven materials, following the condition-
ing specified in Section 10. Report the average burst strength.
11.1.10 If retesting i
...