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

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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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Publication Date
30-Nov-2022
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ASTM F3267-22 - Standard Specification for Protective Clothing for Use Against Liquid Chemotherapy and Other Liquid Hazardous Drugs
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation:F3267 −22
Standard Specification for
Protective Clothing for Use Against Liquid Chemotherapy
1
and Other Liquid Hazardous Drugs
This standard is issued under the fixed designation F3267; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.1.6 This specification also requires products intended to
be used as medical devices such as surgical gowns and
1.1 This specification establishes design, performance,
isolation gowns to meet the respective requirements of AAMI
documentation, and labeling requirements and provides test
PB70, Specification F2407/F2407M, and Specification F3352/
methods for protective clothing used in preventing exposure to
F3352M, as applicable.
liquid chemotherapy and other liquid hazardous drugs.
1.1.1 The principal requirement of this specification is
1.2 This specification does not address all conditions of
permeation resistance testing of the protective clothing barrier
exposure for individuals who wear protective clothing in the
material and seams to a specified battery of seven chemo-
manufacture, transport, compounding, preparation, and admin-
therapy drugs. Two levels of protective clothing barrier mate-
istration of liquid chemotherapy and other hazardous drugs in
rial and seam performance are established for complying with
additiontopatientcareactivitiesandspillswherecontaminated
Part A labeling requirements specific to these seven liquid
items with these drugs are encountered.
chemotherapy drugs.
1.3 This specification does not address chemotherapy drugs
1.1.1.1 Broad chemotherapy drug protection is based on the
or hazardous drugs that may be encountered in the form of a
protective clothing barrier material and seams demonstrating
vapor or aerosol and does not provide any criteria for respira-
breakthrough detection times of 30 min or more for the seven
tory protection.
specified chemotherapy drugs.
1.1.1.2 Selective chemotherapy drug protection is based on
1.4 This specification does not address the selection, use, or
the protective clothing barrier material and seams demonstrat-
care of protective clothing used for protection against liquid
ing breakthrough detection times of 30 min or more for at least
chemotherapy or other liquid hazardous drugs. While this
five of the seven specified chemotherapy drugs.
specification does not specifically determine which barrier
1.1.2 It is also possible to report permeation resistance test
material to select, the results of the tests described in this
results for additional liquid chemotherapy and other liquid
specification are useful for selecting barrier materials by
hazardous drugs of interest as determined by the manufacturer
comparing the test results among different materials under
orenduserorganizationusingthesamebreakthroughdetection
consideration. See USP 800, Hazardous Drugs—Handling In
criteria for individual drugs for complying with the Part B
Healthcare Settings, for specific guidelines on the selection,
labeling requirements.
use,andcareofpersonalprotectiveequipmentforprotectionof
1.1.3 Protective clothing meeting this specification is also
healthcare workers against chemotherapy or other hazardous
required to meet minimum flammability requirements, and if
drugs.
used as a medical device, biocompatibility (if used for
1.5 This specification is intended to provide the basis for
breached skin contact), and demonstrate sterility assurance, if
manufacturers or suppliers to make specific claims that protec-
sterilized prior to use.
tive clothing products provide protection against liquid che-
1.1.4 Physical properties that indicate the strength,
motherapy and other liquid hazardous drugs.
durability, and breathability of the protective clothing are
optionally reported.
1.6 The values stated in SI units or in other units shall be
1.1.5 Additional requirements are established for the label
regarded separately as standard. The values stated in each
and user information to be provided for protective clothing
system must be used independently of the other, without
meeting this specification.
combining values in any way.
1.7 This standard does not purport to address all of the
1
This specification is under the jurisdiction of ASTM Committee F23 on
safety concerns, if any, associated with its use. It is the
Personal Protective Clothing and Equipment and is the direct responsibility of
responsibility of the user of this standard to establish appro-
Subcommittee F23.30 on Chemicals
...

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