ASTM F2407-06
(Specification)Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
ABSTRACT
This specification establishes the requirements for the performance, documentation, and labeling of surgical gowns used in the healthcare facilities. It does not however cover all the requirements that a healthcare facility deems necessary to select a product, nor does it address criteria for evaluating experimental products. Barrier testing shall be conducted to determine the impact penetration, hydrostatic resistance, and viral penetration resistance performance of the critical zone(s) of the surgical gown. The physical properties of the critical zone(s) of the surgical gown shall also be tested and shall conform to the following requirements: tensile strength, tear resistance, seam strength, lint generation, evaporative resistance, and water vapor transmission rate. General safety requirements shall be set based on biocompatibility, sterility assurance, flame spread, and natural rubber latex specifications.
SCOPE
1.1 This specification establishes requirements for the performance, documentation, and labeling of surgical gowns used in the healthcare facilities. Four levels of barrier properties for surgical gowns are specified in AAMI PB70:2003 and are included in this specification for reference purposes.Note 1
Some properties require minimum performance and others are for documentation only.Note 2
AAMI PB70:2003 evaluates the barrier properties of surgical gown fabrics using water only in Levels 1, 2, and 3. Since surgical gowns are exposed to blood and other fluids with different surface tensions, the performance of additional testing to identify the barrier levels to simulated biological fluids is required for a Level 4 gown.
1.2 This specification does not cover all the requirements that a healthcare facility deems necessary to select a product, nor does it address criteria for evaluating experimental products.
1.3 This specification is not intended to serve as a detailed manufacturing or purchase specification, but can be referenced in purchase specifications as the basis for selecting test requirements.
1.4 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.
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 and health practices and determine the applicability of regulatory limitations prior to use.
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Designation:F2407 −06
StandardSpecification for
Surgical Gowns Intended for Use in Healthcare Facilities
This standard is issued under the fixed designation F2407; 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
Healthcare protective clothing, including surgical gowns, is worn by healthcare workers to protect
both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and other
contaminants from one person to another.
Healthcare workers can be exposed to biological fluids capable of transmitting disease. These
diseases, which may be caused by a variety of microorganisms, can pose significant risks to life and
health. This is especially true of blood-borne pathogens, such as Hepatitis [Hepatitis B Virus (HBV)
andHepatitisCVirus(HCV)],andHumanImmunodeficiencyVirus(HIV).Sinceengineeringcontrols
cannot eliminate all possible exposures, attention is placed on reducing the potential of direct skin
contact with microorganisms, body fluids, and other potentially infectious materials through the use
of protective apparel.
Thisspecificationaddressestheperformanceofsurgicalgownsdesignedtopreservethesterilefield
and/or protect against exposure of healthcare workers to blood, body fluids, and other potentially
infectious materials during surgery and other healthcare procedures.
This specification establishes uniform testing and reporting requirements for surgical gown
manufacturers in order to provide information to end-users that can be used in making informed
decisions in the selection and purchase of surgical gowns according to the anticipated exposures.This
information is also useful for helping end users comply with the Occupational Safety and Health
Administration’s Blood-borne Pathogen Standard (29 CFR 1910.1030).
1. Scope 1.3 This specification is not intended to serve as a detailed
manufacturing or purchase specification, but can be referenced
1.1 This specification establishes requirements for the
in purchase specifications as the basis for selecting test
performance, documentation, and labeling of surgical gowns
requirements.
used in the healthcare facilities. Four levels of barrier proper-
ties for surgical gowns are specified in AAMI PB70:2003 and 1.4 The values stated in SI units or in other units shall be
are included in this specification for reference purposes. regarded separately as standard. The values stated in each
system must be used independently of the other, without
NOTE1—Somepropertiesrequireminimumperformanceandothersare
combining values in any way.
for documentation only.
NOTE 2—AAMI PB70:2003 evaluates the barrier properties of surgical
1.5 This standard does not purport to address all of the
gown fabrics using water only in Levels 1, 2, and 3. Since surgical gowns
safety concerns, if any, associated with its use. It is the
are exposed to blood and other fluids with different surface tensions, the
responsibility of the user of this standard to establish appro-
performanceofadditionaltestingtoidentifythebarrierlevelstosimulated
priate safety and health practices and determine the applica-
biological fluids is required for a Level 4 gown.
bility of regulatory limitations prior to use.
1.2 This specification does not cover all the requirements
that a healthcare facility deems necessary to select a product,
2. Referenced Documents
nor does it address criteria for evaluating experimental prod-
2.1 ASTM Standards:
ucts.
D751 Test Methods for Coated Fabrics
This specification is under the jurisdiction of ASTM Committee F23 on
Personal Protective Clothing and Equipment and is the direct responsibility of For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Subcommittee F23.40 on Biological. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved May 1, 2006. Published June 2006. DOI: 10.1520/ Standards volume information, refer to the standard’s Document Summary page on
F2407-06. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2407−06
D1683 Test Method for Failure in Sewn Seams of Woven ISO 11137 Sterilization of healthcare products—
Apparel Fabrics Requirements for validation and routine control—
D1776 Practice for Conditioning and Testing Textiles Radiation sterilization
D5034 TestMethodforBreakingStrengthandElongationof ISO 13683 Sterilization of healthcare products—
Textile Fabrics (Grab Test) Requirements for validation and routine control of moist
D5587 Test Method for Tearing Strength of Fabrics by heat sterilization in healthcare facilities
Trapezoid Procedure
2.6 Federal Standards:
D5733 Test Method for Tearing Strength of Nonwoven 16 CFR 1610 Standard for the Flammability of Clothing
Fabrics by the Trapezoid Procedure (Withdrawn 2008)
Textiles, Federal Register, Vol. 40, No. 59891, Dec. 30,
D6701 Test Method for Determining Water Vapor Transmis- 1975
sionRatesThroughNonwovenandPlasticBarriers(With-
21 CFR Parts 801.437 and 878.4040 Surgical Apparel,
drawn 2008) Federal Register, Vol. 63, No. 318, Nov. 12, 1998, pp.
F1494 Terminology Relating to Protective Clothing
63247.
F1671 Test Method for Resistance of Materials Used in 29 CFR Part 1910.1030 Occupational Exposure to Blood-
Protective Clothing to Penetration by Blood-Borne Patho-
borne Pathogens: Final Rule, Federal Register, Vol. 66,
gens Using Phi-X174 Bacteriophage Penetration as a Test
No. 12 / Thursday, January 18, 2001.
System
3. Terminology
F1868 Test Method for Thermal and Evaporative Resistance
of Clothing Materials Using a Sweating Hot Plate
3.1 Definitions:
2.2 AAMI Documents:
3.1.1 bloodborne pathogen, n—an infectious bacterium or
AAMI PB70:2003 Liquid barrier performance and classifi-
virus, or other disease-inducing microbe carried in blood or
cation of protective apparel and drapes intended for use in
other potentially infectious body fluids.
healthcare facilities
3.1.1.1 Discussion—For the purpose of this test method, the
AAMI ST65:2000 Processing of multiple-use surgical tex-
primary blood-borne pathogens include Hepatitis B Virus
tiles for use in health care facilities
(HBV), Hepatitis C Virus (HCV), and Human Immunodefi-
AAMI TIR11:1994 Selection of Surgical Gowns and Drapes
ciency Virus (HIV). Other microorganisms must be considered
in Healthcare Facilities
on a case-by-case basis.
AAMI/ANSI BE78:2002 Biological Evaluation of Medical
3.1.2 body fluid, n—any liquid produced, secreted, or ex-
Devices, Part 10: Test for Irritation and Sensitization
creted by the human body.
2.3 AATCC Standards:
3.1.2.1 Discussion—In this specification, body fluids in-
AATCC 42 Water Penetration Resistance: Impact Penetra-
clude liquids potentially infected with blood-borne pathogens,
tion Test
including, but not limited to, blood, semen, vaginal secretions,
AATCC 127 Water Resistance: Hydrostatic Pressure Test
cerebrospinal fluid, synovial fluid and peritoneal fluid, amni-
2.4 ANSI/ASQC Standard:
otic fluid, saliva in dental procedures, and any body fluid that
ANSI/ASQC Z1.4 Sampling Procedures and Tables for In-
is visibly contaminated with blood, and all body fluids in
spection by Attributes
situations where it is difficult or impossible to differentiate
2.5 ISO Standards:
between body fluids (see 29 CFR Part 1910.1030).
ISO 2859-1 Sampling plans for inspection by attributes
3.1.3 critical zone(s), n—area of a gown where direct
ISO 3951 Sampling procedures and charts for inspection by
contactwithblood,bodyfluids,andotherpotentiallyinfectious
variables for percent non-conforming
materials is most likely to occur.
ISO 9073 Part 10 Textiles—Test methods for nonwovens—
3.1.3.1 Discussion—Annex B of AAMI PB70:2003 pro-
Part 10: Lint and other particles generation in the dry state
vides examples of barrier classification for surgical gowns
ISO 10993-10 Biological evaluation of medical devices—
based on the critical zone(s). The critical zone can encompass
Part 10: Tests for irritation and delayed-type hypersensi-
multiple parts of the garment.
tivity
3.1.4 critical zone component, n—any element, constituent,
ISO 11134 Sterilization of healthcare products—
or item incorporated into the critical zone, including the
Requirements for validation and routine control—
materials, seams and attachments.
Industrial moist heat sterilization
3.1.4.1 Discussion—Seams at the boundary between the
ISO 11135 Medical devices—Validation and routine control
critical and non-critical zones are not considered parts of the
of ethylene oxide sterilization
critical zone(s).
3.1.5 flammability, n—those characteristics of a material
The last approved version of this historical standard is referenced on
that pertain to its ignition and support of combustion.
www.astm.org.
Available from the Association for the Advancement of Medical
3.1.6 healthcare protective clothing, n—protective clothing
Instrumentation, 110 North Glebe Road, Suite 220, Arlington, VA 22201.
used in a healthcare setting.
Available from American Association of Textile Chemists and Colorists
(AATCC), One Davis Dr., P.O. Box 12215, Research Triangle Park, NC 27709-
2215.
6 7
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St., AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
4th Floor, New York, NY 10036. 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401.
F2407−06
3.1.7 multiple-use, adj—refers to an item of protective shields, surgical caps or hoods, surgical masks, or respirators;
clothing that is intended to be used several times with protective clothing for the feet, such as operating room shoes,
appropriate care of the protective clothing item between use. shoe covers, or surgical boots; or other types of protective
3.1.7.1 Discussion—In this specification, multiple-use pro- clothing and equipment worn by health care providers.
tective clothing is subject to cleaning (laundering) and steril-
4.3 Surgical gowns are either multiple-use or single-use
ization between each use.
products as designated by the manufacturer. This specification
3.1.8 other potentially infectious materials, n—any
is intended to provide the basis for manufacturer claims for
materials, other than blood or body fluids, containing blood-
surgical gown performance and efficacy. For multiple-use
borne pathogens or materials that have been linked with the
gowns,thisspecificationtakesintoaccounttheanticipatedcare
potential transmission of infectious disease.
and maintenance of these products, by examining test require-
ments for surgical gown materials both before and after the
3.1.9 protective clothing, n—an item of clothing that is
maximum expected number of cycles for laundering and
specifically designed and constructed for the intended purpose
sterilization.
of isolating all or part of the body from a potential hazard; or
isolating the external environment from contamination by the
4.4 Additional information on the processing of multiple-
wearer of the clothing.
use surgical gowns is provided in AAMI ST65:2000.
3.1.9.1 Discussion—Examples of protective clothing in-
4.5 While surgical gowns are classified for barrier perfor-
clude surgical gowns, isolation gowns, decontamination
mance as specified in AAMI PB70:2003, this specification
garments, aprons, sleeve protectors, and certain types of
establishes certain other physical performance and documen-
laboratory coats. The primary purpose of the protective cloth-
tation requirements for surgical gowns and their materials.
ing is to act as a barrier between the wearer and a hazard.
Design requirements and recommendations are also provided
However, the product may also offer protection as a barrier,
for surgical gowns.
whichpreventsthebodyfrombeingasourceofcontamination.
4.6 Additionalinformationforthetesting,selection,anduse
3.1.10 single use, adj—refers to an item of protective
of surgical gowns is provided in AAMI TIR11:1994.
clothing that is intended to be used once and then disposed.
3.1.10.1 Discussion—In this specification, single use pro- NOTE 3—Information on barrier classes inAAMI TIR11:1994 does not
currently match the levels established in AAMI PB70:2003. However,
tective clothing is subject to sterilization prior to use per the
AAMI TIR11:1994 provides other useful information that is intended to
manufacturer’s instructions.
aid in the selection and use of surgical gowns.
3.1.11 surgical gown, n—protectiveclothingthatisintended
5. Design Requirements
to be worn by operating room personnel during surgical
procedures to protect both the surgical patient and the operat-
5.1 Surgical gowns shall be designed to comply with the
ing room personnel from the transfer of microorganisms, body
barrier performance requirements of AAMI PB70:2003.
fluids, and particulate matter.
5.2 Surgical gowns which are intended for reuse shall have
3.1.11.1 Discussion—This definition is consistent with the
affixed or attached a means for marking or recording the
definition provided by the U.S. Food and DrugAdministration
number of laundering and sterilization cycles to which the
(21 CFR 878.4040) except that the word “device” is used
specific item has been subjected.
instead of protective clothing.
5.3 The sizes of the critical zone(s) of a surgical gown shall
3.2 For definitions of other protective clothing-related terms
be defined by anatomical reference in accordance with
used in this test method refer to Terminology F1494.
AAMI PB70:2003.
4. Significance and Use
6. General Safety and Performance Requirements
4.1 This specification provides requirements for surgical
6.1 Biocompatibility
gowns used for protection of healthcare workers where the
6.1.1 Materials used in the construction of surgical gowns
potential for exposure to blood, body fluids, and other poten-
shall be classified as external devices that contact breached or
tially infectious materials exists. The specification requires
compromised surfaces for limited exposures and shall pass the
barrier testing based on the system of classifying gowns
appropriate evaluations in accordance with AAMI/
established in AAMI PB70:2003 and sets general safety re-
ANSI BE78:2002.Alternatively, ISO 10993-10 is permitted to
quirements for surgical gowns based on biocompatibility,
be used.
sterility assurance, and flame spread. Documentation and
reportingrequirementsaresetforimportantphysicalproperties 6.2 Sterility assurance level
including tensile strength, tear resistance, seam strength, lint- 6.2.1 The selec
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