ASTM F2407-06(2013)e1

Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities

SIGNIFICANCE AND USE
4.1 This specification provides 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 AAMI PB70 and sets general safety requirements for surgical gowns based on biocompatibility, sterility assurance, and flame spread. Documentation and reporting requirements are set for important physical properties including tensile strength, tear resistance, seam strength, linting resistance, evaporative resistance testing, and water vapor transmission rate.  
4.2 This specification does not address protective clothing used for non-surgical applications, such as isolation gowns or decontamination gowns; protective clothing for the hands, such as surgical gloves, patient examination gloves, or other medical gloves; protective clothing for the head, such as goggles or face shields, surgical caps or hoods, surgical masks, or respirators; protective clothing for the feet, such as operating room shoes, shoe covers, or surgical boots; or other types of protective clothing and equipment worn by health care providers.  
4.3 Surgical gowns are either multiple-use or single-use products as designated by the manufacturer. This specification is intended to provide the basis for manufacturer claims for surgical gown performance and efficacy. For multiple-use gowns, this specification takes into account the anticipated care and maintenance of these products, by examining test requirements for surgical gown materials both before and after the maximum expected number of cycles for laundering and sterilization.  
4.4 Additional information on the processing of multiple-use surgical gowns is provided in AAMI ST65.  
4.5 While surgical gowns are classified for barrier performance as specified in AAMI PB70, this specification establishes certain other physical performance an...
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 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 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.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 14-May-2013
• ICS: 11.140 - Hospital equipment
• ICS: 13.340.10 - Protective clothing
• Technical Committee: F23 - Personal Protective Clothing and Equipment
• Drafting Committee: F23.40 - Biological

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation:F2407 −06 (Reapproved 2013)
Standard Specification 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.
ε NOTE—Reapproved with the editorial removal of year dates from referenced documents in May 2013.
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).
performanceofadditionaltestingtoidentifythebarrierlevelstosimulated
1. Scope
biological fluids is required for a Level 4 gown.
1.1 This specification establishes requirements for the
1.2 This specification does not cover all the requirements
performance, documentation, and labeling of surgical gowns
that a healthcare facility deems necessary to select a product,
used in the healthcare facilities. Four levels of barrier proper-
nor does it address criteria for evaluating experimental prod-
ties for surgical gowns are specified in AAMI PB70 and are
ucts.
included in this specification for reference purposes.
1.3 This specification is not intended to serve as a detailed
NOTE1—Somepropertiesrequireminimumperformanceandothersare
for documentation only. manufacturing or purchase specification, but can be referenced
NOTE 2—AAMI PB70 evaluates the barrier properties of surgical gown
in purchase specifications as the basis for selecting test
fabrics using water only in Levels 1, 2, and 3. Since surgical gowns are
requirements.
exposed to blood and other fluids with different surface tensions, the
1.4 The values stated in SI units or in other units shall be
regarded separately as standard. The values stated in each
This specification is under the jurisdiction of ASTM Committee F23 on
system must be used independently of the other, without
Personal Protective Clothing and Equipment and is the direct responsibility of
Subcommittee F23.40 on Biological. combining values in any way.
Current edition approved May 15, 2013. Published June 2013. Originally
1.5 This standard does not purport to address all of the
approved in 2006. Last previous edition approved in 2006 as F2407 – 06. DOI:
10.1520/F2407-06R13E01. safety concerns, if any, associated with its use. It is the
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F2407−06 (2013)
responsibility of the user of this standard to establish appro- ISO 9073 Part 10 Textiles—Test methods for nonwovens—
priate safety and health practices and determine the applica- Part 10: Lint and other particles generation in the dry state
bility of regulatory limitations prior to use. ISO 10993-10 Biological evaluation of medical devices—
Part 10: Tests for irritation and delayed-type hypersensi-
2. Referenced Documents
tivity
2.1 ASTM Standards: ISO 11134 Sterilization of healthcare products—
Requirements for validation and routine control—
D751 Test Methods for Coated Fabrics
D1683 Test Method for Failure in Sewn Seams of Woven Industrial moist heat sterilization
ISO 11135 Medical devices—Validation and routine control
Apparel Fabrics
D1776 Practice for Conditioning and Testing Textiles of ethylene oxide sterilization
ISO 11137 Sterilization of healthcare products—
D5034 TestMethodforBreakingStrengthandElongationof
Textile Fabrics (Grab Test) Requirements for validation and routine control—
Radiation sterilization
D5587 Test Method for Tearing Strength of Fabrics by
Trapezoid Procedure ISO 13683 Sterilization of healthcare products—
D5733 Test Method for Tearing Strength of Nonwoven Requirements for validation and routine control of moist
heat sterilization in healthcare facilities
Fabrics by the Trapezoid Procedure (Withdrawn 2008)
D6701 Test Method for Determining Water Vapor Transmis-
2.6 Federal Standards:
sionRatesThroughNonwovenandPlasticBarriers(With-
16 CFR 1610 Standard for the Flammability of Clothing
drawn 2008)
Textiles, Federal Register, Vol. 40, No. 59891, Dec. 30,
F1494 Terminology Relating to Protective Clothing
F1671 Test Method for Resistance of Materials Used in
21 CFR Parts 801.437 and 878.4040 Surgical Apparel,
Protective Clothing to Penetration by Blood-Borne Patho-
Federal Register, Vol. 63, No. 318, Nov. 12, 1998, pp.
gens Using Phi-X174 Bacteriophage Penetration as a Test
63247.
System
29 CFR Part 1910.1030 Occupational Exposure to Blood-
F1868 Test Method for Thermal and Evaporative Resistance
borne Pathogens: Final Rule, Federal Register, Vol. 66,
of Clothing Materials Using a Sweating Hot Plate
No. 12 / Thursday, January 18, 2001.
2.2 AAMI Documents:
AAMI PB70 Liquid barrier performance and classification
3. Terminology
of protective apparel and drapes intended for use in
3.1 Definitions:
healthcare facilities
3.1.1 bloodborne pathogen, n—an infectious bacterium or
AAMI ST65 Processing of multiple-use surgical textiles for
virus, or other disease-inducing microbe carried in blood or
use in health care facilities
other potentially infectious body fluids.
AAMI TIR11 Selection of Surgical Gowns and Drapes in
3.1.1.1 Discussion—For the purpose of this test method, the
Healthcare Facilities
primary blood-borne pathogens include Hepatitis B Virus
AAMI/ANSI BE78 Biological Evaluation of Medical
(HBV), Hepatitis C Virus (HCV), and Human Immunodefi-
Devices, Part 10: Test for Irritation and Sensitization
ciency Virus (HIV). Other microorganisms must be considered
2.3 AATCC Standards:
on a case-by-case basis.
AATCC 42 Water Penetration Resistance: Impact Penetra-
3.1.2 body fluid, n—any liquid produced, secreted, or ex-
tion Test
creted by the human body.
AATCC 127 Water Resistance: Hydrostatic Pressure Test
3.1.2.1 Discussion—In this specification, body fluids in-
2.4 ANSI/ASQC Standard:
clude liquids potentially infected with blood-borne pathogens,
ANSI/ASQC Z1.4 Sampling Procedures and Tables for In-
including, but not limited to, blood, semen, vaginal secretions,
spection by Attributes
cerebrospinal fluid, synovial fluid and peritoneal fluid, amni-
2.5 ISO Standards:
otic fluid, saliva in dental procedures, and any body fluid that
ISO 2859-1 Sampling plans for inspection by attributes
is visibly contaminated with blood, and all body fluids in
ISO 3951 Sampling procedures and charts for inspection by
situations where it is difficult or impossible to differentiate
variables for percent non-conforming
between body fluids (see 29 CFR Part 1910.1030).
3.1.3 critical zone(s), n—area of a gown where direct
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contactwithblood,bodyfluids,andotherpotentiallyinfectious
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on materials is most likely to occur.
the ASTM website.
3.1.3.1 Discussion—Annex B of AAMI PB70 provides ex-
The last approved version of this historical standard is referenced on
amples of barrier classification for surgical gowns based on the
www.astm.org.
critical zone(s).The critical zone can encompass multiple parts
Available from the Association for the Advancement of Medical
Instrumentation, 110 North Glebe Road, Suite 220, Arlington, VA 22201.
of the garment.
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.
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F2407−06 (2013)
3.1.4 critical zone component, n—any element, constituent, ments for surgical gowns based on biocompatibility, sterility
or item incorporated into the critical zone, including the assurance, and flame spread. Documentation and reporting
materials, seams and attachments. requirements are set for important physical properties includ-
3.1.4.1 Discussion—Seams at the boundary between the ing tensile strength, tear resistance, seam strength, linting
critical and non-critical zones are not considered parts of the resistance, evaporative resistance testing, and water vapor
critical zone(s). transmission rate.
3.1.5 flammability, n—those characteristics of a material
4.2 This specification does not address protective clothing
that pertain to its ignition and support of combustion.
used for non-surgical applications, such as isolation gowns or
decontaminationgowns;protectiveclothingforthehands,such
3.1.6 healthcare protective clothing, n—protective clothing
assurgicalgloves,patientexaminationgloves,orothermedical
used in a healthcare setting.
gloves;protectiveclothingforthehead,suchasgogglesorface
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-
ization between each use. 4.3 Surgical gowns are either multiple-use or single-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-
3.1.9 protective clothing, n—an item of clothing that is
ments for surgical gown materials both before and after the
specifically designed and constructed for the intended purpose
maximum expected number of cycles for laundering and
of isolating all or part of the body from a potential hazard; or
sterilization.
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.
3.1.9.1 Discussion—Examples of protective clothing in-
clude surgical gowns, isolation gowns, decontamination
4.5 While surgical gowns are classified for barrier perfor-
garments, aprons, sleeve protectors, and certain types of
mance as specified in AAMI PB70, this specification estab-
laboratory coats. The primary purpose of the protective cloth-
lishes certain other physical performance and documentation
ing is to act as a barrier between the wearer and a hazard.
requirements for surgical gowns and their materials. Design
However, the product may also offer protection as a barrier,
requirements and recommendations are also provided for
whichpreventsthebodyfrombeingasourceofcontamination.
surgical gowns.
3.1.10 single use, adj—refers to an item of protective
4.6 Additionalinformationforthetesting,selection,anduse
clothing that is intended to be used once and then disposed.
of surgical gowns is provided in AAMI TIR11.
3.1.10.1 Discussion—In this specification, single use pro-
NOTE 3—Information on barrier classes in AAMI TIR11 does not
tective clothing is subject to sterilization prior to use per the
currently match the levels established in AAMI PB70. However,
manufacturer’s instructions.
AAMI TIR11 provides other useful information that is intended to aid in
3.1.11 surgical gown, n—protectiveclothingthatisintended the selection and use of surgical gowns.
to be worn by operating room personnel during surgical
procedures to protect both the surgical patient and the operat- 5. Design Requirements
ing room personnel from the transfer of microorganisms, body
5.1 Surgical gowns shall be designed to comply with the
fluids, and particulate matter.
barrier performance requirements of AAMI PB70.
3.1.11.1 Discussion—This definition is consistent with the
5.2 Surgical gowns which are intended for reuse shall have
definition provided by the U.S. Food and DrugAdministration
affixed or attached a means for marking or recording the
(21 CFR 878.4040) except that the word “device” is used
number of laundering and sterilization cycles to which the
instead of protective clothing.
specific item has been subjected.
3.2 For definitions of other protective clothing-related terms
5.3 The sizes of the critical zone(s) of a surgical gown shall
used in this test method refer to Terminology F1494.
be defined by anatomical reference in accordance with
AAMI PB70.
4. Significance and Use
4.1 This specification provides requirements for surgical
6. General Safety and Performance Requirements
gowns used for protection of healthcare workers where the
6.1 Biocompatibility
potential for exposure to blood, body fluids, and other pot
...