1、Designation: F2407 06 (Reapproved 2013)1Standard Specification forSurgical Gowns Intended for Use in Healthcare Facilities1This standard is issued under the fixed designation F2407; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, t
2、he year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1NOTEReapproved with the editorial removal of year dates from referenced documents in May 2013.INTRODUCTIONHealthcare p
3、rotective clothing, including surgical gowns, is worn by healthcare workers to protectboth the patient and the healthcare worker from the transfer of microorganisms, body fluids, and othercontaminants from one person to another.Healthcare workers can be exposed to biological fluids capable of transm
4、itting disease. Thesediseases, which may be caused by a variety of microorganisms, can pose significant risks to life andhealth. This is especially true of blood-borne pathogens, such as Hepatitis Hepatitis B Virus (HBV)and Hepatitis C Virus (HCV), and Human Immunodeficiency Virus (HIV). Since engin
5、eering controlscannot eliminate all possible exposures, attention is placed on reducing the potential of direct skincontact with microorganisms, body fluids, and other potentially infectious materials through the useof protective apparel.This specification addresses the performance of surgical gowns
6、 designed to preserve the sterile fieldand/or protect against exposure of healthcare workers to blood, body fluids, and other potentiallyinfectious materials during surgery and other healthcare procedures.This specification establishes uniform testing and reporting requirements for surgical gownmanu
7、facturers in order to provide information to end-users that can be used in making informeddecisions in the selection and purchase of surgical gowns according to the anticipated exposures. Thisinformation is also useful for helping end users comply with the Occupational Safety and HealthAdministratio
8、ns Blood-borne Pathogen Standard (29 CFR 1910.1030).1. Scope1.1 This specification establishes requirements for theperformance, documentation, and labeling of surgical gownsused in the healthcare facilities. Four levels of barrier proper-ties for surgical gowns are specified in AAMI PB70 and areincl
9、uded in this specification for reference purposes.NOTE 1Some properties require minimum performance and others arefor documentation only.NOTE 2AAMI PB70 evaluates the barrier properties of surgical gownfabrics using water only in Levels 1, 2, and 3. Since surgical gowns areexposed to blood and other
10、 fluids with different surface tensions, theperformance of additional testing to identify the barrier levels to simulatedbiological fluids is required for a Level 4 gown.1.2 This specification does not cover all the requirementsthat a healthcare facility deems necessary to select a product,nor does
11、it address criteria for evaluating experimental prod-ucts.1.3 This specification is not intended to serve as a detailedmanufacturing or purchase specification, but can be referencedin purchase specifications as the basis for selecting testrequirements.1.4 The values stated in SI units or in other un
12、its shall beregarded separately as standard. The values stated in eachsystem must be used independently of the other, withoutcombining values in any way.1.5 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is the1This specification is under the
13、 jurisdiction of ASTM Committee F23 onPersonal Protective Clothing and Equipment and is the direct responsibility ofSubcommittee F23.40 on Biological.Current edition approved May 15, 2013. Published June 2013. Originallyapproved in 2006. Last previous edition approved in 2006 as F2407 06. DOI:10.152
14、0/F2407-06R13E01.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1responsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use
15、.2. Referenced Documents2.1 ASTM Standards:2D751 Test Methods for Coated FabricsD1683 Test Method for Failure in Sewn Seams of WovenApparel FabricsD1776 Practice for Conditioning and Testing TextilesD5034 Test Method for Breaking Strength and Elongation ofTextile Fabrics (Grab Test)D5587 Test Method
16、 for Tearing Strength of Fabrics byTrapezoid ProcedureD5733 Test Method for Tearing Strength of NonwovenFabrics by the Trapezoid Procedure (Withdrawn 2008)3D6701 Test Method for Determining Water Vapor Transmis-sion Rates Through Nonwoven and Plastic Barriers (With-drawn 2008)3F1494 Terminology Rela
17、ting to Protective ClothingF1671 Test Method for Resistance of Materials Used inProtective Clothing to Penetration by Blood-Borne Patho-gens Using Phi-X174 Bacteriophage Penetration as a TestSystemF1868 Test Method for Thermal and Evaporative Resistanceof Clothing Materials Using a Sweating Hot Plat
18、e2.2 AAMI Documents:4AAMI PB70 Liquid barrier performance and classificationof protective apparel and drapes intended for use inhealthcare facilitiesAAMI ST65 Processing of multiple-use surgical textiles foruse in health care facilitiesAAMI TIR11 Selection of Surgical Gowns and Drapes inHealthcare F
19、acilitiesAAMI/ANSI BE78 Biological Evaluation of MedicalDevices, Part 10: Test for Irritation and Sensitization2.3 AATCC Standards:5AATCC 42 Water Penetration Resistance: Impact Penetra-tion TestAATCC 127 Water Resistance: Hydrostatic Pressure Test2.4 ANSI/ASQC Standard:6ANSI/ASQC Z1.4 Sampling Proc
20、edures and Tables for In-spection by Attributes2.5 ISO Standards:6ISO 2859-1 Sampling plans for inspection by attributesISO 3951 Sampling procedures and charts for inspection byvariables for percent non-conformingISO 9073 Part 10 TextilesTest methods for nonwovensPart 10: Lint and other particles ge
21、neration in the dry stateISO 10993-10 Biological evaluation of medical devicesPart 10: Tests for irritation and delayed-type hypersensi-tivityISO 11134 Sterilization of healthcare productsRequirements for validation and routine controlIndustrial moist heat sterilizationISO 11135 Medical devicesValid
22、ation and routine controlof ethylene oxide sterilizationISO 11137 Sterilization of healthcare productsRequirements for validation and routine controlRadiation sterilizationISO 13683 Sterilization of healthcare productsRequirements for validation and routine control of moistheat sterilization in heal
23、thcare facilities2.6 Federal Standards:716 CFR 1610 Standard for the Flammability of ClothingTextiles, Federal Register, Vol. 40, No. 59891, Dec. 30,197521 CFR Parts 801.437 and 878.4040 Surgical Apparel,Federal Register, Vol. 63, No. 318, Nov. 12, 1998, pp.63247.29 CFR Part 1910.1030 Occupational E
24、xposure to Blood-borne Pathogens: Final Rule, Federal Register, Vol. 66,No. 12 / Thursday, January 18, 2001.3. Terminology3.1 Definitions:3.1.1 bloodborne pathogen, nan infectious bacterium orvirus, or other disease-inducing microbe carried in blood orother potentially infectious body fluids.3.1.1.1
25、 DiscussionFor the purpose of this test method, theprimary blood-borne pathogens include Hepatitis B Virus(HBV), Hepatitis C Virus (HCV), and Human Immunodefi-ciency Virus (HIV). Other microorganisms must be consideredon a case-by-case basis.3.1.2 body fluid, nany liquid produced, secreted, or ex-cr
26、eted by the human body.3.1.2.1 DiscussionIn this specification, body fluids in-clude liquids potentially infected with blood-borne pathogens,including, but not limited to, blood, semen, vaginal secretions,cerebrospinal fluid, synovial fluid and peritoneal fluid, amni-otic fluid, saliva in dental pro
27、cedures, and any body fluid thatis visibly contaminated with blood, and all body fluids insituations where it is difficult or impossible to differentiatebetween body fluids (see 29 CFR Part 1910.1030).3.1.3 critical zone(s), narea of a gown where directcontact with blood, body fluids, and other pote
28、ntially infectiousmaterials is most likely to occur.3.1.3.1 DiscussionAnnex B of AAMI PB70 provides ex-amples of barrier classification for surgical gowns based on thecritical zone(s). The critical zone can encompass multiple partsof the garment.2For referenced ASTM standards, visit the ASTM website
29、, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.4Available from the Association
30、 for the Advancement of MedicalInstrumentation, 110 North Glebe Road, Suite 220, Arlington, VA 22201.5Available from American Association of Textile Chemists and Colorists(AATCC), One Davis Dr., P.O. Box 12215, Research Triangle Park, NC 27709-2215.6Available from American National Standards Institu
31、te (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.7Available from U.S. Government Printing Office Superintendent of Documents,732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401.F2407 06 (2013)123.1.4 critical zone component, nany element, constituent,or item incorporated into the cri
32、tical zone, including thematerials, seams and attachments.3.1.4.1 DiscussionSeams at the boundary between thecritical and non-critical zones are not considered parts of thecritical zone(s).3.1.5 flammability, nthose characteristics of a materialthat pertain to its ignition and support of combustion.
33、3.1.6 healthcare protective clothing, nprotective clothingused in a healthcare setting.3.1.7 multiple-use, adjrefers to an item of protectiveclothing that is intended to be used several times withappropriate care of the protective clothing item between use.3.1.7.1 DiscussionIn this specification, mu
34、ltiple-use pro-tective clothing is subject to cleaning (laundering) and steril-ization between each use.3.1.8 other potentially infectious materials, nanymaterials, other than blood or body fluids, containing blood-borne pathogens or materials that have been linked with thepotential transmission of
35、infectious disease.3.1.9 protective clothing, nan item of clothing that isspecifically designed and constructed for the intended purposeof isolating all or part of the body from a potential hazard; orisolating the external environment from contamination by thewearer of the clothing.3.1.9.1 Discussio
36、nExamples of protective clothing in-clude surgical gowns, isolation gowns, decontaminationgarments, aprons, sleeve protectors, and certain types oflaboratory coats. The primary purpose of the protective cloth-ing is to act as a barrier between the wearer and a hazard.However, the product may also of
37、fer protection as a barrier,which prevents the body from being a source of contamination.3.1.10 single use, adjrefers to an item of protectiveclothing that is intended to be used once and then disposed.3.1.10.1 DiscussionIn this specification, single use pro-tective clothing is subject to sterilizat
38、ion prior to use per themanufacturers instructions.3.1.11 surgical gown, nprotective clothing that is intendedto be worn by operating room personnel during surgicalprocedures to protect both the surgical patient and the operat-ing room personnel from the transfer of microorganisms, bodyfluids, and p
39、articulate matter.3.1.11.1 DiscussionThis definition is consistent with thedefinition provided by the U.S. Food and Drug Administration(21 CFR 878.4040) except that the word “device” is usedinstead of protective clothing.3.2 For definitions of other protective clothing-related termsused in this test
40、 method refer to Terminology F1494.4. Significance and Use4.1 This specification provides requirements for surgicalgowns used for protection of healthcare workers where thepotential for exposure to blood, body fluids, and other poten-tially infectious materials exists. The specification requiresbarr
41、ier testing based on the system of classifying gownsestablished in AAMI PB70 and sets general safety require-ments for surgical gowns based on biocompatibility, sterilityassurance, and flame spread. Documentation and reportingrequirements are set for important physical properties includ-ing tensile
42、strength, tear resistance, seam strength, lintingresistance, evaporative resistance testing, and water vaportransmission rate.4.2 This specification does not address protective clothingused for non-surgical applications, such as isolation gowns ordecontamination gowns; protective clothing for the ha
43、nds, suchas surgical gloves, patient examination gloves, or other medicalgloves; protective clothing for the head, such as goggles or faceshields, surgical caps or hoods, surgical masks, or respirators;protective clothing for the feet, such as operating room shoes,shoe covers, or surgical boots; or
44、other types of protectiveclothing and equipment worn by health care providers.4.3 Surgical gowns are either multiple-use or single-useproducts as designated by the manufacturer. This specificationis intended to provide the basis for manufacturer claims forsurgical gown performance and efficacy. For
45、multiple-usegowns, this specification takes into account the anticipated careand maintenance of these products, by examining test require-ments for surgical gown materials both before and after themaximum expected number of cycles for laundering andsterilization.4.4 Additional information on the pro
46、cessing of multiple-use surgical gowns is provided in AAMI ST65.4.5 While surgical gowns are classified for barrier perfor-mance as specified in AAMI PB70, this specification estab-lishes certain other physical performance and documentationrequirements for surgical gowns and their materials. Designr
47、equirements and recommendations are also provided forsurgical gowns.4.6 Additional information for the testing, selection, and useof surgical gowns is provided in AAMI TIR11.NOTE 3Information on barrier classes in AAMI TIR11 does notcurrently match the levels established in AAMI PB70. However,AAMI T
48、IR11 provides other useful information that is intended to aid inthe selection and use of surgical gowns.5. Design Requirements5.1 Surgical gowns shall be designed to comply with thebarrier performance requirements of AAMI PB70.5.2 Surgical gowns which are intended for reuse shall haveaffixed or att
49、ached a means for marking or recording thenumber of laundering and sterilization cycles to which thespecific item has been subjected.5.3 The sizes of the critical zone(s) of a surgical gown shallbe defined by anatomical reference in accordance withAAMI PB70.6. General Safety and Performance Requirements6.1 Biocompatibility6.1.1 Materials used in the construction of surgical gownsshall be classified as external devices that contact breached orcompromised surfaces for limited exposures and shall pass theF2407 06 (2013)13appropriate evaluations
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