ASTM F2407-2006 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities《康复设施中要求用外科医用工作服的标准规范》.pdf

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1、Designation: F 2407 06Standard Specification forSurgical Gowns Intended for Use in Healthcare Facilities1This standard is issued under the fixed designation F 2407; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last r

2、evision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.INTRODUCTIONHealthcare protective clothing, including surgical gowns, is worn by healthcare workers to protectboth the patient and the

3、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 transmitting disease. Thesediseases, which may be caused by a variety of microorganisms, can pose significant risks t

4、o 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 engineering controlscannot eliminate all possible exposures, attention is placed on reducing the potential of direct

5、 skincontact with microorganisms, body fluids, and other potentially infectious materials through the useof protective apparel.This specification addresses the performance of surgical gowns designed to preserve the sterile fieldand/or protect against exposure of healthcare workers to blood, body flu

6、ids, and other potentiallyinfectious materials during surgery and other healthcare procedures.This specification establishes uniform testing and reporting requirements for surgical gownmanufacturers in order to provide information to end-users that can be used in making informeddecisions in the sele

7、ction and purchase of surgical gowns according to the anticipated exposures. Thisinformation is also useful for helping end users comply with the Occupational Safety and HealthAdministrations Blood-borne Pathogen Standard (29 CFR 1910.1030).1. Scope1.1 This specification establishes requirements for

8、 the per-formance, documentation, and labeling of surgical gowns usedin the healthcare facilities. Four levels of barrier properties forsurgical gowns are specified in AAMI PB70:2003 and areincluded in this specification for reference purposes.NOTE 1Some properties require minimum performance and ot

9、hersare for documentation only.NOTE 2AAMI PB70:2003 evaluates the barrier properties of surgicalgown fabrics using water only in Levels 1, 2, and 3. Since surgical gownsare exposed to blood and other fluids with different surface tensions, theperformance of additional testing to identify the barrier

10、 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 it address criteria for evaluating experimental prod-ucts.1.3 This specification is not intended to s

11、erve 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 units shall beregarded separately as standard. The values stated in eachsystem must be used independent

12、ly 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 theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of

13、 regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D 751 Test Methods for Coated Fabrics1This specification is under the jurisdiction of ASTM Committee F23 onPersonal Protective Clothing and Equipment and is the direct responsibility ofSubcommittee F23.40 on Biological.C

14、urrent edition approved May 1, 2006. Published June 2006.2For referenced ASTM standards, visit the ASTM website, 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.1Cop

15、yright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.D 1683 Test Method for Failure in Sewn Seams of WovenApparel FabricsD 1776 Practice for Conditioning and Testing TextilesD 5034 Test Method for Breaking Strength and Elongationof Textile Fa

16、brics (Grab Test)D 5587 Test Method for Tearing Strength of Fabrics byTrapezoid ProcedureD 5733 Test Method for Tearing Strength of NonwovenFabrics by the Trapezoid ProcedureD 6701 Test Method for Determining Water Vapor Trans-mission Rates Through Nonwoven and Plastic BarriersF 1494 Terminology Rel

17、ating to Protective ClothingF 1671 Test Method for Resistance of Materials Used inProtective Clothing to Penetration by Blood-Borne Patho-gens Using Phi-X174 Bacteriophage Penetration as a TestSystemF 1868 Test Method for Thermal and Evaporative Resis-tance of Clothing Materials Using a Sweating Hot

18、 Plate2.2 AAMI Documents:3AAMI PB70:2003 Liquid barrier performance and classifi-cation of protective apparel and drapes intended for use inhealthcare facilitiesAAMI ST65:2000 Processing of multiple-use surgical tex-tiles for use in health care facilitiesAAMI TIR11:1994 Selection of Surgical Gowns a

19、ndDrapes in Healthcare FacilitiesAAMI/ANSI BE78:2002 Biological Evaluation of MedicalDevices, Part 10: Test for Irritation and Sensitization2.3 AATCC Standards:4AATCC 42 Water Penetration Resistance: Impact Penetra-tion TestAATCC 127 Water Resistance: Hydrostatic Pressure Test2.4 ANSI/ASQC Standard:

20、5ANSI/ASQC Z1.4 Sampling Procedures and Tables for In-spection by Attributes2.5 ISO Standards:5ISO 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

21、: Lint and other particles generation 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 sterilizationI

22、SO 11135 Medical devicesValidation 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 mo

23、istheat sterilization in healthcare facilities2.6 Federal Standards:616 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

24、Part 1910.1030 Occupational Exposure 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 i

25、nfectious body fluids.3.1.1.1 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

26、 produced, secreted, or ex-creted 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-oti

27、c fluid, saliva in dental procedures, 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

28、, body fluids, and other potentially infectiousmaterials is most likely to occur.3.1.3.1 DiscussionAnnex B of AAMI PB70:2003 pro-vides examples of barrier classification for surgical gownsbased on the critical zone(s). The critical zone can encompassmultiple parts of the garment.3.1.4 critical zone

29、component, nany element, constituent,or item incorporated into the critical 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 characteristic

30、s of a materialthat pertain to its ignition and support of combustion.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

31、 clothing item between use.3Available from the Association for the Advancement of Medical Instrumenta-tion, 110 North Glebe Road, Suite 220, Arlington, VA 22201.4Available from American Association of Textile Chemists and Colorists(AATCC), One Davis Dr., P.O. Box 12215, Research Triangle Park, NC 27

32、709-2215.5Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.6Available from U.S. Government Printing Office Superintendent of Documents,732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401.F24070623.1.7.1 DiscussionIn this specification

33、, multiple-use pro-tective clothing is subject to cleaning (laundering) and steril-ization between each use.3.1.8 other potentially infectious materials, nany materi-als, other than blood or body fluids, containing bloodbornepathogens or materials that have been linked with the potentialtransmission

34、 of 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 Discu

35、ssionExamples of protective clothing in-clude surgical gowns, isolation gowns, decontamination gar-ments, aprons, sleeve protectors, and certain types of labora-tory coats. The primary purpose of the protective clothing is toact as a barrier between the wearer and a hazard. However, theproduct may a

36、lso offer protection as a barrier, which preventsthe 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 ster

37、ilization prior to use per themanufacturers instructions.3.1.11 surgical gown, nprotective clothing that is in-tended to 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, bodyfluid

38、s, and particulate 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 t

39、his test method refer to Terminology F 1494.4. 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 req

40、uiresbarrier testing based on the system of classifying gownsestablished in AAMI PB70:2003 and sets general safety re-quirements for surgical gowns based on biocompatibility,sterility assurance, and flame spread. Documentation andreporting requirements are set for important physical propertiesinclud

41、ing tensile strength, tear resistance, seam strength, lint-ing resistance, 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 cloth

42、ing for the hands, 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 surgi

43、cal boots; or 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

44、efficacy. For 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 informat

45、ion on the processing of multiple-use surgical gowns is provided in AAMI ST65:2000.4.5 While surgical gowns are classified for barrier perfor-mance as specified in AAMI PB70:2003, this specificationestablishes certain other physical performance and documen-tation requirements for surgical gowns and

46、their materials.Design requirements and recommendations are also providedfor surgical gowns.4.6 Additional information for the testing, selection, and useof surgical gowns is provided in AAMI TIR11:1994.NOTE 3Information on barrier classes in AAMI TIR11:1994 does notcurrently match the levels establ

47、ished in AAMI PB70:2003. However,AAMI TIR11:1994 provides other useful information that is intended toaid in the selection and use of surgical gowns.5. Design Requirements5.1 Surgical gowns shall be designed to comply with thebarrier performance requirements of AAMI PB70:2003.5.2 Surgical gowns whic

48、h are intended for reuse shall haveaffixed or attached 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 withAAM

49、I PB70:2003.6. 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 theappropriate evaluations in accordance with AAMI/ANSI BE78:2002. Alternatively, ISO 10993-10 is permitted tobe used.6.2 Sterility assurance level6.2.1 The selected sterilization process for surgical gownsshall have a sterility assurance level of at least 10-6.NOTE 4Appropriate sterilization proce