ASTM_F_2407_-_06_2013e1.pdf

Designation:F240706(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,the 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 protective 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 transmitting 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 engineering 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 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 gownmanufacturers 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 HealthAdministrations 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 areincluded in this specification for reference purposes.NOTE1Some properties require minimum performance and others arefor documentation only.NOTE2AAMI 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 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 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 units 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 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:10.1520/F2407-06R13E01.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 responsibility 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.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 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 Relating 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 Clot