ASTM_D_6978_-_05_2013.pdf

Designation:D697805(Reapproved 2013)Standard Practice forAssessment of Resistance of Medical Gloves to Permeationby Chemotherapy Drugs1This standard is issued under the fixed designation D6978;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.1.Scope1.1 This practice covers a protocol for the assessment ofresistance of medical glove materials to permeation by poten-tially hazardous cancer chemotherapy drugs under conditionsof continuous contact.An assessment is made based on thepermeation(breakthrough)of nine chemotherapy drugsthrough the glove material over a certain period of time.1.2 It is emphasized that the conditions used in this assess-ment are intended to approximate the worst-case condition forclinical uses.The data should be restricted to use on a relativebasis when comparing glove materials.1.3 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 regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D471 Test Method for Rubber PropertyEffect of LiquidsD3577 Specification for Rubber Surgical GlovesD3578 Specification for Rubber Examination GlovesD3767 Practice for RubberMeasurement of DimensionsD5250 Specification for Poly(vinyl chloride)Gloves forMedical ApplicationD6319 Specification for Nitrile Examination Gloves forMedical ApplicationD6977 Specification for Polychloroprene ExaminationGloves for Medical ApplicationF739 Test Method for Permeation of Liquids and Gasesthrough Protective Clothing Materials under Conditions ofContinuous Contact3.Terminology3.1 Definitions:3.1.1 See Test Method F739,Section 3 on Terminology fora full list of terms and definitions.3.1.2 breakthrough detection time,nthe time in minutesmeasured from the start of the test to the sampling time thatimmediately precedes the sampling time at which the perme-ation rate reaches 0.01 g/cm2/min.See Test Method F739,section 12.4.2 for calculation of permeation rate with replen-ishment.3.1.3 validated statistical rationale,n requires that anobjective cause or reason be stated as to why the initial test wasincorrect.4.Significance and Use4.1 The objective of this practice is to provide a uniformprocedure for assessing the resistance of medical glove mate-rials to permeation by chemotherapy drugs,and to establish aconsistent reporting of the test data.5.Test Protocol5.1 Summary of Test Method:5.1.1 The gloves in question shall be tested in accordancewith the method set out in Test Method F739,Procedure A.5.1.2 The resistance of a medical glove material to perme-ation by chemotherapy drugs shall be determined by measuringthe breakthrough detection time of the drugs through the glovematerial.The test method involves using the test material serveas a membrane(partition)between the two halves of a test cell.One half of the cell shall contain the donor solution of the testdrug and the other half shall contain the appropriate collectionmedium,that is,distilled water or other liquid,which does notinfluence the permeation of the drug being tested.A test drugpermeates through the sample material when the test drug isable to pass through the test material.As the test drugcontinuously passes through the sample material,its concen-tration increases over time.The collection medium shall besampled at recorded time intervals and analyzed quantitativelyto determine the concentration of the permeated drug.Theconcentration of the drug in the collection medium shall beused to calculate the breakthrough detection time and perme-ation rate(see 3.1.3),in accordance with Test Method F739.1This practice is under the jurisdiction ofASTM Committee D11 on Rubber andis the direct responsibility of Subcommittee D11.40 on Consumer Rubber Products.Current edition approved Jan.1,2013.Published April 2013.Originallyapproved in 2005.Last previous edition approved in 2005 as D6978 05.DOI:10.1520/D6978-05R13.2For 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 5.2 Test Protocol:5.2.1 Test Material Selection:5.2.1.1 Three medical gloves that meet the appropriateASTM standards(Specifications D3577,D3578,D5250,D6319,and D6977)shall be selected and used to produce testsamples.Manually measure each glove thickness with athickness gage that has a presser foot pressure that meets therequirement of Practice D3767,and graduations to 20 m.Foreac