1、This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations isued by the World Trade Organization Technical Barriers to Trade(T
2、BT)Committee.Designation:D6124-06(Reapproved 2017)INTERNATIONALStandard Test Method forResidual Powder on Medical GlovesThis standard is issued under the fixed designation D6124;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the yea
3、r 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.INTRODUCTIONThis standard is designed to determine the amount of residual powder(or filter-retained mass)foundon medical gloves.T
4、his standard consists of two test methodologies.Procedure I is a method for thequantification of residual powder on gloves described as non-powdered,powder-free,powderless,nopowder,or other words to that effect.Procedure II is a test method for the quantitation of powder(andother filter-retained mas
5、s)on powdered gloves.1.ScopeD4483 Practice for Evaluating Precision for Test Method1.1 This test method covers the determination of averageStandards in the Rubber and Carbon Black Manufacturingpowder or filter-retained mass found on a sample of medicalIndustriesgloves as described in the introductio
6、n.2.2 Other Documents:American National Standard ANSI/ASQC Z1.9-1993 Sam-1.2 The average powder mass per glove is reported inpling Procedures and Tables for Inspection by Variablesmilligrams.for Percent Nonconforming1.3 The safe and proper use of medical gloves is beyond thescope of this test method
7、.3.Terminology1.4 The values stated in SI units are to be regarded as3.1 Definitions of Terms Specific to This Standard:standard.No other units of measurement are included in this3.1.1 medical gloves-as used in this test method,refer tostandard.both surgical and examination gloves.1.5 This standard
8、does not purport to address all of the3.1.2 powder-any water insoluble,filter-retained residuesafety concerns,if any,associated with its use.It is theremaining on the glove after the manufacturing process.responsibility of the user of this standard to establish appro-3.1.3 powder-free-is also referr
9、ed to as powderless,nopriate safety and health practices and determine the applica-powder,non-powdered,or words to that effect.bility of regulatory limitations prior to use.1.6 This international standard was developed in accor-4.Significance and Usedance with internationally recognized principles o
10、n standard-4.1 This test method is designed to determine the amount ofization established in the Decision on Principles for theresidual powder and non-powder solids found on medicalDevelopment of International Standards,Guides and Recom-gloves.mendations issued by the World Trade Organization Techni
11、calBarriers to Trade(TBT)Committee.4.2 This test method is suitable and designed as a referencemethod to evaluate samples of medical gloves.2.Referenced Documents4.3 The mass found using Procedure II,for powdered2.1 ASTM Standards:2gloves,is assumed to be a combination of water-insolubleresidue rema
12、ining after the manufacturing process,formerrelease agents and donning powder.This test method is under the jurisdiction of Committee D11 on Rubber andRubber-like Materials and is the direct responsibility of Subcommittee D11.40 onConsumer Rubber Products.5.ApparatusCurrent edition approved May 1,20
13、17.Published July 2017.Originally approved5.1 Analytical Balance capable of readability and repeat-in 2000.Last previous edition approved in 2011 as D6124-06(2011).DOI:10.1520/D6124-06R17.ability to 0.1 mg.2 For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Se
14、rvice at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page on3 Available from American National Standards Institute,25 W.43rd St.,4ththe ASTM website.Floor,New York,NY 10036.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,
15、West Conshohocken,PA 19428-2959.United StatesCopyright by ASTM Intl(all rights reserved);Sat Sep 30 12:37:11 EDT 2017 1Downloaded/printed byUniversity of Edinburgh(University of Edinburgh)pursuant to License Agreement.No further reproductions authorized.D6124-06(2017)5.2 Reciprocal or Rotator Mechan
16、ical Shaker capable of a6.3.8 Rinse the beaker/flask,cap,filter housing and anyminimum speed of 1.7 Hz(100 cycles/min).other portions of the test apparatus that may contain residual5.3 Gravimetric convection oven.powder to ensure all powder extract is filtered.6.3.9 Continue suction to remove all tr
17、aces of water and6.Procedure I,for Quantitation of Powder on Powder-discard the washings.Remove the filter from the filtrationfree Glovesapparatus and transfer it to a rinsed and dried glass petri dishor equivalent.Dry in an oven at 100 5C for 1 h.Cool in a6.1 Powder Test,Powder-Free Gloves-Total Gl
18、ove:desiccator for 30 min prior to weighing.Weigh immediately6.1.1 Prior to use,all glassware and tweezers shall be rinsedafter removal from the desiccator.with deionized or distilled water.6.4 Blank Control-Using a beaker/flask and water identical6.2 Filter Preparation:to that described in 6.3.2 an
19、d filter identical to that described in6.2.1 Use a 47 mm,2.7 um pore size glass microfiber filter6.2.1,establish a Blank Control for each of lot of water testedand a suction filtration apparatus.Use of a TFE-fluorocarbon orusing the same techniques described above.That is,filter 1000equivalent-rimme
20、d housing base is recommended if filtersmL of the water.Dry,desiccate,and weigh the filter asadhere or tear upon removal from glass-rimmed surface.described in6.2.2.6.2.2 Insert the filter disk in the filtration apparatus.Apply6.5 Calculation of Results:suction and wash the filter disk with three su
21、ccessive 50 mL6.5.1 Compute the mass change in the test filter.Subtractportions of deionized or distilled water.Continue suction toany positive mass change of the Blank Control Filter.Theremove all traces of water and discard the washings.Removedifference is the accumulated powder residue found for
22、all fivethe filter from the filtration apparatus and transfer it to a rinsed(5)gloves in the sample.Divide the total powder mass by fiveand dried glass petri dish or equivalent.Dry in an oven at 100(5)to determine the average mass per glove in milligrams.5C for 1 h.Store the dried filter in a desicc
23、ator prior to use.6.5.2 Report the average powder mass per glove as deter-Before use,pre-weigh the dried filter,weighing immediatelymined in 6.3.after removal from the desiccator.6.6 Report-The report shall include the type of medical6.3 Sample Selection and Test:glove tested,the lot number,and the
24、average powder mass per6.3.1 Randomly select five gloves from each lot to beglove in milligrams.evaluated.Gently remove glove from original container.7.Procedure II,for Quantitation of Powder on Powdered6.3.2 Place 500 mL of deionized or distilled water into aGloves1000 mL flask.Water used in this p
25、rocedure should be at 20 to25.7.1 Powder Test,Powdered Glove-Total Glove:7.1.1 Prior to use,all glassware and tweezers shall be rinsed6.3.3 Place a glove into the beaker/flask with 1 to 3 cm ofthe cuff area stretched over the lip.Hold a portion of the cuffwith deionized or distilled water.away from
26、the lip to vent air from the beaker/flask and add7.2 Filter Preparation:250 mL of deionized or distilled water to the inside of the7.2.1 Use a 90 mm,2.7 um pore size glass microfiber filterglove,making certain the upper cuff is rinsed as the water isand a suction filtration apparatus.Use of a TFE-fl
27、uorocarbon orpoured.Additional water may be used if coverage on the gloveequivalent rimmed housing base is recommended if filtersexterior is insufficient,or as needed for vacant space within theadhere or tear upon removal from glass rimmed surface.glove.However,space must be adequate to allow agitat
28、ion.7.2.2 Prepare filter by desiccation a minimum of 30 min6.3.4 Cap the flask with a rubber stopper or other secureprior to use.Before use,pre-weigh the filter,weighing imme-cover and agitate for 30 s on a mechanical shaker with adiately after removal from the desiccator.minimum side-to-side or rot
29、ational speed of 1.7 Hz(1007.3 Sample Selection and Test:cycles/min).7.3.1 Randomly select two gloves from each lot to beevaluated.Gently remove glove from original container.NoTE 1-Securing the flask at a 45 angle has been noted to improvethe slosh effect and reduce the tendency for twisting at the
30、 cuff.7.3.2 Place 500 mL of deionized or distilled water into a1000 mL recessed neck beaker/flask with pouring rim.All6.3.5 Remove the cap and pour the water from the inside ofwater used in this procedure should be at or below roomthe glove into a 600 mL glass beaker.Repeat 6.3.3-6.3.5 withtemperatu
31、re.the remaining four samples using the same 250 mL of water7.3.3 Place a glove into the beaker/flask with 1 to 3 cm ofcontained in the 600 mL glass beaker and the same 500 mL ofthe cuff area stretched over the lip.Hold a portion of the cufforiginal water added in 6.3.2.away from the lip to vent air
32、 from the beaker/flask and add6.3.6 Pour the water from the 600 mL glass beaker and the250 mL of deionized or distilled water to the inside of thebeaker/flask through the suction filtration unit containing theglove,making certain to rinse the upper cuff as the water isweighed filter.poured.Additiona
33、l water may be used if coverage is insuffi-6.3.7 Rinse the 600 mL glass beaker with 250 mL ofcient on the glove exterior or as needed for vacant space withindeionized or distilled water.Successively add the rinse water tothe glove.However,space must be adequate to allow agitation.the beaker/flask an
34、d into the suction filtration unit containing7.3.4 Cap the beaker/flask with a rubber stopper with athe weighed filter.polypropylene rim shroud or equivalent,agitate for 30 s on aCopyright by ASTM Intl(all rights reserved);Sat Sep 30 12:37:11 EDT 20172Downloaded/printed byUniversity of Edinburgh(Uni
35、versity of Edinburgh)pursuant to License Agreement.No further reproductions authorized.D6124-06(2017)mechanical shaker with a minimum side to side or rotational7.5.3 A result of average powder mass that exceeds 90%ofspeed of 1.7 Hz(100 cycles/min).the recommended maximum limit,but that is less than
36、or equalNoTE 2-Securing the flask at a 45 angle has been noted to improveto 105%of the recommended maximum limit may be retestedthe slosh effect and reduce the tendency for twisting at the cuff.as follows:7.3.5 Remove the cap and pour the water from the inside of7.5.3.1 Randomly select two sets of t
37、wo gloves from the lotthe glove through the suction filtration unit containing theto be retested.weighed filter.Remove the glove from the beaker/flask and7.5.3.2 Test each set of two gloves according to 7.1.drain the remaining inside water from the glove through the7.5.3.3 Calculate the arithmetic m
38、ean of the results fromsuction filtration unit.Pour the beaker/flask water contents7.5.3 and7.5.3.2.through the suction filtration unit.7.5.3.4 A calculated arithmetic mean is acceptable if:7.3.6 Place 500 mL fresh deionized or distilled water into(a)The quantity(U-x)/s equals or exceeds the accepta
39、bilitythe same 1000 mL recessed neck beaker/flask.constant(k)as follows:7.3.7 Replace the test glove into the same beaker/flask with1 to 3 cm of the cuff stretched over the lip.Hold a portion of(U-x)sk=0.34the cuff away from the lip to vent air from the beaker/flask andwhere:add 250 mL of fresh deio
40、nized or distilled water to the insiden=sample size=3(3 sets of 2 gloves).of the glove.Additional water may be used if coverage iss=standard deviation of the sample(three determinations),insufficient.However,space must be adequate to allow agita-x=mean of the sample(three determinations),andtion.U=r
41、ecommended maximum limit.7.3.8 Cap the beaker/flask with the same rubber stopperNoTE 3-The acceptability constant(k)is obtained from Table B-2 ofwith a polypropylene rim shroud or equivalent,agitate for 30 sANSI/ASQC Z1.9-93 in Section B.Part 1.on a mechanical shaker with a minimum speed of 1.7 Hz(1
42、007.6 Report:cycles/minute).7.6.1 The report shall include the type of medical glove7.3.9 Remove the cap and pour the water from the inside oftested,the lot number,and the average powder mass per glovethe glove through the suction filtration unit containing thein milligrams.weighed filter.Remove the
43、 glove from the beaker/flask and7.6.2 Results of any retest shall be included according to(a)drain the remaining inside water from the glove through thefrom 7.5.3.4,and a statement whether the result is acceptablesuction filtration unit.Pour the beaker/flask water contentsor not acceptable.through t
44、he suction filtration unit.7.3.10 Repeat 7.3.6-7.3.9 on the same glove for an8.Precision and Biasadditional two fresh water rinses,constituting a total of fourfresh water rinses per single glove.8.1 The precision and bias section has been prepared in7.3.11 Rinse the beaker/flask,cap,filter housing a
45、nd anyaccordance with Practice D4483.Refer to Practice D4483 forother portions of the test apparatus that may contain residualterminology and other statistical details.powder to ensure all powder extract is filtered.8.2 The precision results in this precision and bias section7.3.12 Repeat 7.3-7.3.11
46、 for the second glove,utilizing thegive an estimate of the precision of these test methods with thesame filter and suction device used for the first glove.Only twomaterials used in the particular interlaboratory program as(2)gloves shall be evaluated per filter.described below.The precision paramete
47、rs should not be used7.3.13 Continue suction to remove all traces of water andfor acceptance/rejection testing of any group of materialsdiscard the washings.Remove the filter from the filtrationwithout documentation that the parameters are applicable toapparatus and transfer it to a rinsed and dried
48、 glass petri dishthose particular materials and the specific testing protocols thator equivalent.Dry in an oven at 100 5C for 1 h.Cool in ainclude these test methods.desiccator for a minimum of 30 min prior to weighing.Weigh8.3 Procedure for quantitation of powder on powder-freeimmediately after des
49、iccation to prevent moisture absorption.gloves.7.4 Calculation of Results:8.3.1 A Type 1 precision was evaluated in 1999.Both7.4.1 Compute the mass change in the test filter.Therepeatability and reproducibility are short term.A period of adifference is the accumulated powder residue found for the tw
50、ofew days separates replicate test results.Test result is the meangloves in the sample.Divide the total powder mass by two(2)value,as specified by this test method,obtained on twoto determine the average mass per glove in milligrams.determination(s)or measurements(s)of the property or param-7.4.2 Re
51、port the average powder mass per glove as deter-eter in question.mined in 7.3.8.3.2 Three powder-free glove types in Procedure I and7.5 Interpretaton of Results:three powdered glove types in Procedure II were used in this7.5.1 A result of average powder mass less than or equal tointerlaboratory prog
52、ram.Testing was performed in seven90%of the recommended maximum limit will allow imme-laboratories.diate acceptance.8.3.3 For Procedure I,Quantitation of Powder on Powder-7.5.2 A result of average powder mass greater than 5%free Gloves,one lot of powder-free synthetic examinationabove the recommende
53、d maximum limit will be considered agloves,one lot of powder-free latex surgical gloves,and one lotfailure.of powder-free latex examination gloves were utilized.Copyright by ASTM Intl(all rights reserved);Sat Sep 30 12:37:11 EDT 20173Downloaded/printed byUniversity of Edinburgh(University of Edinbur
54、gh)pursuant to License Agreement.No further reproductions authorized.D6124-06(2017)8.3.4 For Procedure II,Quantitation of Powder on Pow-in Tables 1 and 2.Two single test results obtained in twodered Gloves,one lot of powdered synthetic examinationdifferent laboratories,under normal test method proce
55、dures,gloves,one lot of powdered latex surgical gloves,and one lotthat differ by more than the tabulated R(for any given level)of powdered latex examination gloves were utilized.must be considered to have come from different or nonidentical8.3.5 The results of the precision calculations for repeatab
56、il-sample populations.ity and reproducibility are given in Tables 1 and 2,in ascending8.3.9 Repeatability and reproducibility expressed as a per-order of powder average or level,for each of the materialscentage of the mean level,(r)and(R),have equivalentevaluated.8.3.6 The precision of this test met
57、hod may be expressed inapplication statements as above for r and R.For the(r)and(R)the format of the following statements that use what is calledstatements,the difference in the two single test results isan appropriate value of r,R,(r),or(R).That is,that value toexpressed as a percentage of the arit
58、hmetic mean of the two testbe used in decisions about test results(obtained with the testresults.method).The appropriate value is that value of r or R8.3.10 Bias-In test method terminology,bias is the differ-associated with a mean level in Tables I and 2 closest to theence between an average test va
59、lue and the reference(or true)mean level under consideration at any given time,for anytest property value.Reference values do not exist for this testgiven material in routine testing operations.method since the value(of the test property)is exclusively8.3.7 Repeatability-The repeatability,r,of this
60、test methoddefined by the test method.Bias,therefore,cannot be deter-has been established as the appropriate value tabulated inmined.Tables 1 and 2.Two single test results,obtained under normaltest method procedures,that differ by more than this tabulated9.Keywordsr(for any given level)must be consi
61、dered as derived from9.1 detection;filter;gloves;medical;powder;powder-free;different or nonidentical sample populations.8.3.8 Reproducibility-The reproducibility,R,of this testquantitationmethod has been established as the appropriate value tabulatedTABLE 1 Procedure I-Quantitation of Powder on Pow
62、der-Free GlovesWithin LaboratoriesBetween LaboratoriesMaterialAverageSrr(1)SRR(F)1.Powder-free Latex Exam0.200.050.21105%0.090.26130%2.Powder-free Latex Surgical0.350.040.1337%0.130.36103%3.Powder-free Synthetic Exam0.630.130.3657%0.190.5282%Sr=repeatability standard deviation=repeatability=2.83 tim
63、es the square root of the repeatability variance(r)=repeatability(as percentage of material average)SR=reproducibility standard deviationR=reproducibility=2.83 times the square root of the reproducibility variance(R)=reproducibility(as percentage of material average)Expressed in milligrams.Copyright
64、 by ASTM Intl(all rights reserved);Sat Sep 30 12:37:11 EDT 20174Downloaded/printed byUniversity of Edinburgh(University of Edinburgh)pursuant to License Agreement.No further reproductions authorized.4D6124-06(2017)TABLE 2 Procedure ll-Quantitation of Powder on Powdered GlovesWithin LaboratoriesBetwe
65、en LaboratoriesMaterialAverageSrSR91.Powdered Latex Surgical1092119%267165%2.Powdered Latex Exam180102816%277542%3.Powdered Synthetic Surgical222226228%287828%Srrepeatability standard deviationrepeatability=2.83 times the square root of the repeatability variancerepeatability(as percentage of materi
66、al average)SR reproducibility standard deviationRreproducibility=2.83 times the square root of the reproducibility varianceRreproducibility(as percentage of material average)AExpressed in milligrams.ASTM Intemational takes no position respecting the validity of any patent rights asserted in connecti
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