1、Designation:D612406(Reapproved 2011)Standard Test Method forResidual Powder on Medical Gloves1This 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 year of last revision.A numbe
2、r 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.This standard consists of t
3、wo 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 mass)on powdered gloves.1.Sco
4、pe1.1 This test method covers the determination of averagepowder or filter-retained mass found on a sample of medicalgloves as described in the introduction.1.2 The average powder mass per glove is reported inmilligrams.1.3 The safe and proper use of medical gloves is beyond thescope of this test me
5、thod.1.4 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.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 app
6、ro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D4483 Practice for Evaluating Precision for Test MethodStandards in the Rubber and Carbon Black ManufacturingIndustries2.2 Other Documents:American
7、National Standard ANSI/ASQC Z1.91993 Sam-pling Procedures and Tables for Inspection by Variablesfor Percent Nonconforming33.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 medical glovesas used in this test method,refer toboth surgical and examination gloves.3.1.2 powderany water
8、 insoluble,filter-retained residueremaining on the glove after the manufacturing process.3.1.3 powder-freeis also referred to as powderless,nopowder,non-powdered,or words to that effect.4.Significance and Use4.1 This test method is designed to determine the amount ofresidual powder and non-powder so
9、lids found on medicalgloves.4.2 This test method is suitable and designed as a referencemethod to evaluate samples of medical gloves.4.3 The mass found using Procedure II,for powderedgloves,is assumed to be a combination of water-insolubleresidue remaining after the manufacturing process,formerrelea
10、se agents and donning powder.5.Apparatus5.1 Analytical Balance capable of readability and repeat-ability to 0.1 mg.5.2 Reciprocal or Rotator Mechanical Shaker capable of aminimum speed of 1.7 Hz(100 cycles/min).5.3 Gravimetric convection oven.6.Procedure I,for Quantitation of Powder on Powder-free G
11、loves6.1 Powder Test,Powder-Free GlovesTotal Glove:1This test method is under the jurisdiction of Committee D11 on Rubber and isthe direct responsibility of Subcommittee D11.40 on Consumer Rubber Products.Current edition approved Nov.1,2011.Published January 2012.Originallyapproved in 2000.Last prev
12、ious edition approved in 2006 as D6124 06.DOI:10.1520/D6124-06R11.2For 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.
13、3Available from American National Standards Institute,25 W.43rd St.,4thFloor,New York,NY 10036.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 6.1.1 Prior to use,all glassware and tweezers shall be rinsedwith deionized or distilled water.
14、6.2 Filter Preparation:6.2.1 Use a 47 mm,2.7 m pore size glass microfiber filterand a suction filtration apparatus.Use of a TFE-fluorocarbon orequivalent-rimmed housing base is recommended if filtersadhere or tear upon removal from glass-rimmed surface.6.2.2 Insert the filter disk in the filtration
15、apparatus.Applysuction and wash the filter disk with three successive 50 mLportions of deionized or distilled water.Continue suction toremove all traces of water and discard the washings.Removethe filter from the filtration apparatus and transfer it to a rinsedand dried glass petri dish or equivalen
16、t.Dry in an oven at 1006 5C for 1 h.Store the dried filter in a desiccator prior to use.Before use,pre-weigh the dried filter,weighing immediatelyafter removal from the desiccator.6.3 Sample Selection and Test:6.3.1 Randomly select five gloves from each lot to beevaluated.Gently remove glove from original container.6.3.2 Place 500 mL of deionized or distilled water into a1000 mL flask.Water used in this procedure should be at 20 to25C.6.3.3 Place a glove into the beaker/flask with 1 to 3 cm ofth