ASTM D6124-2006(2011) 1875 Standard Test Method for Residual Powder on Medical Gloves《医用手套上残留粉末的标准试验方法》.pdf

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1、Designation: D6124 06 (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.

2、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. This standard

3、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 mass) on

4、powdered gloves.1. Scope1.1 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 th

5、escope of this test method.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

6、 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:2D4483 Practice for Evaluating Precision for Test MethodStandards in the Rubber and Carbon Black ManufacturingIndustries2.

7、2 Other Documents:American 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

8、 gloves.3.1.2 powderany water 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 o

9、fresidual powder and non-powder solids 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 t

10、he manufacturing process, formerrelease 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, fo

11、r Quantitation of Powder on Powder-free Gloves6.1 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 Janu

12、ary 2012. Originallyapproved in 2000. Last previous 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 th

13、e standards Document Summary page onthe ASTM website.3Available from American National Standards Institute, 25 W. 43rd St., 4thFloor, New York, NY 10036.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.6.1.1 Prior to use, all glasswar

14、e and tweezers shall be rinsedwith deionized or distilled water.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 gl

15、ass-rimmed surface.6.2.2 Insert the filter disk in the filtration 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 apparat

16、us and transfer it to a rinsedand dried glass petri dish or equivalent. 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 se

17、lect 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 ofthe cuff area stretched ove

18、r the lip. Hold a portion of the cuffaway from the lip to vent air from the beaker/flask and add250 mL of deionized or distilled water to the inside of theglove, making certain the upper cuff is rinsed as the water ispoured. Additional water may be used if coverage on the gloveexterior is insufficie

19、nt, or as needed for vacant space within theglove. However, space must be adequate to allow agitation.6.3.4 Cap the flask with a rubber stopper or other securecover and agitate for 30 s on a mechanical shaker with aminimum side-to-side or rotational speed of 1.7 Hz (100cycles/min).NOTE 1Securing the

20、 flask at a 45 angle has been noted to improvethe slosh effect and reduce the tendency for twisting at the cuff.6.3.5 Remove the cap and pour the water from the inside ofthe glove into a 600 mL glass beaker. Repeat 6.3.3-6.3.5 withthe remaining four samples using the same 250 mL of watercontained in

21、 the 600 mL glass beaker and the same 500 mL oforiginal water added in 6.3.2.6.3.6 Pour the water from the 600 mL glass beaker and thebeaker/flask through the suction filtration unit containing theweighed filter.6.3.7 Rinse the 600 mL glass beaker with 250 mL ofdeionized or distilled water. Successi

22、vely add the rinse water tothe beaker/flask and into the suction filtration unit containingthe weighed filter.6.3.8 Rinse the beaker/flask, cap, filter housing and anyother portions of the test apparatus that may contain residualpowder to ensure all powder extract is filtered.6.3.9 Continue suction

23、to remove all traces of water anddiscard the washings. Remove the filter from the filtrationapparatus and transfer it to a rinsed and dried glass petri dishor equivalent. Dry in an oven at 100 6 5C for 1 h. Cool in adesiccator for 30 min prior to weighing. Weigh immediatelyafter removal from the des

24、iccator.6.4 Blank ControlUsing a beaker/flask and water identicalto that described in 6.3.2 and filter identical to that described in6.2.1, establish a Blank Control for each of lot of water testedusing the same techniques described above. That is, filter 1000mL of the water. Dry, desiccate, and wei

25、gh the filter asdescribed in 6.2.2.6.5 Calculation of Results:6.5.1 Compute the mass change in the test filter. Subtractany positive mass change of the Blank Control Filter. Thedifference is the accumulated powder residue found for all five(5) gloves in the sample. Divide the total powder mass by fi

26、ve(5) to determine the average mass per glove in milligrams.6.5.2 Report the average powder mass per glove as deter-mined in 6.3.6.6 ReportThe report shall include the type of medicalglove tested, the lot number, and the average powder mass perglove in milligrams.7. Procedure II, for Quantitation of

27、 Powder on PowderedGloves7.1 Powder Test, Powdered GloveTotal Glove:7.1.1 Prior to use, all glassware and tweezers shall be rinsedwith deionized or distilled water.7.2 Filter Preparation:7.2.1 Use a 90 mm, 2.7 m pore size glass microfiber filterand a suction filtration apparatus. Use of a TFE-fluoro

28、carbon orequivalent rimmed housing base is recommended if filtersadhere or tear upon removal from glass rimmed surface.7.2.2 Prepare filter by desiccation a minimum of 30 minprior to use. Before use, pre-weigh the filter, weighing imme-diately after removal from the desiccator.7.3 Sample Selection a

29、nd Test:7.3.1 Randomly select two gloves from each lot to beevaluated. Gently remove glove from original container.7.3.2 Place 500 mL of deionized or distilled water into a1000 mL recessed neck beaker/flask with pouring rim. Allwater used in this procedure should be at or below roomtemperature.7.3.3

30、 Place a glove into the beaker/flask with 1 to 3 cm ofthe cuff area stretched over the lip. Hold a portion of the cuffaway from the lip to vent air from the beaker/flask and add250 mL of deionized or distilled water to the inside of theglove, making certain to rinse the upper cuff as the water ispou

31、red. Additional water may be used if coverage is insuffi-cient on the glove exterior or as needed for vacant space withinthe glove. However, space must be adequate to allow agitation.7.3.4 Cap the beaker/flask with a rubber stopper with apolypropylene rim shroud or equivalent, agitate for 30 s on am

32、echanical shaker with a minimum side to side or rotationalspeed of 1.7 Hz (100 cycles/min).NOTE 2Securing the flask at a 45 angle has been noted to improvethe slosh effect and reduce the tendency for twisting at the cuff.7.3.5 Remove the cap and pour the water from the inside ofthe glove through the

33、 suction filtration unit containing theweighed filter. Remove the glove from the beaker/flask anddrain the remaining inside water from the glove through thesuction filtration unit. Pour the beaker/flask water contentsthrough the suction filtration unit.D6124 06 (2011)27.3.6 Place 500 mL fresh deioni

34、zed or distilled water intothe same 1000 mL recessed neck beaker/flask.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 ofthe cuff away from the lip to vent air from the beaker/flask andadd 250 mL of fresh deionized or distilled

35、 water to the insideof the glove. Additional water may be used if coverage isinsufficient. However, space must be adequate to allow agita-tion.7.3.8 Cap the beaker/flask with the same rubber stopperwith a polypropylene rim shroud or equivalent, agitate for 30 son a mechanical shaker with a minimum s

36、peed of 1.7 Hz (100cycles/minute).7.3.9 Remove the cap and pour the water from the inside ofthe glove through the suction filtration unit containing theweighed filter. Remove the glove from the beaker/flask anddrain the remaining inside water from the glove through thesuction filtration unit. Pour t

37、he beaker/flask water contentsthrough the suction filtration unit.7.3.10 Repeat 7.3.6-7.3.9 on the same glove for an addi-tional two fresh water rinses, constituting a total of four freshwater rinses per single glove.7.3.11 Rinse the beaker/flask, cap, filter housing and anyother portions of the tes

38、t apparatus that may contain residualpowder to ensure all powder extract is filtered.7.3.12 Repeat 7.3-7.3.11 for the second glove, utilizing thesame filter and suction device used for the first glove. Only two(2) gloves shall be evaluated per filter.7.3.13 Continue suction to remove all traces of w

39、ater anddiscard the washings. Remove the filter from the filtrationapparatus and transfer it to a rinsed and dried glass petri dishor equivalent. Dry in an oven at 100 6 5C for 1 h. Cool in adesiccator for a minimum of 30 min prior to weighing. Weighimmediately after desiccation to prevent moisture

40、absorption.7.4 Calculation of Results:7.4.1 Compute the mass change in the test filter. Thedifference is the accumulated powder residue found for the twogloves in the sample. Divide the total powder mass by two (2)to determine the average mass per glove in milligrams.7.4.2 Report the average powder

41、mass per glove as deter-mined in 7.3.7.5 Interpretaton of Results:7.5.1 A result of average powder mass less than or equal to90 % of the recommended maximum limit will allow imme-diate acceptance.7.5.2 A result of average powder mass greater than 5 %above the recommended maximum limit will be consid

42、ered afailure.7.5.3 A result of average powder mass that exceeds 90 % ofthe recommended maximum limit, but that is less than or equalto 105 % of the recommended maximum limit may be retestedas follows:7.5.3.1 Randomly select two sets of two gloves from the lotto be retested.7.5.3.2 Test each set of

43、two gloves according to 7.1.7.5.3.3 Calculate the arithmetic mean of the results from7.5.3 and 7.5.3.2.7.5.3.4 A calculated arithmetic mean is acceptable if:(a) The quantity U 2 X!/s equals or exceeds the acceptabil-ity constant (k) as follows:U2X!/s$k 5 0.34where:n = sample size=3(3sets of 2 gloves

44、),s = standard deviation of the sample (three determina-tions),X = mean of the sample (three determinations), andU = recommended maximum limit.NOTE 3The acceptability constant (k) is obtained from Table B-2 ofANSI/ASQC Z1.993 in Section B, Part 1.7.6 Report:7.6.1 The report shall include the type of

45、 medical glovetested, the lot number, and the average powder mass per glovein milligrams.7.6.2 Results of any retest shall be included according to (a)from 7.5.3.4, and a statement whether the result is acceptableor not acceptable.8. Precision and Bias8.1 The precision and bias section has been prep

46、ared inaccordance with Practice D4483. Refer to Practice D4483 forterminology and other statistical details.8.2 The precision results in this precision and bias sectiongive an estimate of the precision of these test methods with thematerials used in the particular interlaboratory program asdescribed

47、 below. The precision parameters should not be usedfor acceptance/rejection testing of any group of materialswithout documentation that the parameters are applicable tothose particular materials and the specific testing protocols thatinclude these test methods.8.3 Procedure for quantitation of powde

48、r on powder-freegloves.8.3.1 A Type 1 precision was evaluated in 1999. Bothrepeatability and reproducibility are short term. A period of afew days separates replicate test results. Test result is the meanvalue, as specified by this test method, obtained on twodetermination(s) or measurements(s) of t

49、he property or param-eter in question.8.3.2 Three powder-free glove types in Procedure I andthree powdered glove types in Procedure II were used in thisinterlaboratory program. Testing was performed in sevenlaboratories.8.3.3 For Procedure I, Quantitation of Powder on Powder-free Gloves, one lot of powder-free synthetic examinationgloves, one lot of powder-free latex surgical gloves, and one lotof powder-free latex examination gloves were utilized.8.3.4 For Procedure II, Quantitation of Powder on Pow-dered Gloves, one lot of powdered synthetic examinationgloves