ASTM D7198-2005(2012) 8750 Standard Specification for Disposable Embalming Gloves for Single-Use Applications《一次性防腐手套的标准规范》.pdf

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1、Designation: D7198 05 (Reapproved 2012)Standard Specification forDisposable Embalming Gloves for Single-Use Applications1This standard is issued under the fixed designation D7198; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the

2、 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 specification covers certain requirements for natu-ral rubber (Latex), synthetic rubber (Polychloroprene

3、 andNitrile), and vinyl (PVC) disposable gloves for use in conduct-ing single-use embalming procedures.1.2 This specification covers natural rubber (Latex), syn-thetic rubber (Polychloroprene and Nitrile), and Vinyl (PVC)disposable gloves that fit either hand, paired gloves, gloves bysize, and glove

4、s packed in bulk.1.3 An assessment to measure the chemical resistanceperformance of the glove can be made based on the ultimatepermeation (breakthrough) of embalming chemicals throughthe glove material over a specified period of time.1.4 This specification is similar to the following specifica-tions

5、: D3578, D4679, D5250, D6319, and D6977.1.5 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.1.6 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the

6、 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:2D412 Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD573 Test Method for RubberDeter

7、ioration in an AirOvenD3578 Specification for Rubber Examination GlovesD3767 Practice for RubberMeasurement of DimensionsD4679 Specification for Rubber General Purpose, House-hold or Beautician GlovesD5151 Test Method for Detection of Holes in MedicalGlovesD5250 Specification for Poly(vinyl chloride

8、) Gloves forMedical ApplicationD5712 Test Method for Analysis of Aqueous ExtractableProtein in Natural Rubber and Its Products Using theModified Lowry MethodD6124 Test Method for Residual Powder on Medical GlovesD6319 Specification for Nitrile Examination Gloves forMedical ApplicationD6499 Test Meth

9、od for The Immunological Measurement ofAntigenic Protein in Natural Rubber and its ProductsD6977 Specification for Polychloroprene ExaminationGloves for Medical ApplicationF739 Test Method for Permeation of Liquids and Gasesthrough Protective Clothing Materials under Conditions ofContinuous Contact2

10、.2 ISO Standard:ISO 2859 Sampling Procedures and Tables for Inspection byAttributes32.3 Other Document:U.S. Pharmacopeia43. Significance and Use3.1 This specification is intended to be a specification forevaluating the performance and quality of disposable naturalrubber, synthetic rubber, and vinyl

11、(PVC) gloves for single-useembalming applications.3.2 The safe and proper use of disposable natural rubber,synthetic rubber (polychloroprene and nitrile), and vinyl glovesis beyond the scope of this specification.3.3 The chemical permeation tests described in this speci-fication are intended to be “

12、Type Tests” for these types ofgloves.3.3.1 The chemical permeation tests are not intended to betesting instructions nor testing protocols to be used for routinelot release.1This specification is under the jurisdiction ofASTM Committee D11 on Rubberand is the direct responsibility of Subcommittee D11

13、.40 on Consumer RubberProducts.Current edition approved Dec. 1, 2012. Published February 2013. Originallyapproved in 2005. Last previous edition approved in 2005 as D7198 05. DOI:10.1520/D7198-05R12.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service

14、 at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.4U. S. Pharmacopeia, latest edition, Mack Publishing Co

15、., Easton, PA 19175.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States14. Materials and Manufacture4.1 Any natural rubber, synthetic rubber, and plastic poly-mer compound may be used that permits the glove to meet therequirements of this

16、 specification.4.2 A lubricant that meets the current requirements of theU.S. Pharmacopoeia for absorbable dusting powder may beapplied to the glove. Other lubricants may be used if theirsafety and efficacy have been previously established.4.3 The inside and outside surface of the natural rubber,syn

17、thetic rubber, and plastic disposable gloves shall be free oftalc.5. Sampling5.1 For referee purposes, gloves shall be sampled fromfinished product and inspected in accordance with ISO 2859.The inspection levels and acceptable quality levels (AQL) shallconform to those specified in Table 1, or as ag

18、reed uponbetween the purchaser and the seller, if the latter is morecomprehensive.6. Performance Requirements6.1 Gloves shall be sampled in accordance with Section 5.6.2 Gloves shall meet the referee performance requirementsas described in Table 1.6.2.1 Shall comply with freedom from holes when test

19、ed inaccordance with 7.2.6.2.2 Have consistent physical dimensions in accordancewith 7.3.6.2.3 Have acceptable physical property characteristics inaccordance with 7.4.6.2.4 Powder-free gloves shall have a recommended maxi-mum powder residue limit of 2.0 mg per glove in accordancewith 7.5 and A2.1.6.

20、2.5 Powdered gloves shall have a recommended maxi-mum powder limit of 10 mg/dm2in accordance with 7.6 andA2.2.6.2.6 Have a recommended aqueous soluble protein contentlimit of 200 g/dm2in accordance with 7.7 and Annex A1 orhave a recommended antigenic protein content limit of 10g/dm2in accordance wit

21、h 7.8 and Annex A3.7. Test Methods7.1 The following tests shall be conducted to ensure therequirements of Section 8 are met, as prescribed in Table 1.7.2 Freedom from HolesTesting for freedom from holesshall be conducted in accordance with Test Method D5151.7.3 Physical Dimensions Test:7.3.1 The glo

22、ves shall comply with the dimension require-ments prescribed in Tables 2-4.7.3.2 The length shall be expressed in millimeters as mea-sured from the outside tip of the middle finger to the outsideedge of the cuff.7.3.3 The width of the palm shall be expressed in millime-ters as measured at a level be

23、tween the base of the index fingerand the base of the thumb. Values of width per size other thanlisted shall meet the stated tolerance specified in Tables 2-4.7.3.4 The minimum finger, palm, and cuff thicknesses shallbe expressed in millimeters as specified in Tables 2-4 whenusing a dial or digital

24、micrometer that meets requirementsdescribed in Test Methods D412 and Practice D3767, and inthe locations indicated in Fig. 1. For referee tests, cutting theglove is necessary to obtain single-wall thickness measure-ments. (See Practice D3767 for more information.)7.4 Physical Requirements Test:7.4.1

25、 Before and after accelerated aging, the gloves shallconform to the physical requirements specified in Tables 5-9.Tests shall be conducted in accordance with Test MethodsD412.7.4.2 Accelerated AgingThe gloves shall be aged in ac-cordance with Test Method D573. Test the gloves in accor-dance with the

26、 following methods:7.4.3 After being subjected to a temperature of 70 6 2C for166 6 2 h, the tensile strength and ultimate elongation shall notbe less than the values specified in Tables 5-9. This methodshall be the conditions for referee tests.7.4.4 Or, after being subjected to a temperature of 100

27、 62C for 22 6 0.3 h (if validated by manufacturer), the tensilestrength and ultimate elongation shall not be less than thevalues specified in Tables 5-9.7.5 Powder Free Gloves:7.5.1 Determine the powder residue for powder-free glovesusing Test Method D6124.7.5.2 The powder residue shall not exceed t

28、he recom-mended average powder mass referenced in A2.1 when testedin accordance with Test Method D6124 for powder-free gloves.7.6 Powdered Gloves:7.6.1 Determine the powder amount for powdered glovesusing Test Method D6124.7.6.2 The powder amount shall not exceed the recom-mended average powder mass

29、 referenced in A2.2 when testedin accordance with Test Method D6124 for powdered gloves.7.6.3 Determine the square decimeters for the glove size asdescribed in section 7.7.3 or 7.7.3.1.TABLE 1 Quality Performance and Barrier PropertyRequirements: Natural Rubber (Latex), Synthetic Rubber(Polychloropr

30、ene and Nitrile), and Vinyl (PVC)Characteristic Related DefectsInspectionLevelAQLFreedom from holes holes G-1 2.5Dimensions width, length, thickness S-2 4.0Physical properties before aging, afteraccelerated agingS-2 4.0Powder-free residue exceeds recommendedmaximum limit perAnnex A2.1N=5 N/APowder a

31、mount exceeds recommendedmaximum limit perAnnex A2.2N=2 N/AProtein content(Latex only)exceeds recommendedmaximum limit perAnnex A1N=3 N/AAntigenic protein(Latex only)exceeds recommendedmaximum limit perAnnex A3N=1 N/APermeation steady-state is reachedmaximum rate is reachedpermeation at increased ra

32、teN=3 N/AD7198 05 (2012)27.7 Aqueous Extractable Protein Content:7.7.1 Determine the aqueous extractable protein (g/mL)using Test Method D5712 for each glove sample tested.7.7.2 Determine the total g of aqueous extractable proteinin each glove sample by multiplying the result from 7.7.1 bythe total

33、volume of extractable used for that specific glovesample. If the glove sample is less than a whole glove, thenadjust the protein results to reflect the amount of protein in thewhole glove.7.7.3 Determine the surface area for each glove sampletested, by size, in square decimeters. To do so, multiply

34、theactual length (mm) and actual width (mm) found on each gloveand convert to dm2using the following equation: (dm2/mm2)(mm2/10 000). Four (4) is the factor for all inside and outsidesurface areas.7.7.3.1 The applied surface area by glove size shall bedetermined by taking the average surface areas o

35、f the glovesmeasured by size.7.7.4 Determine the aqueous extractable protein content of aglove sample by dividing the result from 7.7.2 (total of g ofProtein) by 7.7.3 (total surface area of the glove.)7.7.5 If the sample is more than one (1) glove, use theaverage g/dm2of protein for the number of g

36、loves tested inthe sample.TABLE 2 Dimensions and Tolerances: Natural Rubber (Latex)NOTE 1Sizing that falls within the tolerance overlaps between two sizes may be labeled as a size range including both sizes, for example,small/medium and medium/large.DesignationSizeTolerance,mm6612 7712 8812 9Width b

37、y size, mm 75 83 89 95 102 108 114 6Width by label, X-small small Unisize medium large X-large XX-largemm 70 80 85 95 110 120 130 10Length 240 240 240 240 240 240 240 MinThickness, mm For All SizesFinger 0.08 MinPalm 0.08 MinCuff 0.08 MinTABLE 3 Dimensions and Tolerances: Synthetic Rubber (Polychlor

38、oprene and Nitrile)NOTE 1Sizing that falls within the tolerance overlaps between two sizes may be labeled as a size range including both sizes, for example,small/medium and medium/large.DesignationSizeTolerance,mm6612 7712 8812 9Width by size, mm 75 83 89 95 102 108 114 6Width by label, X-small smal

39、l Unisize medium large X-large XX-largemm 70 80 85 95 110 120 130 10Length 240 240 240 240 240 240 240 MinThickness, mm For All SizesFinger 0.05 MinPalm 0.05 MinCuff 0.05 MinTABLE 4 Dimensions and Tolerances: Vinyl (PVC)NOTE 1Sizing that falls within the tolerance overlaps between two sizes may be l

40、abeled as a size range including both sizes, for example,small/medium and medium/large.DesignationSizeTolerance,mm6612 7712 8812 9Width by size, mm 75 83 89 95 102 108 114 6Width by label, X-small small Unisize medium large X-large XX-largemm 70 80 85 95 110 120 130 10Length 240 240 240 240 240 240

41、240 MinThickness, mm For All SizesFinger 0.05 MinPalm 0.08 MinCuff 0.05 MinD7198 05 (2012)37.8 Antigenic Protein Content:7.8.1 Determine the extractable antigenic protein (mg/mL)using Test Method D6499 for each glove sample tested.7.8.2 Determine the total microgram of extractable anti-genic protein

42、 in each glove sample by multiplying the resultfrom 7.8.1 by the total volume of extractant used for thatspecific glove sample.7.8.3 Determine the extractable antigenic protein content ofa glove sample by dividing the result from 7.8.2 (totalmicrogram of antigenic protein) by 7.7.3 (total surface ar

43、ea ofglove).7.9 Chemical Permeation:7.9.1 Representative Chemicals to be Tested:7.9.1.1 The following list of embalming chemicals repre-sents the minimum chemicals that shall be tested:Formaldehyde (37 %)Glutaraldehyde (20 %)Phenol (30 %)Methanol (30 %)Bleach (sodium hypochlorite, 5.25 %)7.9.2 The e

44、mbalming chemicals shall be prepared and usedfor permeation testing as routinely used in practice.FIG. 1 Location of Thickness and Length MeasurementsTABLE 5 Physical Requirements for Natural Rubber (Type I)Before Aging After Accelerated AgingTensileStrengthUltimateElongationTensileStrengthUltimateE

45、longation18 MPa min 650 % min 14 MPa min 500 % minTABLE 6 Physical Requirements for Natural Rubber (Type II)Before Aging After Accelerated AgingTensileStrengthUltimateElongationTensileStrengthUltimateElongation14 MPa min 650 % min 14 MPa min 500 % minTABLE 7 Physical Requirements for Synthetic Rubbe

46、r(Polychloroprene)Before Aging After Accelerated AgingTensileStrengthUltimateElongationTensileStrengthUltimateElongation14 MPa min 500 % min 14 MPa min 400 % minTABLE 8 Physical Requirements for Synthetic Rubber (Nitrile)Before Aging After Accelerated AgingTensileStrengthUltimateElongationTensileStr

47、engthUltimateElongation14 MPa min 500 % min 14 MPa min 400 % minTABLE 9 Physical Requirements for Vinyl (PVC)Before Aging After Accelerated AgingTensileStrengthUltimateElongationTensileStrengthUltimateElongation9 MPa min 300 % min 9 MPa min 300 % minD7198 05 (2012)47.9.3 Specific Test Conditions for

48、 Using Test Method F739:7.9.3.1 The test shall be conducted in triplicate at 25 6 2C.7.9.3.2 The outer surface of the glove material shall contactthe donor solution of the test chemical.7.9.3.3 The collection medium shall be mixed continuously.7.9.3.4 Using Test Method F739, the test period shall la

49、stfor 4 h. If breakthrough is achieved before the 4-h end point,the test shall be stopped and the end time recorded. Thefollowing time intervals (at the minimum) shall be used for theanalysis of each glove:5 min15 min30 min45 min60 min120 min180 min240 min7.9.4 Test TerminationThe test shall be continued for thefull 4-h test period and the end time point recorded. This isnecessary to determine the steady-state permeation rate.7.9.4.1 The test may be terminated prior to reaching4hifone of the following occurs:Steady-state permeation is reached.Per