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

1、Designation: D 7198 05Standard Specification forDisposable Embalming Gloves for Single-Use Applications1This standard is issued under the fixed designation D 7198; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last re

2、vision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) 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 andNitrile), a

3、nd 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 gloves packed in bul

4、k.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: D 3578, D 467

5、9, D 5250, D 6319, and D 6977.1.5 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 user of t

6、his 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:2D 412 Test Methods for Vulcanized Rubber and Thermo-plastic Elastomers-TensionD 573 Test Method for Rubber-Deteriorati

7、on in anAir OvenD 3578 Specification for Rubber Examination GlovesD 3767 Practice for Rubber-Measurement of DimensionsD 4679 Specification for Rubber General Purpose, House-hold or Beautician GlovesD 5151 Test Method for Detection of Holes in MedicalGlovesD 5250 Specification for Poly(vinyl chloride

8、) Gloves forMedical ApplicationD 5712 Test Method for Analysis of Aqueous ExtractableProtein in Natural Rubber and Its Products Using theModified Lowry MethodD 6124 Test Method for Residual Powder on MedicalGlovesD 6319 Specification for Nitrile Examination Gloves forMedical ApplicationD 6499 Test M

9、ethod for the Immunological Measurementof Antigenic Protein in Natural Rubber and its ProductsD 6977 Specification for Polychloroprene ExaminationGloves for Medical ApplicationF 739 Test Method for Resistance of Protective ClothingMaterials to Permeation by Liquids or Gases Under Con-ditions of Cont

10、inuous Contact2.2 ISO Standard:ISO 2859 Sampling Procedures and Tables for Inspectionby Attributes32.3 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 rub

11、ber, and vinyl (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 i

12、ntended to be “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.4. Materials and Manufacture4.1 Any natural rubber, synthetic rubber, and plastic poly-mer compound may be used t

13、hat permits the glove to meet therequirements of this specification.1This specification is under the jurisdiction ofASTM Committee D11 on Rubberand is the direct responsibility of Subcommittee D11.40 on Consumer RubberProducts.Current edition approved Oct. 1, 2005. Published November 2005.2For refer

14、enced 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.3Available from American National Standards Institute (ANSI), 25 W. 43r

15、d St.,4th Floor, New York, NY 10036.4U. S. Pharmacopeia, latest edition, Mack Publishing Co., Easton, PA 19175.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.4.2 A lubricant that meets the current requirements of theU.S. Pharmacopoe

16、ia 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,synthetic rubber, and plastic disposable gloves shall be free oftalc.5. Sampling5.1 For refe

17、ree 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 agreed uponbetween the purchaser and the seller, if the latter is morecomprehensive.6. Perf

18、ormance 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 tested inaccordance with 7.2.6.2.2 Have consistent physical dimensions in accordancewith 7.3.

19、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 A2.1.6.2.5 Powdered gloves shall have a recommended maxi-mum powder limit of 10 mg/dm2in accorda

20、nce 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 with 7.8 and Annex A3.7. Test Methods7.1 The following tests shall be conducted to ensure th

21、erequirements 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 D 5151.7.3 Physical Dimensions Test:7.3.1 The gloves shall comply with the dimension require-ments prescribed in Tables 2-4.7.3.2 The len

22、gth 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 between the base of the index fingerand the base of the thumb. Values of width per size ot

23、her 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 micrometer that meets requirementsdescribed in Test Methods D 412 and Practice D 3767, a

24、nd inthe locations indicated in Fig. 1. For referee tests, cutting theglove is necessary to obtain single-wall thickness measure-ments. (See Practice D 3767 for more information.)7.4 Physical Requirements Test:7.4.1 Before and after accelerated aging, the gloves shallconform to the physical requirem

25、ents specified in Tables 5-9.Tests shall be conducted in accordance with Test MethodsD 412.7.4.2 Accelerated AgingThe gloves shall be aged inaccordance with Test Method D 573. Test the gloves inaccordance with the following methods:7.4.3 After being subjected to a temperature of 70 6 2C for166 6 2 h

26、, 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 62C for 22 6 0.3 h (if validated by manufacturer), the tensilestrength and ultimate el

27、ongation 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 D 6124.7.5.2 The powder residue shall not exceed the recom-mended average powder mass referenced in A2.1 when testedin accordance with T

28、est Method D 6124 for powder-freegloves.7.6 Powdered Gloves:7.6.1 Determine the powder amount for powdered glovesusing Test Method D 6124.7.6.2 The powder amount shall not exceed the recom-mended average powder mass referenced in A2.2 when testedin accordance with Test Method D 6124 for powdered glo

29、ves.7.6.3 Determine the square decimeters for the glove size asdescribed in section 7.7.3 or 7.7.3.1.7.7 Aqueous Extractable Protein Content:7.7.1 Determine the aqueous extractable protein (g/mL)using Test Method D 5712 for each glove sample tested.TABLE 1 Quality Performance and Barrier PropertyReq

30、uirements: Natural Rubber (Latex), Synthetic Rubber(Polychloroprene 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 resid

31、ue exceeds recommendedmaximum limit perAnnex A2.1N=5 N/APowder amount 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-s

32、tate is reachedmaximum rate is reachedpermeation at increased rateN=3 N/AD71980527.7.2 Determine the total g of aqueous extractable proteinin each glove sample by multiplying the result from 7.7.1 bythe total volume of extractable used for that specific glovesample. If the glove sample is less than

33、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 theactual length (mm) and actual width (mm) found on each gloveand convert to dm2using the

34、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 of the glovesmeasured by size.7.7.4 Determine the aqueous extractable protein content of agl

35、ove sample by dividing the result from 7.7.2 (total of g ofProtein) by 7.7.3 (total surface area of the glove.)TABLE 2 Dimensions and Tolerances: Natural Rubber (Latex)NOTESizing that falls within the tolerance overlaps between two sizes may be labeled as a size range including both sizes, for examp

36、le, small/mediumand medium/large.DesignationSizeTolerance,mm6612 7712 8812 9Width by size, mm 75 83 89 95 102 108 114 66Width by label, X-small small Unisize medium large X-large XX-largemm 70 80 85 95 110 120 130 610Length 240 240 240 240 240 240 240 MinThickness, mm For All SizesFinger 0.08 MinPal

37、m 0.08 MinCuff 0.08 MinTABLE 3 Dimensions and Tolerances: Synthetic Rubber (Polychloroprene and Nitrile)NOTESizing that falls within the tolerance overlaps between two sizes may be labeled as a size range including both sizes, for example, small/mediumand medium/large.DesignationSizeTolerance,mm6612

38、 7712 8812 9Width by size, mm 75 83 89 95 102 108 114 66Width by label, X-small small Unisize medium large X-large XX-largemm 70 80 85 95 110 120 130 610Length 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

39、(PVC)NOTESizing that falls within the tolerance overlaps between two sizes may be labeled as a size range including both sizes, for example, small/mediumand medium/large.DesignationSizeTolerance,mm6612 7712 8812 9Width by size, mm 75 83 89 95 102 108 114 66Width by label, X-small small Unisize mediu

40、m large X-large XX-largemm 70 80 85 95 110 120 130 610Length 240 240 240 240 240 240 240 MinThickness, mm For All SizesFinger 0.05 MinPalm 0.08 MinCuff 0.05 MinD71980537.7.5 If the sample is more than one (1) glove, use theaverage g/dm2of protein for the number of gloves tested inthe sample.7.8 Anti

41、genic Protein Content:7.8.1 Determine the extractable antigenic protein (mg/mL)using Test Method D 6499 for each glove sample tested.7.8.2 Determine the total microgram of extractable anti-genic protein in each glove sample by multiplying the resultfrom 7.8.1 by the total volume of extractant used f

42、or 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 area ofglove).7.9 Chemical Permeation:7.9.1 Representative Chemicals to be Tested:7.9.1.1 The follow

43、ing list of embalming chemicals repre-sents the minimum chemicals that shall be tested:Formaldehyde (37 %)Glutaraldehyde (20 %)FIG. 1 Location of Thickness and Length MeasurementsTABLE 5 Physical Requirements for Natural Rubber (Type I)Before Aging After Accelerated AgingTensileStrengthUltimateElong

44、ationTensileStrengthUltimateElongation18 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 Req

45、uirements for Synthetic Rubber(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 AgingTensileStrengt

46、hUltimateElongationTensileStrengthUltimateElongation14 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 % minD7198054Phenol (30 %)

47、Methanol (30 %)Bleach (sodium hypochlorite, 5.25 %)7.9.2 The embalming chemicals shall be prepared and usedfor permeation testing as routinely used in practice.7.9.3 Specific Test Conditions for Using Test Method F 739:7.9.3.1 The test shall be conducted in triplicate at 25 6 2C.7.9.3.2 The outer su

48、rface 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 F 739, the test period shall lastfor 4 h. If breakthrough is achieved before the 4-h end point,the test shall be stopped and the end ti

49、me 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.Permeation proceeds at an ever increasing rate.A maximum rate is reached.7.9.4.2 The breakthrough time shall be deemed to