ASTM D7198-2005(2018) 5000 Standard Specification for Disposable Embalming Gloves for Single-Use Applications.pdf

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1、Designation: D7198 05 (Reapproved 2018)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, health, and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.7 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established

7、 in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermoplas-tic Elastomers

8、TensionD573 Test Method for RubberDeterioration 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 MedicalGlovesD525

9、0 Specification for Poly(vinyl chloride) Gloves forMedical ApplicationD5712 Test Method for Analysis of Aqueous ExtractableProtein in Latex, Natural Rubber, and Elastomeric Prod-ucts Using the Modified Lowry MethodD6124 Test Method for Residual Powder on Medical GlovesD6319 Specification for Nitrile

10、 Examination Gloves forMedical ApplicationD6499 Test Method 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

11、Clothing Materials under Conditions ofContinuous Contact2.2 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

12、of disposable naturalrubber, synthetic rubber, 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.1This specification is under t

13、he jurisdiction ofASTM Committee D11 on Rubberand Rubber-like Materials and is the direct responsibility of Subcommittee D11.40on Consumer Rubber Products.Current edition approved June 1, 2018. Published July 2018. Originally approvedin 2005. Last previous edition approved in 2012 as D7198 05 (2012)

14、. DOI:10.1520/D7198-05R18.2For 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.3Available from American National S

15、tandards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.4U. S. Pharmacopeia, latest edition, Mack Publishing Co., Easton, PA 19175.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was develope

16、d in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.13.3 The chemical perme

17、ation tests described in this speci-fication are intended 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 r

18、ubber, and plastic poly-mer compound may be used that permits the glove to meet therequirements of this 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

19、 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 referee purposes, gloves shall be sampled fromfinished product and inspected in accordance with ISO 2859.The ins

20、pection 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. Performance Requirements6.1 Gloves shall be sampled in accordance with Section 5.6.2 Gloves shall meet the refer

21、ee 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 7.3.6.2.3 Have acceptable physical property characteristics inaccordance with 7.4.6.2.4 Powder-free gloves shall

22、 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 accordance with 7.6 andA2.2.6.2.6 Have a recommended aqueous soluble protein contentlimit of 200 g/dm2in accordance

23、 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 therequirements of Section 8 are met, as prescribed in Table 1.7.2 Freedom from HolesTesting for freedom from

24、holesshall be conducted in accordance with Test Method D5151.7.3 Physical Dimensions Test:7.3.1 The gloves shall comply with the dimension require-ments prescribed in Tables 2-4.7.3.2 The length shall be expressed in millimeters as mea-sured from the outside tip of the middle finger to the outsideed

25、ge 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 other thanlisted shall meet the stated tolerance specified in Tables 2-4.7.3.4 The minimum finger, palm, and cu

26、ff thicknesses shallbe expressed in millimeters as specified in Tables 2-4 whenusing a dial or digital 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

27、thickness measure-ments. (See Practice D3767 for more information.)7.4 Physical Requirements Test:7.4.1 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 Agin

28、gThe gloves shall be aged in ac-cordance with Test Method D573. Test the gloves in accor-dance with the 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

29、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 elongation shall not be less than thevalues specified in Tables 5-9.7.5 Powder Free Gloves:7.5.1 Determine the p

30、owder residue for powder-free glovesusing Test Method D6124.7.5.2 The powder residue shall not exceed the recom-mended average powder mass referenced in A2.1 when testedin accordance with Test Method D6124 for powder-free gloves.7.6 Powdered Gloves:TABLE 1 Quality Performance and Barrier PropertyReq

31、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

32、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

33、tate is reachedmaximum rate is reachedpermeation at increased rateN=3 N/AD7198 05 (2018)27.6.1 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 referenced in A2.2 when testedin accordance with Test Me

34、thod D6124 for powdered gloves.7.6.3 Determine the square decimeters for the glove size asdescribed in section 7.7.3 or 7.7.3.1.7.7 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

35、 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 a whole glove, thenadjust the protein results to reflect the amount of protein in thewhole glove.7.7.3 Det

36、ermine 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 gloveTABLE 2 Dimensions and Tolerances: Natural Rubber (Latex)NOTE 1Sizing that falls within the tolerance overlaps between two sizes may b

37、e 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 small Unisize medium large X-large XX-largemm 70 80 85 95 110 120 130 10Length 240 240 240 240 240 2

38、40 240 MinThickness, mm For All SizesFinger 0.08 MinPalm 0.08 MinCuff 0.08 MinTABLE 3 Dimensions and Tolerances: Synthetic Rubber (Polychloroprene 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,smal

39、l/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 240 240 240 240 240 240 240 MinThickness, mm For All SizesFinger 0.05 MinPalm 0.05 Mi

40、nCuff 0.05 MinTABLE 4 Dimensions and Tolerances: Vinyl (PVC)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

41、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 0.05 MinPalm 0.08 MinCuff 0.05 MinD7198 05 (2018)3and convert to dm2using the following equation: (dm2/mm2)(mm2/10 000)

42、. 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 aglove sample by dividing the result from 7.

43、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 gloves tested inthe sample.7.8 Antigenic Protein Content:7.8.1 Determine the extractable antigenic protein (mg/mL)using Test Method D

44、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 for thatspecific glove sample.FIG. 1 Location of Thickness and Length MeasurementsTABLE 5 Physical R

45、equirements for Natural Rubber (Type I)Before Aging After Accelerated AgingTensileStrengthUltimateElongationTensileStrengthUltimateElongation18 MPa min 650 % min 14 MPa min 500 % minTABLE 6 Physical Requirements for Natural Rubber (Type II)Before Aging After Accelerated AgingTensileStrengthUltimateE

46、longationTensileStrengthUltimateElongation14 MPa min 650 % min 14 MPa min 500 % minTABLE 7 Physical Requirements for Synthetic Rubber(Polychloroprene)Before Aging After Accelerated AgingTensileStrengthUltimateElongationTensileStrengthUltimateElongation14 MPa min 500 % min 14 MPa min 400 % minTABLE 8

47、 Physical Requirements for Synthetic Rubber (Nitrile)Before Aging After Accelerated AgingTensileStrengthUltimateElongationTensileStrengthUltimateElongation14 MPa min 500 % min 14 MPa min 400 % minTABLE 9 Physical Requirements for Vinyl (PVC)Before Aging After Accelerated AgingTensileStrengthUltimate

48、ElongationTensileStrengthUltimateElongation9 MPa min 300 % min 9 MPa min 300 % minD7198 05 (2018)47.8.3 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 Perm

49、eation: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 embalming chemicals shall be prepared and usedfor permeation testing as routinely used in practice.7.9.3 Specific Test Conditions for 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