ASTM D3578-2005 Standard Specification for Rubber Examination Gloves《橡胶检查手套的标准规范》.pdf

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1、Designation: D 3578 05Standard Specification forRubber Examination Gloves1This standard is issued under the fixed designation D 3578; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number in parenthese

2、s indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.This standard has been approved for use by agencies of the Department of Defense.1. Scope1.1 This specification covers certain requirements for natu-ral rubber gloves

3、 used in conducting medical examinations anddiagnostic and therapeutic procedures. It also covers naturalrubber gloves used in handling contaminated medical material.1.2 This specification provides for natural rubber gloves thatfit either hand, paired gloves, and gloves by size. It alsoprovides for

4、packaged sterile natural rubber gloves and pack-aged or bulk nonsterile natural rubber gloves.2. Referenced Documents2.1 ASTM Standards:2D 412 Test Methods for Vulcanized Rubber and Thermo-plastic ElastomersTensionD 573 Test Method for RubberDeterioration in an AirOvenD 3767 Practice for RubberMeasu

5、rement of DimensionsD 5151 Test Method for Detection of Holes in MedicalGlovesD 5712 Test Method for the Analysis of Aqueous Extract-able Protein In Natural Rubber and its Products Using theModified Lowry MethodD 6124 Test Method for Residual Powder on MedicalGlovesD 6499 Test Method for the Immunol

6、ogical Measurementof Antigenic Protein in Natural Rubber and its Products2.2 Other Documents:ISO 2859 Sampling Procedures and Tables for Inspectionby Attributes3U. S. Pharmacopeia43. Classification3.1 Type IGloves with a minimum tensile strength of 18MPa and a maximum stress at 500 % elongation of 5

7、.5 MPa.3.2 Type IIGloves with a minimum tensile strength of 14MPa and a maximum stress at 500 % elongation of 2.8 MPa.4. Materials and Manufacture4.1 Any natural rubber compound that permits the glove tomeet the requirements of this specification.4.2 A lubricant that meets the current requirements o

8、f theU.S. Pharmacopeia 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 rubberexamination gloves shall be free of talc.5. Significance and Use5.1 The s

9、pecification is intended as a reference to theperformance and safety of natural rubber examination gloves.The safe and proper use of natural rubber examination glovesis beyond the scope of this specification.6. Sampling6.1 For referee purposes, gloves shall be sampled andinspected in accordance with

10、 ISO 2859. The inspection levelsand acceptable quality levels (AQL) shall conform to those1This specification is under the jurisdiction ofASTM Committee D11 on Rubberand is the direct responsibility of Subcommittee D11.40 on Consumer RubberProducts.Current edition approved May 1, 2005. Published May

11、 2005. Originallyapproved in 1977. Last previous edition approved in 2001 as D 3578 01ae2.2For 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 Sum

12、mary 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., Easton, PA, 19175.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA

13、19428-2959, United States.specified in Table 1, or as agreed between the purchaser and theseller, if the latter is more comprehensive.7. Performance Requirements7.1 Gloves, sampled in accordance with Section 6, shallmeet the following referee performance requirements:7.1.1 Comply with requirements f

14、or sterility when tested inaccordance with 8.2.7.1.2 Be free from holes when tested in accordance with 8.3.7.1.3 Have consistent physical dimensions in accordancewith 8.4.7.1.4 Have acceptable physical property characteristics inaccordance with 8.5.7.1.5 Have a powder residue limit of 2.0 mg in acco

15、rdancewith 8.6.7.1.6 Have a recommended aqueous soluble protein contentlimit of 200 g/dm2in accordance with 8.7 and Annex A1 orhave a recommended antigenic protein content limit of 10g/dm2in accordance with 8.9 and Annex A2.7.1.7 Have a recommended maximum powder limit of 10mg/dm2in accordance with

16、8.8.8. Referee Test Methods8.1 The following tests shall be conducted to ensure therequirements of Section 8, as prescribed in Table 1:8.2 Sterility TestTesting for sterility shall be conducted inaccordance with the latest edition of The U.S. Pharmacopeia.8.3 Freedom From HolesTesting for freedom fr

17、om holesshall be conducted in accordance with Test Method D 5151.8.4 Physical Dimensions Test (Practice D 3767):8.4.1 The gloves shall comply with the dimension require-ments prescribed in Table 2.8.4.2 The length shall be expressed in millimetres as mea-sured from the tip of the middle finger to th

18、e outside edge ofthe cuff as indicated in Fig. 1.8.4.3 The width of the palm shall be expressed in millime-tres 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 Table 2.8.4.4 T

19、he minimum thickness shall be expressed in milli-metres as specified in Table 2 when using a dial micrometerdescribed in Test Methods D 412 and in the locations indicatedon Fig. 1. For referee tests, cutting the glove is necessary toobtain single-thickness measurements.8.5 Physical Requirements Test

20、:8.5.1 Before and after accelerated aging, the gloves shallconform to the physical requirements specified in Table 3.Tests shall be conducted as specified in Test Methods D 412.8.5.2 Accelerated aging tests shall be conducted in accor-dance with Test Method D 573. Test the gloves by either one ofthe

21、 following methods:8.5.2.1 After being subjected to a temperature of 70 6 2Cfor 166 6 2 h, the tensile strength and ultimate elongation shallnot be less than the values specified in Table 3. This methodshall be the condition for referee tests.8.5.2.2 After being subjected to a temperature of 100 6 2

22、Cfor 22 6 0.3 h, the tensile strength and ultimate elongationshall not be less than the values specified in Table 3.8.6 Powder Free Gloves:8.6.1 Determine the powder residue using Test MethodD 6124.8.7 Aqueous Extractable Protein Content:8.7.1 Determine the aqueous extractable protein (g/mL)using Te

23、st Method D 5712 for each glove sample tested.8.7.2 Determine the total micrograms of aqueous extract-able protein in each glove sample by multiplying the resultfrom 8.7.1 by the total volume of extractant used for thatspecific glove sample. If the glove sample is less than a wholeglove, then adjust

24、 the protein results to reflect the amount ofprotein in the whole glove.8.7.3 Determine the square decimeters for the glove size.Multiply the minimum length and nominal width found inTable 2 and convert to dm2using (dm2/mm2) (mm2/10 000)(4). Four (4) is the factor for all inside and outside surfacea

25、reas.8.7.4 Determine the aqueous extractable protein content of aglove sample by dividing the result from 8.7.2 (total g ofprotein) by 8.7.3 (total surface area of glove).8.7.5 If the sample is more than one (1) glove, use theaverage g/dm2of protein for the number of gloves tested inthe sample.8.8 P

26、owdered Gloves:8.8.1 Determine the recommended maximum powder limitusing Test Method D 6124 for powdered gloves.8.8.2 Determine the square decimeters for the glove size asin 8.7.3.8.9 Antigenic Protein Content:8.9.1 Determine the extractable antigenic protein (g/mL)using Test Method D 6499 for each

27、glove sample tested.8.9.2 Determine the total microgram of extractable anti-genic protein in each glove sample by multiplying the resultfrom 8.9.1 by the total volume of extractant used for thatspecific glove sample.8.9.3 Determine the square decimeter for the glove size as in8.7.3.8.9.4 Determine t

28、he extractable antigenic protein content ofa glove sample by dividing the result from 8.9.2 (totalmicrogram of antigenic protein) by 8.9.3 (total surface area ofglove).TABLE 1 Performance RequirementsCharacteristic Related DefectsInspectionLevelAQLSterility fails sterilityAN/AFreedom from holes hole

29、s I 2.5Dimensions width, length, andthicknessS-2 4.0Physical properties before aging, after accel-erated agingS-2 4.0Powder Free Residue Exceeds Maximum Limit N=5 N/AProtein Content Exceeds RecommendedMaximum LimitN=3 N/APowder Amount Exceeds RecommendedMaximum LimitN=2 N/AAntigenic ProteinContentEx

30、ceeds RecommendedMaximum LimitN=1 N/AASee U.S. Pharmacopeia.D35780529. Acceptance9.1 Gloves will be considered to meet the referee perfor-mance requirements when test results conform to the require-ments prescribed in Table 1.9.2 Retests or reinspections are permissible under the pro-visions of the

31、U.S. Pharmacopeia and ISO 2859.10. Packaging and Marking10.1 Sterile Packaging:10.1.1 The unit of packaging shall normally be one glove orone pair of gloves.10.1.2 Aglove or pair of gloves, normally, shall be enclosedin an inner wallet or wrapper. The wrapper shall be of sufficientsize when opened t

32、o provide a field for glove-donning pur-poses.10.1.3 The glove or pair, and accompanying wrapper ifutilized, shall be totally enclosed in an outer package that shallallow sterilization of the product.10.1.4 The outer package shall have a method of closuresufficient to assure the sterility of the pro

33、duct until opened ordamaged.10.1.5 The outer package shall have sufficient strength andintegrity to withstand normal transportation and storage withinthe intermediate or shipping cartons, or both.10.1.6 The method of closure of the outer package shall besuch that prior opening will be detectable by

34、the user.TABLE 2 Dimensions and TolerancesDesignationSizeTolerance,mm6612 7712 8812 9Width by size, mm 75 83 89 95 102 108 114 66Width by ExtraSmallSmall Unisize Medium Largemm 70 80 85 95 111 610Length, mm 220 220 220 230 230 MinThickness, mm: For All SizesFingerPalm0.080.08MinMinFIG. 1 Location of

35、 Thickness and Length MeasurementsTABLE 3 Physical RequirementsBefore Aging After Accelerated AgingTensileStrengthStress at500 %ElongationUltimateElongationTensileStrengthUltimateElongationType I 18 MPa min 5.5 MPa max 650 % min 14 MPa min 500 % minType II 14 MPa min 2.8 MPa max 650 % min 14 MPa min

36、 500 % minD357805310.1.7 None of the packaging material shall contain anymaterial likely to impair the quality and use of the gloves.10.1.8 Intermediate cartons and shipping cases shall be ofsufficient strength to maintain the quality and sterility of theproduct during normal transportation and stor

37、age.10.2 Nonsterile and Bulk Packaging:10.2.1 The unit of packaging shall normally be more thanone glove and of a specific amount.10.2.2 The gloves shall be enclosed in an outer package thathas sufficient strength to withstand normal transportation andstorage within the cartons or shipping cases, or

38、 both.10.2.3 None of the packaging material shall contain anymaterial likely to impair the quality and use of the gloves.10.2.4 Cartons and shipping cases shall be of sufficientstrength to maintain the quality of the product during normaltransportation and storage.10.3 Marking:10.3.1 Sterile package

39、s shall bear markings for the contentsto include the glove size, instructions for opening, the legend“sterile,” and a manufacturing lot number.10.3.2 Nonsterile and bulk packages shall bear markings forthe contents to include the glove size and a manufacturing lotnumber.10.3.3 The outermost case sha

40、ll be labeled with the glovesize and a manufacturing lot number. Sterile product casesshall also be marked with the legend “sterile.”10.3.4 All levels of packaging shall conform to all appro-priate government labeling regulations.11. Keywords11.1 examination; gloves; rubberANNEXESMandatory Informati

41、onA1. PROTEIN CONTENTA1.1 The current assay precision is large enough that onlya recommended limit can be considered.A1.2 Consideration should be given to the relative repeat-ability and reproducibility when reporting test method results.A1.3 Reasonable allowance should be given for test resultsin e

42、xcess of the recommended limit until greater precision ofthe method can be attained.A2. ANTIGENIC PROTEIN CONTENTA2.1 The current assay precision is large enough that onlya recommended limit can be considered.A2.2 Consideration should be given to the relative repeat-ability and reproducibility when

43、reporting test methods.A2.3 A pooled sample from three individual NR specimensor products as extracted in accordance with Test MethodD 5712 is permitted for use as the extraction sample.APPENDIX(Nonmandatory Information)X1. RationaleX1.1 At a meeting of the Glove Task Force of ASTMD11.40, it was det

44、ermined to expand the physical requirementvalues allowing consumers more choice in fit, feel, and comfortby having two types of examination gloves.D3578054ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard.

45、 Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed e

46、very five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible tec

47、hnical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).D3578055