ASTM D3578-2005(2015) Standard Specification for Rubber Examination Gloves《检查用橡胶手套的标准规格》.pdf

1、Designation: D3578 05 (Reapproved 2015)Standard Specification forRubber Examination Gloves1This standard is issued under the fixed designation D3578; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A numb

2、er in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.This standard has been approved for use by agencies of the U.S. Department of Defense.1. Scope1.1 This specification covers certain requirements for na

3、tu-ral rubber gloves 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.

4、It alsoprovides for packaged sterile natural rubber gloves and pack-aged or bulk nonsterile natural rubber gloves.2. Referenced Documents2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD573 Test Method for RubberDeterioration in an AirOvenD3767 Practic

5、e for RubberMeasurement of DimensionsD5151 Test Method for Detection of Holes in MedicalGlovesD5712 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 GlovesD6499 T

6、est Method for The Immunological Measurement ofAntigenic Protein in Natural Rubber and its Products2.2 Other Documents:ISO 2859 Sampling Procedures and Tables for Inspection byAttributes3U. S. Pharmacopeia43. Classification3.1 Type IGloves with a minimum tensile strength of 18MPa and a maximum stres

7、s at 500 % elongation of 5.5 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

8、the current requirements of 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. Sig

9、nificance and Use5.1 The specification 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 andin

10、spected in accordance with ISO 2859. The inspection levelsand acceptable quality levels (AQL) shall conform to thosespecified 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,

11、 shallmeet the following referee performance requirements:7.1.1 Comply with requirements for 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

12、 characteristics inaccordance with 8.5.7.1.5 Have a powder residue limit of 2.0 mg in accordancewith 8.6.1This specification is under the jurisdiction ofASTM Committee D11 on Rubberand is the direct responsibility of Subcommittee D11.40 on Consumer RubberProducts.Current edition approved Nov. 1, 201

13、5. Published December 2015. Originallyapproved in 1977. Last previous edition approved in 2010 as D3578 05(2010).DOI: 10.1520/D3578-05R15.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume

14、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., Easton, PA, 19175.Copyright ASTM International, 100 Barr Ha

15、rbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States17.1.6 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 recom

16、mended maximum powder limit of 10mg/dm2in accordance with 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.

17、 Pharmacopeia.8.3 Freedom From HolesTesting for freedom from holesshall be conducted in accordance with Test Method D5151.8.4 Physical Dimensions Test (Practice D3767):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 millimet

18、res as mea-sured from the tip of the middle finger to the 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 shal

19、l meet the stated tolerance specified in Table 2.8.4.4 The minimum thickness shall be expressed in milli-metres as specified in Table 2 when using a dial micrometerdescribed in Test Methods D412 and in the locations indicatedon Fig. 1. For referee tests, cutting the glove is necessary toobtain singl

20、e-thickness measurements.8.5 Physical Requirements Test: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 D412.Die C is recommended.8.5.2 Accelerated aging tests shall be conducted

21、 in accor-dance with Test Method D573. Test the gloves by either one ofthe 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 f

22、or referee tests.8.5.2.2 After being subjected to a temperature of 100 6 2Cfor 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 MethodD6124.8.7 Aqueous Extractable Prote

23、in Content:8.7.1 Determine the aqueous extractable protein (g/mL)using Test Method D5712 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

24、glove sample. If the glove sample is less than a wholeglove, then adjust 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) (mm

25、2/10 000)(4). Four (4) is the factor for all inside and outside surfaceareas.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 theav

26、erage g/dm2of protein for the number of gloves tested inthe sample.8.8 Powdered Glove:8.8.1 Determine the recommended maximum powder limitusing Test Method D6124 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

27、extractable antigenic protein (g/mL)using Test Method D6499 for each glove sample tested.TABLE 1 Performance RequirementsCharacteristic Related DefectsInspectionLevelAQLSterility fails sterilityAN/AFreedom from holes holes 2.5Dimensions width, length, andthicknessS-2 4.0Physical properties before ag

28、ing, 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 ProteinContentExceeds RecommendedMaximum LimitN=1 N/AASee U.S. Pharmacopeia.TABLE 2 Dimensions an

29、d TolerancesDesignationSizeTolerance,mm6612 7712 8812 9Width by size, mm 75 83 89 95 102 108 114 6Width by ExtraSmallSmall Unisize Medium Largemm 70 80 85 95 111 10Length, mm 220 220 220 230 230 MinThickness, mm: For All SizesFingerPalm0.080.08MinMinD3578 05 (2015)28.9.2 Determine the total microgra

30、m 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 the extractable antigenic protein content ofa glove sam

31、ple by dividing the result from 8.9.2 (totalmicrogram of antigenic protein) by 8.9.3 (total surface area ofglove).9. 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

32、 are permissible under the pro-visions of the 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 wr

33、apper shall be of sufficientsize when opened to 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 closur

34、esufficient to assure the sterility of the product 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 be

35、such that prior opening will be detectable by the user.10.1.7 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

36、during normal transportation and storage.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 wit

37、hin the cartons or shipping cases, or both.FIG. 1 Location of 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

38、 500 % minType II 14 MPa min 2.8 MPa max 650 % min 14 MPa min 500 % minD3578 05 (2015)310.2.3 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 pr

39、oduct during normaltransportation and storage.10.3 Marking:10.3.1 Sterile packages 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 i

40、nclude the glove size and a manufacturing lotnumber.10.3.3 The outermost case shall 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 r

41、egulations.11. Keywords11.1 examination; gloves; rubberANNEXESMandatory InformationA1. PROTEIN CONTENTA1.1 The current assay precision is large enough that only arecommended limit can be considered.A1.2 Consideration should be given to the relative repeat-ability and reproducibility when reporting t

42、est method results.A1.3 Reasonable allowance should be given for test resultsin excess 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 Consi

43、deration should be given to the relative repeat-ability and reproducibility when reporting test methods.A2.3 A pooled sample from three individual NR specimensor products as extracted in accordance with Test MethodD5712 is permitted for use as the extraction sample.APPENDIX(Nonmandatory Information)

44、X1. RationaleX1.1 At a meeting of the Glove Task Force of ASTMD11.40, it was determined to expand the physical requirementvalues allowing consumers more choice in fit, feel, and comfortby having two types of examination gloves.D3578 05 (2015)4ASTM International takes no position respecting the valid

45、ity of any patent rights asserted in connection with any item mentionedin this standard. 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 subje

46、ct to revision at any time by the responsible technical committee and must be reviewed every 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 Headquart

47、ers. Your comments will receive careful consideration at a meeting of theresponsible technical 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

48、 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). Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 05 (2015)5