ASTM D3577-2009(2015) Standard Specification for Rubber Surgical Gloves《手术用橡胶手套的标准规格》.pdf

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1、Designation: D3577 09 (Reapproved 2015)Standard Specification forRubber Surgical Gloves1This standard is issued under the fixed designation D3577; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number

2、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 pack-

3、aged sterile rubber surgical gloves used in conducting surgicalprocedures.1.2 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.1.3 The following safety hazards caveat pertains only to thetest method portion, Section 8, of this sp

4、ecification: Thisstandard does not purport to address all of the safety concerns,if any, associated with its use. It is the responsibility of the userof this standard to establish appropriate safety and healthpractices and determine the applicability of regulatory limita-tions prior to use.2. Refere

5、nced Documents2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD573 Test Method for RubberDeterioration in an AirOvenD3767 Practice for RubberMeasurement of DimensionsD5151 Test Method for Detection of Holes in MedicalGlovesD5712 Test Method for Analysi

6、s of Aqueous ExtractableProtein in Latex, Natural Rubber, and Elastomeric Prod-ucts Using the Modified Lowry MethodD6124 Test Method for Residual Powder on Medical GlovesD6499 Test Method for The Immunological Measurement ofAntigenic Protein in Natural Rubber and its Products2.2 Other Documents:ISO

7、2859 Sampling Procedures and Tables for Inspection byAttributes3U.S. Pharmacopeia43. Classification3.1 Type 1Gloves compounded primarily from naturalrubber latex.3.2 Type 2Gloves compounded from a rubber cement orfrom synthetic rubber latex.4. Materials and Manufacture4.1 Any rubber polymer compound

8、 that permits the glove tomeet the requirements of this specification.4.2 A lubricant that meets 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 Th

9、e inside and outside surface of the rubber surgicalgloves shall be free of talc.5. Significance and Use5.1 The specification is intended as a reference to theperformance and safety of rubber surgical gloves. The safe andproper use of rubber surgical gloves is beyond the scope of thisspecification.6.

10、 Sampling6.1 For referee purposes, gloves shall be sampled andinspected 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. Performan

11、ce Requirements7.1 Gloves, sampled in accordance with Section 6, shallmeet the following referee performance requirements:1This specification is under the jurisdiction ofASTM Committee D11 on Rubberand is the direct responsibility of Subcommittee D11.40 on Consumer RubberProducts.Current edition app

12、roved Nov. 1, 2015. Published December 2015. Originallyapproved in 1977. Last previous edition approved in 2009 as D3577 091. DOI:10.1520/D3577-09R15.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStand

13、ards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute, 25 West 43rd St., 4thFloor, New York, NY 10036.4U.S. Pharmacopeia, latest edition, Mack Publishing Co., Easton, PA 19175.Copyright ASTM International, 100 B

14、arr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States17.1.1 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 accepta

15、ble physical property characteristics inaccordance with 8.5.7.1.5 Have a powder residue limit of 2.0 mg in accordancewith 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/dm2i

16、n accordance with 8.9 and Annex A2.7.1.7 Have a recommended maximum powder limit of 15mg/dm2in accordance with 8.8.8. Referee Test Methods8.1 The following tests shall be conducted to assure therequirements of Section 7 as prescribed in Table 1:8.2 Sterility Test Testing for sterility shall be condu

17、cted inaccordance with the latest edition of the U.S. Pharmacopeia.8.3 Freedom from HolesTesting for freedom from holesshall be conducted in accordance with Test Method D5151.8.4 Physical Dimensions Test:8.4.1 The gloves shall comply with the dimension require-ments specified in Table 2.8.4.2 The le

18、ngth shall be expressed in millimetres as mea-sured from the tip of the second finger to the outside edge ofthe cuff.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 tha

19、nlisted shall 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 Practice D3767 and in the locations indicated onFig. 1. For referee tests, cutting the glove is necessary to ob

20、tainsingle-thickness measurements.8.4.5 Precision and BiasThe precision and bias of mea-suring glove dimensions are as specified in Practice D3767.8.5 Physical Requirements Test:8.5.1 Before and after accelerated aging, the gloves shallconform to the physical requirements specified in Table 3.Tests

21、shall be conducted in accordance with Test MethodsD412. Die C is recommended.8.5.2 Accelerated aging tests shall be conducted 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 tensil

22、e 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 2Cfor 22 6 0.3 h, the tensile strength and ultimate elongationshall not be less than the values specif

23、ied in Table 3.8.5.3 Precision and BiasThe precision and bias of deter-mining tensile strength and ultimate elongation of gloves are asspecified in Test Methods D412.8.6 Powder Free Gloves:8.6.1 Determine the powder residue using Test MethodD6124.8.7 Aqueous Extractable Protein Content:8.7.1 Determi

24、ne the aqueous extractable protein (g/mL)using Test Method D5712 for each glove sample tested.8.7.2 Determine the total g of aqueous extractable proteinin each glove sample by multiplying the result from 8.7.1 bythe total volume of extractant used for that specific glovesample. If the glove sample i

25、s less than a whole glove, thenadjust the protein results to reflect the amount of protein in thewhole glove.8.7.3 Determine the square decimetres for the glove size.Multiply the minimum length and nominal width found inTable 2 and convert to dm2using (dm2/mm2) (mm2/10 000).Four (4) is the factor fo

26、r all inside and outside surface areas.TABLE 1 Performance RequirementsCharacteristic Related DefectsInspectionLevelAQLSterility fails sterilityAN/AFreedom from holes holes 1.5Physical dimensions length, width, andthicknessS-2 4.0Physical properties before aging, after accel-erated agingS-2 4.0Powde

27、r 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 and TolerancesDesignationSizeTolerance512 6

28、612 7712 8812 9Length, mm 245 265 265 265 265 265 265 265 minWidth, mm 70 76 83 89 95 102 108 114 6Thickness, mm:Finger 0.10 minPalm 0.10 minCuff 0.10 minD3577 09 (2015)28.7.4 Determine the aqueous extractable protein content of aglove sample by dividing the result from 8.7.2 (total g ofprotein) by

29、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 Powdered Gloves:8.8.1 Determine the recommended maximum powder limitusing Test Method D6124 for powdered gloves.8.8.2 Determine the squa

30、re 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 D6499 for each glove sample tested.8.9.2 Determine the total microgram of extractable anti-genic protein in each glove sample by multiplying the resultf

31、rom 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 sample by dividing the result from 8.9.2 (totalmicrogram of antigenic protein) by 8.9.

32、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 are permissible under the pro-visions of the U.S. Pharmacopeia and ISO 2859.10. Pa

33、ckaging and Package Marking10.1 PackagingPackaging shall be provided to maintainsterility after sterilization during shipping and storage andpermit opening without contamination of the gloves.FIG. 1 Location of Thickness MeasurementsTABLE 3 Physical RequirementsTypeBefore Aging After Accelerated Agi

34、ngTensileStrengthUltimateElongationStress at 500 %ElongationTensileStrengthUltimateElongationI 24 MPa, min 750 % min 5.5 MPa, max 18 MPa, min 560 % minII 17 MPa, min 650 % min 7.0 MPa, max 12 MPa, min 490 % minD3577 09 (2015)310.2 Marking:10.2.1 Gloves shall have an appropriate marking or becolor-co

35、ded to designate size.10.2.2 Inner wrappers or wallets, if used, shall bear a sizemarking to be located on the outside of the wallet or wrapper.10.2.3 Packages shall bear markings for the contents toinclude the glove size, instructions for opening, the legend“sterile,” and a manufacturing lot number

36、.10.2.4 The outermost case shall be labeled on one or moreend panels with the glove size, the legend “sterile,” and amanufacturing lot number.10.2.5 All levels of packaging shall conform to all appro-priate government labeling regulations.11. Keywords11.1 gloves; rubber; surgicalANNEXES(Mandatory In

37、formation)A1. 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 test method results.A1.3 Reasonable allowance should be given for test res

38、ultsin 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 only arecommended limit can be considered.A2.2 Consideration should be given to the relative repeat-ability and reproducibili

39、ty when reporting test method results.A2.3 A pooled sample from three individual NR specimensor products as extracted in Test Method D5712 is permitted foruse as the extraction sample.ASTM International takes no position respecting the validity of any patent rights asserted in connection with any it

40、em 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 subject to revision at any time by the responsible technical com

41、mittee 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 Headquarters. Your comments will receive careful consideration at a

42、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 is copyrighted by ASTM International, 100 Barr Harbor Driv

43、e, 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:/ 09 (2015)4