ASTM D5250-2006e1 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application《医用聚氯乙烯手套的标准规范》.pdf

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1、Designation: D 5250 061Standard Specification forPoly(vinyl chloride) Gloves for Medical Application1This standard is issued under the fixed designation D 5250; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revis

2、ion. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1NOTEEditorially corrected 7.5.1 in December 2008.1. Scope1.1 This specification covers certain requirements for poly-(vinyl chloride) glove

3、s used in conducting medical examina-tions and diagnostic and therapeutic procedures. It also coverspoly(vinyl chloride) gloves used in handling contaminatedmedical material.1.2 This specification provides for poly(vinyl chloride)gloves that fit either hand, paired gloves, and gloves by size. Italso

4、 provides for packaged sterile or nonsterile or bulk non-sterile poly(vinyl chloride) gloves.1.3 This specification does not cover two-dimensional heatsealed poly(vinyl chloride) gloves.1.4 This specification is similar to that of SpecificationD 3578 for rubber examination gloves.2. Referenced Docum

5、ents2.1 ASTM Standards:2D 412 Test Methods for Vulcanized Rubber and Thermo-plastic ElastomersTensionD 573 Test Method for RubberDeterioration in an AirOvenD 3578 Specification for Rubber Examination GlovesD 3767 Practice for RubberMeasurement of DimensionsD 5151 Test Method for Detection of Holes i

6、n MedicalGlovesD 6124 Test Method for Residual Powder on MedicalGloves2.2 Other Document:ISO 2859 Sampling Procedures and Tables for Inspectionby Attributes3U. S. Pharmacopeia43. Materials3.1 Any poly(vinyl chloride) polymer compound may beused that permits the glove to meet the requirements of this

7、standard.3.2 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.3.3 The inside and outside surface of the poly(vinyl chlo-ride) exa

8、mination gloves shall be free of talc.4. Significance and Use4.1 The specification is intended as a referee procedure forevaluating the performance and safety of poly(vinyl chloride)examination gloves. The safe and proper use of poly(vinylchloride) examination gloves is beyond the scope of thisstand

9、ard.5. Sampling5.1 For referee purposes, gloves shall be sampled fromfinished product, after sterilization, and inspected in accor-dance with ISO 2859. The inspection levels and acceptablequality levels (AQL) shall conform to those specified in Table1, or as agreed upon between the purchaser and sel

10、ler, if thelatter is more comprehensive.6. Performance Requirements6.1 Gloves, sampled in accordance with Section 5, shallmeet the following referee performance requirements:6.1.1 Comply with requirements for sterility when tested inaccordance with 7.2.6.1.2 Be free from holes when tested in accorda

11、nce with 7.3.6.1.3 Have consistent physical dimensions in accordancewith 7.4.6.1.4 Have acceptable physical property characteristics inaccordance with 7.5.1This specification is under the jurisdiction of Committee D11 on Rubber and isthe direct responsibility of Subcommittee D11.40 on Consumer Rubbe

12、r Products.Current edition approved Oct. 1, 2006. Published November 2006. Originallyapproved in 1992. Last previous edition approved in 2000 as D 5250 004.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of AST

13、MStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute, 25 W. 43rd St., 4thFloor, New York, NY 10036.4U.S. Pharmacopeia, latest edition, Mack Publishing Co., Easton, PA, 19175.1Copyright ASTM International,

14、 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.6.1.5 Have a powder residue limit of 2.0 mg in accordancewith 7.6.6.1.6 Have a recommended maximum powder limit of 10mg/dm2in accordance with 7.7.7. Referee Test Methods7.1 The following tests shall be conducted to

15、ensure therequirements of Section 6, as prescribed in Table 1.7.2 Sterility TestTesting for sterility shall be conducted inaccordance with the latest edition of The U.S. Pharmacopeia.7.3 Freedom from HolesTesting for freedom from holesshall be conducted in accordance with Test Method D 5151.7.4 Phys

16、ical Dimensions Test:7.4.1 The gloves shall comply with the dimension require-ments prescribed in Table 2.7.4.2 The length shall be expressed in millimetres as mea-sured from the tip of the second finger to the outside edge ofthe cuff.7.4.3 The width of the palm shall be expressed in millime-tres as

17、 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 2.7.4.4 The minimum thickness shall be expressed in milli-metres as specified in Table 2 when using a dial micrometerdescri

18、bed in Test Methods D 412, and in the locations indicatedin Fig. 1. For referee tests, cutting the glove is necessary toobtain single-thickness measurements. (See Practice D 3767for more information.)7.5 Physical Requirements Test:7.5.1 Before and after accelerated aging, the gloves shallconform to

19、the physical requirements specified in Table 3.Tests shall be conducted as specified in Test Methods D 412.Die C is recommended.7.5.2 Accelerated aging tests shall be conducted on samplescut from the glove in accordance with Test Method D 573 byexposing the glove to 70 6 2C for 72 6 2 h. The glove s

20、hallwithstand these conditions without evidence of tackiness,exudation, or other deterioration.7.6 Powder Free Gloves:7.6.1 Determine the powder residue using Test MethodD 6124.7.7 Powdered Gloves:7.7.1 Determine the recommended maximum powder limitusing Test Method D 6124 for powdered gloves.7.7.2

21、Determine the square decimetres for the glove size asin 8.7.3 in Specificiation D 3578.8. Acceptance8.1 Gloves will be considered to meet the referee perfor-mance requirements when test results conform to the require-ments prescribed in Table 1.8.2 Retests or reinspections are permissible under the

22、pro-visions of the U. S. Pharmacopeia and ISO 2859.9. Packaging and Package Marking9.1 Sterile Packaging:9.1.1 The unit of packaging shall normally be one glove orone pair of gloves.9.1.2 A glove or pair of gloves, normally, shall be enclosedin an inner wallet or wrapper. The wrapper shall be of suf

23、ficientsize when opened to provide a field for glove-donning pur-poses.9.1.3 The glove or pair, and accompanying wrapper ifutilized, shall be totally enclosed in an outer package that willallow sterilization of the product.9.1.4 The outer package shall have a method of closuresufficient to ensure th

24、e sterility of the product until opened ordamaged.9.1.5 The outer package shall have sufficient strength andintegrity to withstand normal transportation and storage withinthe intermediate or shipping cartons, or both.9.1.6 The method of closure of the outer package shall besuch that prior opening wi

25、ll be detectable by the user.9.1.7 None of the packaging material shall contain anymaterial likely to impair the quality and use of the gloves.9.1.8 Intermediate cartons and shipping cases shall be ofsufficient strength to maintain the quality and sterility of theproduct during normal transportation

26、 and storage.9.2 Nonsterile and Bulk Packaging:TABLE 1 Performance RequirementsCharacteristic Related DefectsInspectionLevelAcceptableQualityLevelsSterility falls sterilityAN/AFreedom from holes holes I 2.5Dimensions width, length, andthicknessS-2 4.0Physicalrequirementsbefore aging, afteraccelerate

27、d agingS-2 4.0Powder FreeResidueExceeds Maximum Limit N=5 N/APowder Amount Exceeds RecommendedMaximum LimitN=2 N/AASee U.S. Pharmacopeia.TABLE 2 Dimensions and TolerancesDesignationSizeTolerance,mm6 6.5 7 7.5 8 8.5 9Width by size, mm 76 83 89 95 102 108 114 6Width by small, medium, large, and extral

28、arge, mmsmall medium large x-large 585 95 105 115Length, mm 230 for all sizes minThickness, mmFinger 0.05 minPalm 0.08 minD525006129.2.1 The unit of packaging shall normally be more than oneglove and of a specific amount.9.2.2 The gloves shall be enclosed in an outer package thathas sufficient stren

29、gth to withstand normal transportation andstorage within the cartons or shipping cases, or both.9.2.3 None of the packaging material shall contain anymaterial likely to impair the quality and use of the gloves.9.2.4 Cartons and shipping cases shall be of sufficientstrength to maintain the quality of

30、 the product during normaltransportation and storage.9.3 Package Marking:9.3.1 Sterile packages shall bear markings for the contentsto include the glove size, instructions for opening, the legend“sterile,” and a manufacturing lot number.9.3.2 Nonsterile and bulk packages shall bear markings forthe c

31、ontents to include the glove size and a manufacturing lotnumber.9.3.3 The outermost case shall be labeled with the glove sizeand a manufacturing lot number. Sterile product cases shallalso be marked with the legend “sterile.”9.3.4 All levels of packaging shall conform to all appropri-ate government

32、labeling regulations.ASTM International takes no position respecting the validity 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 infringemen

33、t 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 every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or f

34、or additional standardsand should be addressed to ASTM International Headquarters. 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 know

35、n 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).FIG. 1 Location of Thickness MeasurementsTABLE 3 Physical RequirementsTensile Strength, MPa,minUltimate Elongation,% ,min11 300D52500613