1、Designation: D5250 06 (Reapproved 2015)Standard Specification forPoly(vinyl chloride) Gloves for Medical Application1This standard is issued under the fixed designation D5250; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the yea
2、r 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 poly-(vinyl chloride) gloves used in conducting medical examin
3、a-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 provides for packaged sterile or n
4、onsterile 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 SpecificationD3578 for rubber examination gloves.2. Referenced Documents2.1 ASTM Standards:2D412 Test Me
5、thods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD573 Test Method for RubberDeterioration in an AirOvenD3578 Specification for Rubber Examination GlovesD3767 Practice for RubberMeasurement of DimensionsD5151 Test Method for Detection of Holes in MedicalGlovesD6124 Test Method for Resi
6、dual Powder on Medical Gloves2.2 Other Document:ISO 2859 Sampling Procedures and Tables for Inspection byAttributes3U. S. Pharmacopeia43. Materials3.1 Any poly(vinyl chloride) polymer compound may beused that permits the glove to meet the requirements of thisstandard.3.2 A lubricant that meets the c
7、urrent 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) examination gloves shall be free of talc.4.
8、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 thisstandard.5. Sampling5.1 For referee purposes,
9、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 seller, if thelatter is more comprehensive.6
10、. 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 accordance with 7.3.6.1.3 Have consistent physic
11、al dimensions in accordancewith 7.4.6.1.4 Have acceptable physical property characteristics inaccordance with 7.5.6.1.5 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
12、 tests shall be conducted to ensure therequirements of Section 6, as prescribed in Table 1.1This specification is under the jurisdiction of D11 on Rubber and is the directresponsibility of D11.40 on Consumer Rubber Products.Current edition approved Nov. 1, 2015. Published December 2015. Originallyap
13、proved in 1992. Last previous edition approved in 2011 as D5250 06(2011).DOI: 10.1520/D5250-06R15.2For 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 Docu
14、ment 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.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA
15、19428-2959. United States17.2 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 D5151.7.4 Physical Dimensions Test:7.4.1 The gloves
16、 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 measured at a level between the base
17、 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 micrometerdescribed in Test Methods D412, and in the
18、locations indicatedin Fig. 1. For referee tests, cutting the glove is necessary toobtain single-thickness measurements. (See Practice D3767 formore information.)7.5 Physical Requirements Test:7.5.1 Before and after accelerated aging, the gloves shallconform to the physical requirements specified in
19、Table 3.Tests shall be conducted as specified in Test Methods D412.Die C is recommended.7.5.2 Accelerated aging tests shall be conducted on samplescut from the glove in accordance with Test Method D573 byexposing the glove to 70 6 2C for 72 6 2 h. The glove shallwithstand these conditions without ev
20、idence of tackiness,exudation, or other deterioration.7.6 Powder Free Gloves:7.6.1 Determine the powder residue using Test MethodD6124.7.7 Powdered Gloves:7.7.1 Determine the recommended maximum powder limitusing Test Method D6124 for powdered gloves.7.7.2 Determine the square decimetres for the glo
21、ve size asin 8.7.3 in Specificiation D3578.8. 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 pro-visions of the U.S. Pharmacopeia and ISO
22、 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 sufficientsize when opened to provide a field fo
23、r 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 the sterility of the product until opened ordam
24、aged.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 will be detectable by the user.9.1.7 None of th
25、e 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 and storage.9.2 Nonsterile and Bulk Packagin
26、g:9.2.1 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 strength to withstand normal transportation andstorage within the cartons or shipping cases, or both.TABLE 1 Performance RequirementsC
27、haracteristic Related DefectsInspectionLevelAcceptableQualityLevelsSterility falls sterilityAN/AFreedom from holes holes 2.5Dimensions width, length, andthicknessS-2 4.0Physicalrequirementsbefore aging, afteraccelerated agingS-2 4.0Powder FreeResidueExceeds Maximum Limit N=5 N/APowder Amount Exceeds
28、 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 extralarge, mmsmall medium large x-large 585 95 105 115Length, mm 230 for all sizes minT
29、hickness, mmFinger 0.05 minPalm 0.08 minD5250 06 (2015)29.2.3 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 the product during normaltransportation
30、 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 contents to include the glove size and a
31、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 labeling regulations.ASTM International
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34、ressed 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 known to the ASTM Committee on Standards, at
35、 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
36、(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:/ 1 Location of Thickness MeasurementsTABLE 3 Physical RequirementsTensile Strength, MPa,minUltimate Elongation,% ,min11 300D5250 06 (2015)3
