ASTM D7103-2006e1 1250 Standard Guide for Assessment of Medical Gloves《医用手套评估的标准指南》.pdf

1、Designation: D7103 061Standard Guide forAssessment of Medical Gloves1This standard is issued under the fixed designation D7103; 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 parentheses indi

2、cates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1NOTEEditorially corrected 8.3 in April 2010.1. Scope1.1 This guide is intended to assist in the identification andapplication of the most appropriate ASTM and associatedsta

3、ndards for the assessment, development of specifications,and selection of medical gloves with the ultimate goal ofmaintaining the safety and health of healthcare workers whomay come into contact with biological and chemical hazards.1.2 No guidance document or assessment protocol canensure the select

4、ion of medical gloves that guarantees health-care worker protection. The purpose of testing and assessingmedical gloves is to generate the performance data and qualityinformation that will allow the most appropriate assessmentand selection of medical gloves. Ultimately, the selection ofmedical glove

5、s shall be based on the evaluation of availabletechnical data, quality information, and professional assess-ment of risk.1.3 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-p

6、riate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermo-plastic ElastomersTensionD573 Test Method for RubberDeterioration in an AirOvenD3577 Specification f

7、or Rubber Surgical GlovesD3578 Specification for Rubber Examination GlovesD3767 Practice for RubberMeasurement of DimensionsD5151 Test Method for Detection of Holes in MedicalGlovesD5250 Specification for Poly(vinyl chloride) Gloves forMedical ApplicationD5712 Test Method for Analysis of Aqueous Ext

8、ractableProtein in Natural Rubber and Its Products Using theModified Lowry MethodD6124 Test Method for Residual Powder on MedicalGlovesD6319 Specification for Nitrile Examination Gloves forMedical ApplicationD6499 Test Method for The Immunological Measurementof Antigenic Protein in Natural Rubber an

9、d its ProductsD6977 Specification for Polychloroprene ExaminationGloves for Medical ApplicationF739 Test Method for Permeation of Liquids and Gasesthrough Protective Clothing Materials under Conditions ofContinuous ContactF1342 Test Method for Protective Clothing Material Resis-tance to PunctureF138

10、3 Test Method for Permeation of Liquids and Gasesthrough Protective Clothing Materials under Conditions ofIntermittent ContactF1671 Test Method for Resistance of Materials Used inProtective Clothing to Penetration by Blood-Borne Patho-gens Using Phi-X174 Bacteriophage Penetration as a TestSystem2.2

11、American National Standards Institute/American Den-tal Association (ANSI/ADA) Standards:Acceptance Program Guidelines Infection Control Prod-ucts3Specification No. 76 Non-Sterile Natural Rubber LatexGloves for Dentistry3Specification No. 102 Non-Sterile Nitrile Gloves for Den-tistry3Specification No

12、. 103 Non-Sterile Poly(vinyl chloride)Gloves for Dentistry32.3 International Standards Organization (ISO) Standard:ISO 2859 Sampling Procedures and Tables for Inspectionby Attributes32.4 National Fire Protection Association (NFPA) Standard:NFPA 1999 Standard on Protective Clothing for Emergency1This

13、 guide is under the jurisdiction of ASTM Committee D11 on Rubber andis the direct responsibility of Subcommittee D11.40 on Consumer Rubber Products.Current edition approved Feb. 15, 2006. Published March 2006. DOI: 10.1520/D7103-06E01.2For referenced ASTM standards, visit the ASTM website, www.astm.

14、org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume 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 10036.1Copyright ASTM Int

15、ernational, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.Medical Operations43. Terminology3.1 Definitions:3.1.1 medical glovessurgeons (surgical) and patient ex-amination (examination) gloves for use in medical applica-tions. Medical gloves are medical devices

16、that are regulated byThe Food and Drug Administration (FDA).3.1.2 natural rubber latex (NRL) glovesgloves manufac-tured from natural rubber latex (latex).3.1.3 syntheic plastic glovesgloves manufactured from asynthetic plastic material such as poly(vinyl chloride).3.1.3.1 DiscussionThe actual name o

17、f the plastic materialmust be stated on the packaging.3.1.4 synthetic rubber glovesgloves manufactured from asynthetic rubber material, such as (1) polychloroprene and (2)acrylonitrile butadiene (nitrile).3.1.4.1 DiscussionThe actual name of synthetic rubbermust be stated on the packaging.4. Signifi

18、cance and Use4.1 The standards under the jurisdiction of CommitteeD11.40 and other technical committees can be used individu-ally or as part of an integrated protocol in the assessment andselection of medical gloves.4.2 The intended use of the standards is as a means bywhich information can be reque

19、sted, generated, and reported ina consistent, comparable manner.4.3 The suggested assessments and test methods are recom-mended guidelines.4.4 Test methods offer procedures for assessing medicalgloves at standardized conditions to allow comparison.4.5 The information on medical glove performance mus

20、t becombined with professional judgment, and a clear understand-ing of the application, in order for the medical glove to providethe best performance.4.6 Medical gloves intended for use during emergencymedical operations may be evaluated and their performancecertified to NFPA 1999, Standard on Prote

21、ctive Clothing forEmergency Medical Operations. This certification program isvoluntary.5. Assessment of the Quality5.1 Each of the following medical glove standards providesminimum quality specifications for the medical glove that itdescribes: Specifications D3577, D3578, D5250, D6319, andD6977.5.2

22、Each medical glove standard listed in 5.1 also providesmaterial-specific performance specifications.5.3 Each of the medical glove standards listed in 5.1contains minimum quality standards, which include an as-signed inspection level and AQL (acceptable quality level) perISO 2859 for each of the foll

23、owing:5.3.1 Holes:5.3.1.1 Test Method D5151 describes how to detect holes inmedical gloves.5.3.1.2 Each medical glove standard listed in 5.1 has as-signed a minimum inspection level and an associated minimumAQL to be used when assessing medical gloves for holes.5.3.2 Dimensions:5.3.2.1 Practice D376

24、7 describes how to properly determinethe geometrical dimensions of rubber products for physicaltests.5.3.2.2 Each medical glove standard listed in 5.1 providesmaterial specific specifications for palm width, length, andthickness.5.3.3 Physical PropertiesThe primary physical propertiesfor medical glo

25、ves include tensile strength and ultimate elon-gation.NOTE 1Medical gloves manufactured from natural rubber latex alsoinclude a before-accelerated-aging test that measures the stress at 500 %elongation.5.3.3.1 This test measure is determined by measuring thestress at 500 % elongation in accordance w

26、ith Test MethodsD412.5.3.3.2 Medical gloves are tested for physical propertiesbefore and after accelerated aging.5.3.3.3 Before accelerated aging tests are performed inaccordance with Test Methods D412.5.3.3.4 After accelerated aging tests are performed in accor-dance with Test Method D573.6. Assess

27、ment of Powder Residue on Powder-freeMedical Gloves6.1 The powder residue on powder-free medical glovesshall be measured in accordance with Test Method D6124.6.2 The recommended powder residue limit for powder-freemedical gloves is not more than 2 mg per glove.7. Assessment of the Amount of Powder o

28、n PowderedMedical Gloves7.1 The amount of powder on powdered medical glovesshall be measured in accordance with Test Method D6124.7.2 The recommended powder amount limit for powderedexamination gloves is not more than 10 mg/dm2.7.2.1 Aunit of measure used to denote surface area is dm2=square decimet

29、re.7.3 The recommended powder amount limit for powderedsurgical gloves is not more than 15 mg/dm2.7.3.1 Aunit of measure used to denote surface area is dm2=square decimetre.8. Assessment of Extractable Protein for Natural RubberLatex Medical Gloves8.1 In accordance with Specification D3578, the cont

30、ent ofaqueous soluble protein in natural rubber latex medical glovesshall be determined using Test Method D5712.NOTE 2The FDA requires that Test Method D5712 be performed insupport of a 510(k) Premarket Notification submission.8.2 The recommended aqueous soluble protein content limitfor natural rubb

31、er latex medical gloves is not more than 200g/dm2.4Available from National Fire Protection Association (NFPA), 1 BatterymarchPark, Quincy, MA 02269-9101.D7103 06128.2.1 This recommended aqueous soluble protein contentlimit is in accordance with the performance requirements setforth in the performanc

32、e requirements section of SpecificationD3578.8.3 The FDA regulates extractable protein content labelclaims. The lowest protein content label allowed by the FDAis50 g/dm2of glove.9. Assessment of Antigenic Protein for Natural RubberLatex Medical Gloves9.1 In accordance with Specification D3578, the a

33、mount ofextractable antigenic protein in natural rubber latex medicalgloves shall be determined using Test Method D6499.9.2 The recommended antigenic protein content limit fornatural rubber latex medical gloves is not more than 10 g/dm2per Test Method D6499.9.2.1 This recommended antigenic protein c

34、ontent limit isin accordance with the performance requirements set forth inthe performance requirements section of Specification D3578.10. Assessment of Resistance to Viral Penetration10.1 Medical gloves may be evaluated for resistance to viralpenetration in accordance with Test Method F1671.10.1.1

35、Test Method F1671 measures the resistance of ma-terials to penetration by blood-borne pathogens using a surro-gate microbe under conditions of continuous liquid contact.10.1.1.1 Test material pass/fail determinations are based onthe detection of viral penetration.10.1.1.2 This test method has been s

36、pecifically defined formodeling the viral penetration of Hepatitis (B and C) andHuman Immunodeficiency Viruses transmitted in blood andother potentially infectious body fluids.10.1.2 This test system does not allow for a whole glove tobe tested; however, a representative specimen of the medicalglove

37、 material may be tested.11. Assessment of Chemical Resistance11.1 The two most commonly used chemical resistance testmethods to measure the chemical resistance of medical glovesare continuous contact (Test Method F739) and intermittentcontact (Test Method F1383).11.1.1 Test Method F739:11.1.1.1 This

38、 test method measures breakthrough detectiontime, normalized breakthrough detection time, and subsequentpermeation rate through replicate specimens of the test materialto assess the resistance of a test material to permeation by a testchemical.11.1.1.2 Test Method F739 allows several configurations

39、ofthe test, including the choice of collection media, detectionsystems, the test temperature, and length of the test.11.1.2 Test Method F1383:11.1.2.1 This test method is a variation of Test Method F739and is used to measure breakthrough detection time andpermeation rate through material specimens u

40、nder the condi-tions of intermittent contact of the test chemical with thematerial specimen.11.1.2.2 Test Method F1383 is designed to simulate the typeof chemical exposures where chemical contact occurs throughperiodic exposure through repeated splashes depending on thetype of task in which the heal

41、thcare worker is involved.12. Assessment of Puncture Resistance12.1 The puncture resistance of elastomeric materials suchas those used to manufacture medical gloves can be testedusing Test Method F1342.12.1.1 Test Method F1342 measures the puncture resistanceof a material specimen by measuring the f

42、orce required tocause a specifically defined puncture probe to penetratethrough the material specimen.NOTE 3Test Method F1342 is not designed to detect resistance topuncture by sharps, such as needles.13. Assessment of Examination Gloves for EmergencyMedical Services (EMS) per NFPA13.1 The NFPA 1999

43、 standard allows for examinationgloves to be certified to its listed quality and performancecriteria via the use of an independent, third party certificationorganization that is approved by NFPA.13.1.1 The certification organization determines whether ornot the product is compliant with the requirem

44、ents inNFPA 1999 and includes a labeling/listing/follow-up program.14. Assessment of Medical Gloves per ANSI/ADA14.1 The ADA also lists specification standards for medicalgloves: ANSI/ADA Specification No. 76, ANSI/ADA Specifi-cation No. 102, and ANSI/ADA Specification No. 103.15. Selection of Medic

45、al Gloves15.1 There is no one single type of medical glove that willmeet the needs of every application.15.2 The selection of medical gloves shall be based on theevaluation of available technical data, quality information,overall medical glove design, and the professional assessmentof risk.16. Keywo

46、rds16.1 assessment; barrier properties; latex; medical gloves;natural rubber latex; nitrile; performance; physical properties;polychloroprene; quality; selection; vinylD7103 0613ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item men

47、tionedin 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 committee

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49、g 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 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