ASTM D7103-2006(2013) 0625 Standard Guide for Assessment of Medical Gloves《医用手套评定的标准指南》.pdf

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1、Designation: D7103 06 (Reapproved 2013)Standard 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

2、 parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide is intended to assist in the identification andapplication of the most appropriate ASTM and associatedstandards for the assessment, d

3、evelopment 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 selection of medical gloves that g

4、uarantees 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 gloves shall be based on the eval

5、uation 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-priate safety and health prac

6、tices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD573 Test Method for RubberDeterioration in an AirOvenD3577 Specification for Rubber Surgical GlovesD35

7、78 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 ExtractableProtein in Natural R

8、ubber and Its Products Using theModified Lowry MethodD6124 Test Method for Residual Powder on Medical GlovesD6319 Specification for Nitrile Examination Gloves forMedical ApplicationD6499 Test Method for The Immunological Measurement ofAntigenic Protein in Natural Rubber and its ProductsD6977 Specifi

9、cation 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 PunctureF1383 Test Method for Permeatio

10、n 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 American National Standards

11、 Institute/American DentalAssociation (ANSI/ADA) Standards:Acceptance Program Guidelines Infection Control Products3Specification No. 76 Non-Sterile Natural Rubber LatexGloves for Dentistry3Specification No. 102 Non-Sterile Nitrile Gloves for Den-tistry3Specification No. 103 Non-Sterile Poly(vinyl c

12、hloride)Gloves for Dentistry32.3 International Standards Organization (ISO) Standard:ISO 2859 Sampling Procedures and Tables for Inspection byAttributes32.4 National Fire Protection Association (NFPA) Standard:NFPA 1999 Standard on Protective Clothing for EmergencyMedical Operations41This guide is u

13、nder the jurisdiction of ASTM Committee D11 on Rubber andis the direct responsibility of Subcommittee D11.40 on Consumer Rubber Products.Current edition approved May 1, 2013. Published May 2013. Originallyapproved in 2006. Last previous edition approved in 2006 as D7103 061. DOI:10.1520/D7103-06R13.

14、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 Document Summary page onthe ASTM website.3Available from American National Standards Institute (ANSI),

15、 25 W. 43rd St.,4th Floor, New York, NY 10036.4Available from National Fire Protection Association (NFPA), 1 BatterymarchPark, Quincy, MA 02269-9101.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States13. Terminology3.1 Definitions:3.1.1 m

16、edical glovessurgeons (surgical) and patient ex-amination (examination) gloves for use in medical applica-tions. Medical gloves are medical devices that are regulated byThe Food and Drug Administration (FDA).3.1.2 natural rubber latex (NRL) glovesgloves manufac-tured from natural rubber latex (latex

17、).3.1.3 syntheic plastic glovesgloves manufactured from asynthetic plastic material such as poly(vinyl chloride).3.1.3.1 DiscussionThe actual name of the plastic materialmust be stated on the packaging.3.1.4 synthetic rubber glovesgloves manufactured from asynthetic rubber material, such as (1) poly

18、chloroprene and (2)acrylonitrile butadiene (nitrile).3.1.4.1 DiscussionThe actual name of synthetic rubbermust be stated on the packaging.4. Significance 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 integ

19、rated protocol in the assessment andselection of medical gloves.4.2 The intended use of the standards is as a means bywhich information can be requested, generated, and reported ina consistent, comparable manner.4.3 The suggested assessments and test methods are recom-mended guidelines.4.4 Test meth

20、ods offer procedures for assessing medicalgloves at standardized conditions to allow comparison.4.5 The information on medical glove performance must becombined with professional judgment, and a clear understand-ing of the application, in order for the medical glove to providethe best performance.4.

21、6 Medical gloves intended for use during emergencymedical operations may be evaluated and their performancecertified to NFPA 1999, Standard on Protective Clothing forEmergency Medical Operations. This certification program isvoluntary.5. Assessment of the Quality5.1 Each of the following medical glo

22、ve standards providesminimum quality specifications for the medical glove that itdescribes: Specifications D3577, D3578, D5250, D6319, andD6977.5.2 Each medical glove standard listed in 5.1 also providesmaterial-specific performance specifications.5.3 Each of the medical glove standards listed in 5.

23、1contains minimum quality standards, which include an as-signed inspection level and AQL (acceptable quality level) perISO 2859 for each of the following: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-sign

24、ed 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 D3767 describes how to properly determinethe geometrical dimensions of rubber products for physicaltests.5.3.2.2 Each medical glove standard listed in 5.1 p

25、rovidesmaterial specific specifications for palm width, length, andthickness.5.3.3 Physical PropertiesThe primary physical propertiesfor medical gloves include tensile strength and ultimate elon-gation.NOTE 1Medical gloves manufactured from natural rubber latex alsoinclude a before-accelerated-aging

26、 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 with 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

27、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. Assessment of Powder Residue on Powder-freeMedical Gloves6.1 The powder residue on powder-free medical glovesshall be measured in accordance with Test Method

28、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 on PowderedMedical Gloves7.1 The amount of powder on powdered medical glovesshall be measured in accordance with Test Method D6124.7.2 The recommended po

29、wder 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 decimetre.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

30、dm2=square decimetre.8. Assessment of Extractable Protein for Natural RubberLatex Medical Gloves8.1 In accordance with Specification D3578, the content ofaqueous soluble protein in natural rubber latex medical glovesshall be determined using Test Method D5712.NOTE 2The FDA requires that Test Method

31、D5712 be performed insupport of a 510(k) Premarket Notification submission.8.2 The recommended aqueous soluble protein content limitfor natural rubber latex medical gloves is not more than 200g/dm2.D7103 06 (2013)28.2.1 This recommended aqueous soluble protein contentlimit is in accordance with the

32、performance requirements setforth in the performance 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 Glov

33、es9.1 In accordance with Specification D3578, the amount 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 Meth

34、od D6499.9.2.1 This recommended antigenic protein content 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 viralpenet

35、ration in accordance with Test Method F1671.10.1.1 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 vir

36、al penetration.10.1.1.2 This test method has been specifically 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; how

37、ever, a representative specimen of the medicalglove 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

38、Method F1383).11.1.1 Test Method F739:11.1.1.1 This 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.

39、1.2 Test Method F739 allows several configurations 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 t

40、ime andpermeation rate through material specimens under 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 spla

41、shes depending on thetype of task in which the healthcare 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

42、resistanceof a material specimen by measuring the force 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 Emergen

43、cyMedical Services (EMS) per NFPA13.1 The NFPA 1999 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 wheth

44、er ornot the product is compliant with the requirements in NFPA1999 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 AN

45、SI/ADA Specification No. 103.15. Selection of Medical 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 desig

46、n, and the professional assessmentof risk.16. Keywords16.1 assessment; barrier properties; latex; medical gloves;natural rubber latex; nitrile; performance; physical properties;polychloroprene; quality; selection; vinylD7103 06 (2013)3ASTM International takes no position respecting the validity of a

47、ny 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 subject to re

48、vision 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 Headquarters. You

49、r 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 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), 610-83