ASTM D7103-2006 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: D 7103 06Standard Guide forAssessment of Medical Gloves1This standard is issued under the fixed designation D 7103; 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 ind

2、icates the year of last reapproval. Asuperscript epsilon (e) 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, development of s

3、pecifications,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 guarantees healt

4、h-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 evaluation of avail

5、abletechnical 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 practices and deter

6、mine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D 412 Test Methods for Vulcanized Rubber and Thermo-plastic ElastomersTensionD 573 Test Method for RubberDeterioration in an AirOvenD 3577 Specification for Rubber Surgical GlovesD 3578 Specific

7、ation for Rubber Examination GlovesD 3767 Practice for RubberMeasurement of DimensionsD 5151 Test Method for Detection of Holes in MedicalGlovesD 5250 Specification for Poly(vinyl chloride) Gloves forMedical ApplicationD 5712 Test Method for Analysis of Aqueous ExtractableProtein in Natural Rubber a

8、nd Its Products Using theModified Lowry MethodD 6124 Test Method for Residual Powder on MedicalGlovesD 6319 Specification for Nitrile Examination Gloves forMedical ApplicationD 6499 Test Method for The Immunological Measurementof Antigenic Protein in Natural Rubber and its ProductsD 6977 Specificati

9、on for Polychloroprene ExaminationGloves for Medical ApplicationF 739 Test Method for Resistance of Protective ClothingMaterials to Permeation by Liquids or Gases Under Con-ditions of Continuous ContactF 1342 Test Method for Protective Clothing Material Resis-tance to PunctureF 1383 Test Method for

10、Resistance of Protective ClothingMaterials to Permeation by Liquids or Gases Under Con-ditions of Intermittent ContactF 1671 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 America

11、n 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. 103 N

12、on-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 EmergencyMedical Oper

13、ations43. Terminology3.1 Definitions:1This 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 2006.2For referenced ASTM standards, visit the ASTM we

14、bsite, 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), 25 W. 43rd St.,4th Floor, New York, NY 10036.4Av

15、ailable from National Fire Protection Association (NFPA), 1 BatterymarchPark, Quincy, MA 02269-9101.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.1.1 medical glovessurgeons (surgical) and patient ex-amination (examination) gloves

16、 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).3.1.3 syntheic plastic glovesgloves manufactured from asynthetic plastic mat

17、erial 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) polychloroprene and (2)acrylonitrile butadiene (nitrile).3.1.4.1 DiscussionThe act

18、ual 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 integrated protocol in the assessment andselection of medical gloves.4.2 The intend

19、ed 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 methods offer procedures for assessing medicalgloves at standardized conditions to

20、 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.4.6 Medical gloves intended for use during emergencymedical operations may be ev

21、aluated 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 glove standards providesminimum quality specifications for the medical glove that

22、 itdescribes: Specifications D 3577, D 3578, D 5250, D 6319,and D 6977.5.2 Each medical glove standard listed in 5.1 also providesmaterial-specific performance specifications.5.3 Each of the medical glove standards listed in 5.1contains minimum quality standards, which include an as-signed inspectio

23、n level and AQL (acceptable quality level) perISO 2859 for each of the following:5.3.1 Holes:5.3.1.1 Test Method D 5151 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 wh

24、en assessing medical gloves for holes.5.3.2 Dimensions:5.3.2.1 Practice D 3767 describes how to properly deter-mine the geometrical dimensions of rubber products forphysical tests.5.3.2.2 Each medical glove standard listed in 5.1 providesmaterial specific specifications for palm width, length, andth

25、ickness.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 test that measures the stress at 500 %elongation.5.3.3.1 This test m

26、easure is determined by measuring thestress at 500 % elongation in accordance with Test MethodsD 412.5.3.3.2 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 D 412.5.3.3.4 After acc

27、elerated aging tests are performed in accor-dance with Test Method D 573.6. Assessment of Powder Residue on Powder-freeMedical Gloves6.1 The powder residue on powder-free medical glovesshall be measured in accordance with Test Method D 6124.6.2 The recommended powder residue limit for powder-freemed

28、ical 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 D 6124.7.2 The recommended powder amount limit for powderedexamination gloves is not more tha

29、n 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 dm2=square decimetre.8. Assessment of Extractable Protein for Na

30、tural RubberLatex Medical Gloves8.1 In accordance with Specification D 3578, the content ofaqueous soluble protein in natural rubber latex medical glovesshall be determined using Test Method D 5712.NOTE 2The FDA requires that Test Method D 5712 be performed insupport of a 510(k) Premarket Notificati

31、on submission.8.2 The recommended aqueous soluble protein content limitfor natural rubber latex medical gloves is not more than 200g/dm2.8.2.1 This recommended aqueous soluble protein contentlimit is in accordance with the performance requirements setforth in the performance requirements section of

32、SpecificationD 3578.8.3 The FDA regulates extractable protein content labelclaims. The lowest protein content label allowed by the FDAis50 g/g of glove.D71030629. Assessment of Antigenic Protein for Natural RubberLatex Medical Gloves9.1 In accordance with Specification D 3578, the amount ofextractab

33、le antigenic protein in natural rubber latex medicalgloves shall be determined using Test Method D 6499.9.2 The recommended antigenic protein content limit fornatural rubber latex medical gloves is not more than 10 g/dm2per Test Method D 6499.9.2.1 This recommended antigenic protein content limit is

34、in accordance with the performance requirements set forth inthe performance requirements section of Specification D 3578.10. Assessment of Resistance to Viral Penetration10.1 Medical gloves may be evaluated for resistance to viralpenetration in accordance with Test Method F 1671.10.1.1 Test Method F

35、 1671 measures the resistance ofmaterials to penetration by blood-borne pathogens using asurrogate microbe under conditions of continuous liquid con-tact.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 specifically def

36、ined 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 material may b

37、e 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 F 739) and intermittentcontact (Test Method F 1383).11.1.1 Test Method F 739:11.1.1.1 This test method

38、 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 F 739 allows several configurations ofthe test,

39、 including the choice of collection media, detectionsystems, the test temperature, and length of the test.11.1.2 Test Method F 1383:11.1.2.1 This test method is a variation of Test MethodF 739 and is used to measure breakthrough detection time andpermeation rate through material specimens under the

40、condi-tions of intermittent contact of the test chemical with thematerial specimen.11.1.2.2 Test Method F 1383 is designed to simulate thetype of chemical exposures where chemical contact occursthrough periodic exposure through repeated splashes depend-ing on the type of task in which the healthcare

41、 worker isinvolved.12. Assessment of Puncture Resistance12.1 The puncture resistance of elastomeric materials suchas those used to manufacture medical gloves can be testedusing Test Method F 1342.12.1.1 Test Method F 1342 measures the puncture resis-tance of a material specimen by measuring the forc

42、e requiredto cause a specifically defined puncture probe to penetratethrough the material specimen.NOTE 3Test Method F 1342 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 s

43、tandard 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 requiremen

44、ts 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 Medical

45、 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. Keyword

46、s16.1 assessment; barrier properties; latex; medical gloves;natural rubber latex; nitrile; performance; physical properties;polychloroprene; quality; selection; vinylASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin thi

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49、onsible 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 the ASTM website(www.