ASTM D6978-2005 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs《防化学理疗药物渗透的医用手套的评定的标准实施规程》.pdf

1、Designation: D 6978 05Standard Practice forAssessment of Resistance of Medical Gloves to Permeationby Chemotherapy Drugs1This standard is issued under the fixed designation D 6978; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, th

2、e year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This practice covers a protocol for the assessment ofresistance of medical glove materials to permeation by

3、 poten-tially hazardous cancer chemotherapy drugs under conditionsof continuous contact. An assessment is made based on thepermeation (breakthrough) of nine chemotherapy drugsthrough the glove material over a certain period of time.1.2 It is emphasized that the conditions used in this assess-ment ar

4、e intended to approximate the worst-case condition forclinical uses. The data should be restricted to use on a relativebasis when comparing glove materials.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

5、 this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D 471 Test Method for Rubber PropertyEffect of LiquidsD 3577 Specification for Rubber Surgical GlovesD 3578 Specific

6、ation for Rubber Examination GlovesD 3767 Practice for RubberMeasurement of DimensionsD 5250 Specification for Poly(Vinyl Chloride) Gloves forMedical ApplicationD 6319 Specification for Nitrile Examination Gloves forMedical ApplicationD 6977 Specification for Polychloroprene ExaminationGloves for Me

7、dical ApplicationF 739 Test Method for Resistance of Protective ClothingMaterials to Permeation by Liquids or Gases Under Con-ditions of Continuous Contact3. Terminology3.1 DefinitionsSee Test Method F 739, Section 3 onTerminology for a full list of terms and definitions.3.1.1 breakthrough detection

8、 time, nthe time in minutesmeasured from the start of the test to the sampling time thatimmediately precedes the sampling time at which the perme-ation rate reaches 0.01 g/cm2/min. See Test Method F 739,section 12.4.2 for calculation of permeation rate with replen-ishment.3.1.2 validated statistical

9、 rationale, nrequires that anobjective cause or reason be stated as to why the initial test wasincorrect.4. Significance and Use4.1 The objective of this practice is to provide a uniformprocedure for assessing the resistance of medical glove mate-rials to permeation by chemotherapy drugs, and to est

10、ablish aconsistent reporting of the test data.5. Test Protocol5.1 Summary of Test Method:5.1.1 The gloves in question shall be tested in accordancewith the method set out in Test Method F 739, Procedure A.5.1.2 The resistance of a medical glove material to perme-ation by chemotherapy drugs shall be

11、determined by measuringthe breakthrough detection time of the drugs through the glovematerial. The test method involves using the test material serveas a membrane (partition) between the two halves of a test cell.One half of the cell shall contain the donor solution of the testdrug and the other hal

12、f shall contain the appropriate collectionmedium, that is, distilled water or other liquid, which does notinfluence the permeation of the drug being tested. A test drugpermeates through the sample material when the test drug isable to pass through the test material. As the test drugcontinuously pass

13、es through the sample material, its concen-tration increases over time. The collection medium shall besampled at recorded time intervals and analyzed quantitativelyto determine the concentration of the permeated drug. Theconcentration of the drug in the collection medium shall beused to calculate th

14、e breakthrough detection time and perme-ation rate (see 3.1.2), in accordance with Test Method F 739.5.2 Test Protocol:5.2.1 Test Material Selection:5.2.1.1 Three medical gloves that meet the appropriateASTM standards (Specifications D 3577, D 3578, D 5250,D 6319, and D 6977) shall be selected and u

15、sed to produce test1This practice 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 April 1, 2005. Published April 2005.2For referenced ASTM standards, visit the ASTM website, www.astm

16、.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.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.samples. M

17、anually measure each glove thickness with athickness gage that has a presser foot pressure that meets therequirement of Practice D 3767, and graduations to 20 m. Foreach medical glove, record manual thickness measurementsfrom two distinct areas of the medical glove: palm and cuff.From these measurem

18、ents determine the thinner area of theglove between the palm and cuff. Obtain test samples from thethinner area of the glove.5.2.1.2 Cut one 5 by 5-cm piece of material from the palmor cuff of each test medical glove, whichever area measuredthinnest. Identify the outer side of the sample.5.2.1.3 One

19、 test sample shall be obtained from each of thethree test medical gloves. As a result, there will be a minimumof 27 test samples obtained when testing against the nine testdrugs. The number of test drugs, nine, is a minimum.5.2.2 Representative Drugs to be Tested:5.2.2.1 The chemotherapy drugs used

20、in testing shall incor-porate the different classes of clinical drugs. The number ofdrugs tested shall reflect a minimum of nine currently usedclinical drugs.5.2.2.2 The clinical drugs selected shall include at least thefollowing seven drugs: Carmustine, Cyclophosphamide, Doxo-rubicin, Etoposide, Fl

21、uorouracil, Paclitaxel, and Thiotepa. SeeTable 1.5.2.2.3 The testing shall be completed with an additionaltwo clinical drugs that can be selected by the user of thispractice. Table 2 is available as a guide for selecting additionalchemotherapy drugs.5.2.2.4 The clinical drugs called for in this prac

22、tice shall bepurchased from pharmaceutical drug manufacturers or autho-rized distributors of pharmaceuticals. Each test drug shall beprepared using the manufacturers recommended solvent. Thepreparation procedure shall be documented.5.2.2.5 The drug solution shall be prepared with the recom-mended so

23、lvent and at the highest concentration of the drug towhich a healthcare worker might be exposed during handlingas referenced in the most recent edition of Physicians DeskReference, or the package insert of the test drug (see Table 1).5.2.3 Test Conditions:5.2.3.1 The test shall be conducted at 35 6

24、2C and thetemperature recorded.5.2.3.2 The outer surface of the glove material shall contactthe donor solution of the test drug.5.2.3.3 The collection medium shall be mixed continuously.5.2.3.4 The test duration shall be 4 h, during which analiquot of an appropriate volume of the collection mediumsh

25、all be removed at least every 30 min from the collection cellfor the measurement of the concentration of the test drug in thecollection medium based on drug manufacturers recom-mended detection method.5.2.3.5 The collection cell shall be replenished immediatelywith the same volume of the liquid remo

26、ved from the collec-tion medium.5.2.4 Test Termination:5.2.4.1 The test shall be terminated after 4 h.5.2.4.2 The breakthrough shall be deemed to have occurredwhen the quantitative analysis based on drug manufacturersrecommended detection method, detects a permeation rate of0.01 g/cm2/min.5.2.4.3 Ea

27、ch test glove material shall be inspected at the endof the test period for physical changes, such as signs of flaking,swelling, disintegration, embrittlement, discoloration, or otherphysical changes. The changes shall be recorded in accordancewith Test Method D 471.6. Expression of Test Results6.1 T

28、he minimum breakthrough detection time (the time,expressed in minutes, at which the permeation rate reaches0.01 g/cm2/min; see 3.1.1) of each of the nine drugs testedduring the 4-h test duration, as determined from the triplicatesample tested (see 5.2.1.3), shall be reported for each glovematerial.6

29、.2 If retesting is going to be performed, an objectiverationale shall be provided addressing why the original data isnot an outlier or is not correct. This rationale shall have avalidated statistical basis (see 3.1.2).7. Report7.1 For each glove material tested, a report shall be preparedthat descri

30、bes the resistance of the medical glove material tothe drugs tested (see 6.1 and 6.2) and the information of thegloves used for testing. The report shall include at least thefollowing:7.1.1 The glove manufacturers reference for the glovematerial submitted for test, that is, type of glove (for exampl

31、e,examination or surgeons gloves), glove material (for example,natural rubber latex, nitrile, and so forth), glove physicalspecifications (for example, tensile strength, elongation), pin-hole AQL, lot, and batch number,TABLE 1 List of the Required Chemotherapy Drugs and TheirConcentrations as Typica

32、lly Prepared for Clinical UseChemotherapy Drugs Concentration (mg/mL)ACarmustine 3.3Cyclophosphamide 20.0Doxorubicin HCl (Adriamycin) 2.0Etoposide 20.0Fluorouracil (Adrucil) 50.0Paclitaxel (Taxol) 6.0ThioTEPA 10.0AInitial reconstitution or commercially available concentration.TABLE 2 Sample List of

33、Additional Chemotherapy Drugs andTheir Concentrations as Typically Prepared For Clinical UseChemotherapy Drugs Concentration (mg/mL)ABleomycin sulfate 15.0Carboplatin 10.0Cisplatin 1.0Cytarabine HCl 100.0Dacarbazine 10.0Daunorubicin HCl 5.0Docetaxel 10.0Gemcitabine 38.0Idarubicin 1.0Ifosfamide 50.0I

34、rinotecan 20.0Mechlorethamine HCl 1.0Melphalan 5.0Methotrexate 25.0Mitomycin 0.5Mitoxantrone 2.0Vincristine sulfate 1.0AInitial reconstitution or commercially available concentration.D69780527.1.2 The location of the area (that is, palm or cuff) wherethe 5 by 5-cm glove material specimen was obtaine

35、d fortesting,7.1.3 The thickness of the test sample measured manuallywithin nearest 20-m graduation,7.1.4 The name of the nine clinical drugs tested, name ofmanufacturers, lot number, expiration date, the concentration(mg/mL) at which the drug is tested, and the chemical name ofthe solvent used,7.1.

36、5 The solvent used as a collection medium (for example,distilled water or other liquids),7.1.6 The breakthrough detection time (see 3.1.1),7.1.7 If no permeation was detected or the permeation ratedid not reach 0.01 g/cm2/min, report the fact that no perme-ation was detected or that the permeation r

37、ate did not reach theprescribed permeation rate of 0.01 g/cm2/min during the 4-htest period,7.1.8 Whether permeation takes place or not, the duration ofthe test period shall be reported (for example, 4 h), and7.1.9 Any observed physical changes of the test samplesshall be documented. Such physical c

38、hanges include but arenot limited to signs of flaking, swelling, disintegration, em-brittlement, or discoloration in accordance with Test MethodD 471.8. Keywords8.1 breakthrough detection time; chemotherapy; patient ex-amination glove; permeation rate; surgeons gloveBIBLIOGRAPHY(1) American Society

39、of Health-Systems Pharmacists (ASHP), “TechnicalAssistance Bulletin on Handling of Cytotoxic and Hazardous Drugs,”1990.(2) BS/EN 374-3, “Protective Gloves Against Chemicals and Micro-organisms; Part 3, Determination of Resistance to Permeation byChemicals,” 1999.(3) Connor, T. H., “Permeability of N

40、itrile Rubber, Latex, Polyurethane,and Neoprene Gloves to 18 Antineoplastic Drugs,” American Journalof Health-System Pharmacy, Vol 56, 1999, pp. 2450-2453.(4) HHS Publications FDA 96-4257, “Guidance for Medical Gloves: AWorkshop Manual,” September 1996.(5) Klein, M., Lambov, N., Samev, N., et al., “

41、Permeation of CytotoxicFormulations Through Swatches from Selected Medical Gloves,”American Journal of Health-System Pharmacy, Vol 60, 2003, pp.1006-1011.(6) Klinger, T., Boeniger, M., “In-use Testing and Interpretation ofChemical-Resistant Glove Performance,” Applied Occupational andEnvironmental H

42、ygiene, Vol 17(5), 2002, pp. 368-378.(7) Occupational Safety and Health Administration (OSHA), PUB 8-1-1-Guidelines for Cytotoxic (Antineoplastic) Drugs, 1990.(8) Oncology Nursing Society (ONS), “Safe Handling of CytotoxicDrugs,” Independent Study Module, 1997.(9) Physicians Desk Reference (PDR), cu

43、rrent edition.(10) 29 CFR 1910.1030, Bloodborne Pathogens, Appendix A.(11) Singleton, L., and Connor, T. H., “An Evaluation of the Permeabilityof Chemotherapy Gloves to Three Cancer Chemotherapy Drugs,”Oncology Nursing Forum, Vol 26, 1999, pp. 1491-1496.ASTM International takes no position respectin

44、g 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 infringement of such rights, are entirely their own responsibility.This standa

45、rd 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 for additional standardsand should be addressed to ASTM Internationa

46、l 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 the address shown below.Th

47、is 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).D6978053