1、Designation: D6978 05 (Reapproved 2013)Standard Practice forAssessment of Resistance of Medical Gloves to Permeationby Chemotherapy Drugs1This standard is issued under the fixed designation D6978; the number immediately following the designation indicates the year oforiginal adoption or, in the case
2、 of revision, the year 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 practice covers a protocol for the assessment ofresistance of medical glove materials t
3、o permeation by 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
4、 assess-ment are 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
5、 of the user of 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:2D471 Test Method for Rubber PropertyEffect of LiquidsD3577 Specification for Rubber Surgical GlovesD3
6、578 Specification for Rubber Examination GlovesD3767 Practice for RubberMeasurement of DimensionsD5250 Specification for Poly(vinyl chloride) Gloves forMedical ApplicationD6319 Specification for Nitrile Examination Gloves forMedical ApplicationD6977 Specification for Polychloroprene ExaminationGlove
7、s for Medical ApplicationF739 Test Method for Permeation of Liquids and Gasesthrough Protective Clothing Materials under Conditions ofContinuous Contact3. Terminology3.1 Definitions:3.1.1 See Test Method F739, Section 3 on Terminology fora full list of terms and definitions.3.1.2 breakthrough detect
8、ion 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 F739,section 12.4.2 for calculation of permeation rate with replen-ishment.3.1.3 validated statistic
9、al rationale, n requires 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
10、establish 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 F739, Procedure A.5.1.2 The resistance of a medical glove material to perme-ation by chemotherapy drugs shall b
11、e 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 h
12、alf 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 pa
13、sses 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
14、the breakthrough detection time and perme-ation rate (see 3.1.3), in accordance with Test Method F739.1This 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 Jan. 1, 2013. Pub
15、lished April 2013. Originallyapproved in 2005. Last previous edition approved in 2005 as D6978 05. DOI:10.1520/D6978-05R13.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, re
16、fer to the standards Document Summary page onthe ASTM website.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States15.2 Test Protocol:5.2.1 Test Material Selection:5.2.1.1 Three medical gloves that meet the appropriateASTM standards (Specif
17、ications D3577, D3578, D5250,D6319, and D6977) shall be selected and used to produce testsamples. Manually measure each glove thickness with athickness gage that has a presser foot pressure that meets therequirement of Practice D3767, and graduations to 20 m. Foreach medical glove, record manual thi
18、ckness measurementsfrom two distinct areas of the medical glove: palm and cuff.From these measurements 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
19、 medical glove, whichever area measuredthinnest. Identify the outer side of the sample.5.2.1.3 One 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 drug
20、s, nine, is a minimum.5.2.2 Representative Drugs to be Tested:5.2.2.1 The chemotherapy drugs used 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 in
21、clude at least thefollowing seven drugs: Carmustine, Cyclophosphamide,Doxorubicin, Etoposide, Fluorouracil, Paclitaxel, and Thio-tepa. See Table 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 g
22、uide for selecting additionalchemotherapy drugs.5.2.2.4 The clinical drugs called for in this practice shall bepurchased from pharmaceutical drug manufacturers or autho-rized distributors of pharmaceuticals. Each test drug shall beprepared using the manufacturers recommended solvent. Thepreparation
23、procedure shall be documented.5.2.2.5 The drug solution shall be prepared with the recom-mended solvent 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
24、 of the test drug (see Table 1).5.2.3 Test Conditions:5.2.3.1 The test shall be conducted at 35 6 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
25、 duration shall be 4 h, during which analiquot of an appropriate volume of the collection mediumshall 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
26、.2.3.5 The collection cell shall be replenished immediatelywith the same volume of the liquid removed 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 dru
27、g manufacturersrecommended detection method, detects a permeation rate of0.01 g/cm2/min.5.2.4.3 Each 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. Th
28、e changes shall be recorded in accordancewith Test Method D471.6. Expression of Test Results6.1 The minimum breakthrough detection time (the time,expressed in minutes, at which the permeation rate reaches0.01 g/cm2/min; see 3.1.2) of each of the nine drugs testedduring the 4-h test duration, as dete
29、rmined from the triplicatesample tested (see 5.2.1.3), shall be reported for each glovematerial.6.2 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 bas
30、is (see 3.1.3).7. Report7.1 For each glove material tested, a report shall be preparedthat describes the resistance of the medical glove material toTABLE 1 List of the Required Chemotherapy Drugs and TheirConcentrations as Typically Prepared for Clinical UseChemotherapy DrugsConcentration (mg/mL)ACa
31、rmustine 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 Additional Chemotherapy Drugs andTheir Concentrations as Typically Prepa
32、red For Clinical UseChemotherapy DrugsConcentration (mg/mL)ABleomycin sulfate 15.0Carboplatin 10.0Cisplatin 1.0Cytarabine HCl 100.0Dacarbazine 10.0Daunorubicin HCl 5.0Docetaxel 10.0Gemcitabine 38.0Idarubicin 1.0Ifosfamide 50.0Irinotecan 20.0Mechlorethamine HCl 1.0Melphalan 5.0Methotrexate 25.0Mitomy
33、cin 0.5Mitoxantrone 2.0Vincristine sulfate 1.0AInitial reconstitution or commercially available concentration.D6978 05 (2013)2the 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 f
34、or the glovematerial submitted for test, that is, type of glove (for example,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,7.1.2
35、The location of the area (that is, palm or cuff) wherethe 5 by 5-cm glove material specimen was obtained 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 da
36、te, the concentration(mg/mL) at which the drug is tested, and the chemical name ofthe solvent used,7.1.5 The solvent used as a collection medium (for example,distilled water or other liquids),7.1.6 The breakthrough detection time (see 3.1.2),7.1.7 If no permeation was detected or the permeation rate
37、did not reach 0.01 g/cm2/min, report the fact that no perme-ation was detected or that the permeation rate 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 exampl
38、e, 4 h), and7.1.9 Any observed physical changes of the test samplesshall be documented. Such physical changes include but arenot limited to signs of flaking, swelling, disintegration,embrittlement, or discoloration in accordance with TestMethod D471.8. Keywords8.1 breakthrough detection time; chemot
39、herapy; patient ex-amination glove; permeation rate; surgeons gloveBIBLIOGRAPHY(1) American Society of Health-Systems Pharmacists (ASHP), “Techni-cal Assistance Bulletin on Handling of Cytotoxic and HazardousDrugs,” 1990.(2) BS/EN 374-3, “Protective Gloves Against Chemicals and Micro-organisms; Part
40、 3, Determination of Resistance to Permeation byChemicals,” 1999.(3) Connor, T. H., “Permeability of Nitrile 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
41、 for Medical Gloves: AWorkshop Manual,” September 1996.(5) Klein, M., Lambov, N., Samev, N., et al., “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 Testi
42、ng and Interpretation ofChemical-Resistant Glove Performance,” Applied Occupational andEnvironmental Hygiene, 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), “Sa
43、fe Handling of CytotoxicDrugs,” Independent Study Module, 1997.(9) Physicians Desk Reference (PDR), current 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 Dru
44、gs,”Oncology Nursing Forum , Vol 26, 1999, pp. 1491-1496.ASTM International takes no position respecting 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 paten
45、t 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 and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited eithe
46、r for revision of this standard or for additional standardsand should be addressed 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 he
47、aring 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 standar
48、d 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). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/).D6978 05 (2013)3
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