ASTM_F_749_-_13.pdf

Designation:F74913Standard Practice forEvaluating Material Extracts by Intracutaneous Injection inthe Rabbit1This standard is issued under the fixed designation F749;the number immediately following the designation indicates the year of originaladoption or,in the case of revision,the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This practice is a nonspecific,acute toxicity test used tohelp determine the biocompatibility of materials used inmedical devices.1.2 The liquids injected into the rabbits are those obtainedby Practice F619 where the extraction vehicles are saline,vegetable oil,or other liquids simulating human body fluids.1.3 This practice is one of several developed for theassessment of the biocompatibility of materials.Practice F748may provide guidance for the selection of appropriate methodsfor testing materials for a specific application.1.4 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.2.Referenced Documents2.1 ASTM Standards:2F619 Practice for Extraction of Medical PlasticsF748 Practice for Selecting Generic Biological Test Methodsfor Materials and Devices3.Summary of Practice3.1 The extract liquid is prepared in accordance with Prac-tice F619.The extraction vehicles are saline and vegetable oil,or other extraction vehicles can be used,as described inPractice F619.The extract liquid is injected into rabbits and theanimals are observed at regular intervals for 72 h for erythema,edema,or necrosis.4.Significance and Use4.1 This practice is to be used to help assess the biocom-patibility of materials used in medical devices.It is an acutetoxicological test designed to detect the presence of injuriousleachable substances.4.2 This practice may not be appropriate for all types ofimplant applications.The user is cautioned to consider theappropriateness of the method in view of the materials beingtested,their potential applications,and the recommendationscontained in Practice F748.4.3 The only applicable limitation is the extract preparation.Refer to Sections 4.3 and 4.4 of Practice F619 for a descriptionof this limitation.5.Apparatus5.1 CagesThere shall be one cage for each rabbit exposedto one extract liquid.Each rabbit shall be uniquely identifiedwith this identity recorded.5.2 SyringesSterile syringes,not greater than 2 mL involume,with a precision of no less than 60.10 mL shall beused.Sterile needles of 21 to 26 gauge shall be used.6.Test Animals6.1 RabbitsThe rabbits shall be healthy thin-skinned al-bino type,not previously used for any test.Animal care shall bein accordance with Guide for Care and Use of LaboratoryAnimals.3Rabbits with significant scars or wounds are notsuitable for this test.For each extraction vehicle,a minimum ofthree rabbits are used in the test.If the results of the first testare inconclusive,three more rabbits will be needed to completethe test with that extraction vehicle for one material.6.1.1 During the test the rabbits shall be fed normally,withcommercially available feed and tap water.1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.16 on Biocompatibility Test Methods.Current edition approved March 1,2013.Published March 2013.Originallyapproved in 1982.Last previous edition approved in 2012 as F749 98(2012).DOI:10.1520/F0749-13.2For 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.3The Guide for Care and Use of Laboratory Animals,Institute of LaboratoryAnimal Research Publication.Available from National Academy Press,500 FifthSt.,NW,Lockbox 285,Washington,DC 20055.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 7.Sampling7.1 Sample in accordance with Practice F619.8.Sample and Test Specimen8.1 The sample is the extract of the test article(that is,plastic or other material)exposed to the extraction procedure.As a result of the extraction in Practice F619,for eachextraction vehicle there are available:(1)sample extract liquid,and(2)a blank extract liquid.These extract liquids are to beinjected into the test animals within 24 h of the end of theextraction procedure.Record storage conditions if not usedimmediately after preparation.8.1.1 There are usually four extract liquids prepared fromtwo extraction vehicles available for test,those based on salineand vegetable oil.Samples based on other extraction vehiclesmay be available,as described in Practice F619,or as requiredby the standard for the medical device.8.2 The test specimen is the combination of the test site and0.2 mL of the injected extract liquid.A total of 10