ASTM_F_750_-_87_2012.pdf

Designation:F75087(Reapproved 2012)Standard Practice forEvaluating Material Extracts by Systemic Injection in theMouse1This standard is issued under the fixed designation F750;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 covers a nonspecific,acute toxicity testused for detecting leachables from materials used in medicaldevices.1.2 The liquids injected into the mouse are those obtainedby Practice F619 where the extraction vehicles are saline,vegetable oil,or other liquids simulating human body fluids.1.3 Two procedures are outlined:Method A for intravenousinjection and Method B for intraperitoneal injection.1.4 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.1.5 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,as described in Practice F619.Theextract liquid is injected into mice,and the animals areobserved at regular intervals for 72 h for reactions,survival,etc.4.Significance and Use4.1 This practice is intended to help assess the biocompat-ibility 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 limitation applicable is the extract preparation.Refer to Sections 4.3 and 4.4 of Practice F619 for a descriptionof this limitation.5.Apparatus5.1 MiceThe mice shall be albino-type,healthy and notpreviously used,and shall weigh between 17 and 23 g.Animalcare shall be in accordance with the“Guide for Care and Useof Laboratory Animals.”3Age,sex,and weight shall berecorded and reported.All the mice for each extraction vehicleshall be from the same source.For each extraction vehicle,aminimum of ten mice are used in the test.If the results of thisfirst test group are inconclusive,then 20 more mice will beneeded to complete the test of one extraction vehicle for oneplastic.5.1.1 During the test the mice shall be fed normally withcommercially available feed and tap water.5.2 CagesThere shall be one cage for the five miceexposed to one extract liquid.Each mouse in a cage shall beuniquely identified,and this identification shall be recorded.Male and female mice shall be housed separately,and theircages are positioned in a manner which prevents the accidentaltransfer of feces or bedding from cage to cage.5.3 SyringeSterile syringes,not greater than 3 mL involume,with a precision of 60.10 mL shall be used.5.3.1 Method ASterile needles of 25 to 2712gage shall beused.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 Oct.1,2012.Published October 2012.Originallyapproved in 1982.Last previous edition approved in 2007 as F750 87(2007)1.DOI:10.1520/F0750-87R12.2For 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.3U.S.Department of Health,Education,and Welfare,Guide for Care and Use ofLaboratory Animals,Publication No.NIH 78-23,Bethesda,MD,1978.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 5.3.2 Method BSterile needles of 21 to 26 gage shall beused.6.Sampling6.1 Sample in accordance with Practice F619.7.Sample and Test Specimen7.1 GeneralThe sample is the plastic or other materialexposed to the extraction procedure.As a result of theextraction in Practice F619,for each extraction vehicle thereare available:(1)a sample extract liquid,and(2)a blankextract liquid.These extract liquids are to be injected into thetest animals within 24 h of the end of the extraction procedure.Record the storage conditions if the liquid extract is not usedimmediately after preparation.7.1.1 There are usually two extract liquids(a blank and asample)prepar