1、Designation:F81307(Reapproved 2012)Standard Practice forDirect Contact Cell Culture Evaluation of Materials forMedical Devices1This standard is issued under the fixed designation F813;the number immediately following the designation indicates the year of originaladoption or,in the case of revision,t
2、he 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 reference method of direct contactcell culture testing which may be used in evaluating thec
3、ytotoxic potential of materials for use in the construction ofmedical materials and devices.1.2 This practice may be used either directly to evaluatematerials or as a reference against which other cytotoxicity testmethods may be compared.1.3 This is one of a series of reference test methods for thea
4、ssessment of cytotoxic potential,employing different tech-niques.1.4 Assessment of cytotoxicity is one of several testsemployed in determining the biological response to a material,as recommended in Practice F748.1.5 The L-929 cell line was chosen because it has asignificant history of use in assays
5、 of this type.This is notintended to imply that its use is preferred;only that the L-929is a well-characterized,readily available,established cell linethat has demonstrated reproducible results in several laborato-ries.1.6 Since the test sample is not removed at the time ofmicroscopic evaluation and
6、 underlying cells may be affectedby the specific gravity of the test sample,this practice is limitedto evaluation of cells outside the perimeter of the overlying testsample.1.7 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.8
7、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 determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents
8、2.1 ASTM Standards:2F619 Practice for Extraction of Medical PlasticsF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF895 Test Method forAgar Diffusion Cell Culture Screeningfor CytotoxicityF1027 Practice for Assessment of Tissue and Cell Compat-ibility of Orofacia
9、l Prosthetic Materials and Devices2.2 Other Documents:The American Type Culture Collection(ATCC),Catalogueof Strains II3USP Negative Control Plastic Reference Standard43.Summary of Practice3.1 Cell cultures are grown to a confluent monolayer inculture dishes.The growth medium is aspirated and replen
10、-ished to provide a resting,confluent cell layer.Test and controlspecimens are placed in direct contact with the cell layer toprovide an accelerated assessment of the presence or absenceof a cytotoxic effect from a given material or device.SeePractice F1027 for definitions.4.Significance and Use4.1
11、This practice is useful for assessing cytotoxic potentialboth when evaluating new materials or formulations forpossible use in medical applications,and as part of a qualitycontrol program for established medical materials and medicaldevices.4.2 This practice assumes that assessment of cytotoxicitypo
12、tential provides one method for predicting the potential forcytotoxic or necrotic reactions to medical materials and devicesduring clinical applications to humans.In general,cell culturetesting methods have shown good correlation with animalassays and are frequently more sensitive to toxic moieties.
13、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 November 2012.Originallyapproved in 2001.Last previous edit
14、ion approved in 2007 as F813 07.DOI:10.1520/F0813-07R12.2For 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.3American
15、Type Culture Collection,P.O.Box 1549,Manassas,VA 20108.4U.S.Pharmacopeia,Vol 24,Rand McNally,Taunton,MA,1994,pp.16521653.Use latest publication to ensure current cumulative revisions are used.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States
16、1 4.3 This cell culture test method is suitable for adoption inspecifications and standards for materials for use in theconstruction of medical devices that are intended to be im-planted in the human body or placed in contact with tissue,tissue fluids,or blood on a long-term basis.However,careshould be taken when testing materials that are resorbable to besure the method is applicable.4.4 Since cells in this direct contact test method are notprotected by an overlying agarose layer,they are more
