ASTM_F_2151_-_01.pdf

Designation:F 2151 01Standard Practice forAssessment of White Blood Cell Morphology After Contactwith Materials1This standard is issued under the fixed designation F 2151;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the 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 provides a protocol for the assessment ofthe effect of materials used in the fabrication of medicaldevices,that will contact blood,on the morphology of whiteblood cells.1.2 This practice is intended to evaluate the acute in vitroeffects of materials intended for use in contact with blood.1.3 This practice uses direct contact of the material withblood,and extracts of the material are not used.1.4 This practice is one of several developed for theassessment of the biocompatibility of materials.Practice F 748provides general guidance for the selection of appropriatemethods for testing materials for a specific application.1.5 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.1.6 Identification of a supplier of materials or reagents isfor the convenience of the user and does not imply singlesource.Appropriate materials and reagents may be obtainedfrom many commercial supply houses.2.Referenced Documents2.1 ASTM Standards:F 619 Practice For Extraction Of Medical Plastics2F 748 Practice For Selecting Generic Biological Test Meth-ods For Materials And Devices2F 756 Practice for Assessment of Hemolytic Properties ofMaterials23.Terminology3.1 Definitions:3.1.1 control material,na material such as low densitypolyethylene(LDPE)which is expected to have minimal effecton the morphology of white blood cells.3.1.2 nuclear damage,nfor the white blood cell morphol-ogy test,this term us used to describe the nucleus of a whiteblood cell appears to be condensed,fragmented or lysed;forthe White Blood Cell Morphology Test.This includes nucleardamage that might be classified as karyolysis,karyorrhexis,pyknosis,or simply necrosis.3.1.3 positive control material,na material such as latex(gloves,dental dam,or tubing)or TSV,tin-stabilized vinyl(slab),which is expected to have an adverse effect on themorphology of white blood cells.3.2 Abbreviations:3.2.1 Bbasophil3.2.2 BRbroken or lysed3.2.3 Eeosinophil3.2.4 INDNMindistinct nuclear membrane:a degenera-tive change of the nucleus;for the White Blood Cell Morphol-ogy Test,this term is used to describe a nuclear membrane thatis rough,ragged,or torn3.2.5 Llymphocyte3.2.6 Mmonocyte3.2.7 Nneutrophil3.2.8 UNIDunidentified4.Summary of Practice4.1 Test and control material specimens are exposed tocontact with canine blood under defined static conditions andthe effect on blood cell morphology is determined.The use ofhuman blood is permissible if the laboratory is knowledgeableof precautions needed to handle human blood.If a source ofblood other than canine or human is used,consideration shouldbe given to the differences in hematologic values and morphol-ogy differences between that species and humans.5.Significance and Use5.1 The presence of material in contact with the blood maycause damage to white blood cells resulting in changes infunction of these cells or changes in properties of the blood.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.10,2001.Published March 2002.2Annual Book of ASTM Standards,Vol 13.01.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.5.2 This practice may not be predictive of events occurringduring all types of blood contacting applications.The user iscautioned to consider the appropriateness of the method inview of the materials being tested,their potential applications,and the recommendations contained in Practice F 748.Thepropensity of a material to cause hemolysis should be ad-dressed according to Practice F 756.6.Preparation of Test and Control Specimens6.1 Specimen samples should be prepared according toPractice F 619.Direct contact of the material with blood willbe studied,the blood is the extractant,and other extracts of thematerial are not used.Prepare a sample size such that 1 mL ofblood is used.If the sample size is such that larger volumes ofblood are needed,this is permissible but note in the report.Thisscale up would be based on an expected sample size of 3cm2/mL.6.2 The final sample should be prepared with a surfacefinish consistent with end-use application.6.3 The sample shall be sterilized by the method to be usedfor