ASTM F756-2000 Standard Practice for Assessment of Hemolytic Properties of Materials《材料的溶血特性评定的标准规程》.pdf

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1、Designation: F 756 00Standard Practice forAssessment of Hemolytic Properties of Materials1This standard is issued under the fixed designation F 756; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A numbe

2、r 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 ofhemolytic properties of materials used in the fabrication ofmedical devices that wil

3、l contact blood.1.2 This practice is intended to evaluate the acute in vitrohemolytic properties of materials intended for use in contactwith blood.1.3 This practice consists of a protocol for a hemolysis testunder static conditions with either an extract of the material ordirect contact of the mate

4、rial with blood.1.4 This practice is one of several developed for theassessment of the biocompatibility of materials. Practice F 748may provide guidance for the selection of appropriate methodsfor testing materials for a specific application.1.5 This standard does not purport to address all of thesa

5、fety 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 conve

6、nience 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 Mater

7、ials and Devices23. Terminology3.1 Definitions:3.1.1 plasma hemoglobinthe amount of hemoglobin inthe plasma.3.1.2 % hemolysisthe quotient of the free plasma hemo-globin (mg/ml) released as a result of contact with test materialor extract divided by the total hemoglobin (mg/ml) present inthe blood so

8、lution multiplied by 100. (This is synonymous withhemolytic index).3.1.3 comparative hemolysiscomparison of the hemolyticindex produced by a test material compared with that producedby a standard reference material such as polyethylene at thesame test conditions.3.1.4 direct contact testa test for t

9、he hemolytic propertyperformed with the test material in direct contact with theblood.3.1.5 extract testa test for the hemolytic property per-formed with an isotonic extract of the test material, asdescribed in F 619, in contact with the blood.3.1.6 hemolysisdestruction of erythrocytes resulting int

10、he liberation of hemoglobin into the plasma or suspensionmedium.3.1.7 negative controla material, such as a polyethylene,that produces little or no hemolysis (5 hemolyticIn addition, if the mean from the replicate test samples is lessthan 5 but one or more samples gave a hemolytic index ofgreater th

11、an 5, then the test should be repeated with double thenumber of test articles.11. Precision and Bias11.1 PrecisionThe precision of this test method is beingestablished. Although this method has been shown to haveintralaboratory repeatability, especially with regards to classi-fication of hemolytic r

12、esponse, interlaboratory variation is stillsignificant.11.2 BiasThe bias of this test method includes the quan-titative estimates of the uncertainties of the calibration of thetest equipment and the skill of the operators. At this time,statements of bias should be limited to the documentedperformanc

13、e of particular laboratories.12. Keywords12.1 biocompatibility; blood compatibility; direct contact;extract; hemoglobin; hemolysis testingAPPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 The presence of hemolytic material in contact withblood may produce increased levels of blood cell lysis andin

14、creased levels of plasma hemoglobin. This may induce toxiceffects or other effects which may stress the kidneys or otherorgans.X1.2 This practice is presented as a screening procedure forcomparing the hemolytic potential of a material with that of anegative control material which is generally acknow

15、ledged tobe appropriate for blood contact applications. Materials with ahemolytic potential above that of the specified negative controlmaterial, which is known to have excellent performance inblood contacting situations, should be carefully considered foruse since they may or may not be a potential

16、 cause of in vivohemolysis.X1.3 The procedure as presented is intended as a routinereproducible screening procedure. It is not to be represented asbeing the most sensitive nor the most specific procedure forassessing the hemolytic potential of all materials in all useapplications. The results obtain

17、ed with this procedure areintended to be used in conjunction with the results of other testsin assessing the blood compatibility of the test material.F 7564REFERENCES(1) International Committee for Standardization in Haematology. J Clin.Pathol, 1978, 31: 139-143, 1978.(2) Moore GL, Ledford ME, Meryd

18、ith A., A micromodification of theDrabkin hemoglobin assay for measuring plasma hemoglobin in therange of 5 to 2000 mg/dl. Biochem. Med. 1981; 26:167-173.(3) Malinauskas, RA., Plasma hemoglobin measurement techniques forthe in vitro evaluation of blood damage caused by medical devices.Artificial Org

19、ans 1997; 21:1255-1267.The American Society for Testing and Materials takes no position respecting the validity of any patent rights asserted in connectionwith any item mentioned in this standard. Users of this standard are expressly advised that determination of the validity of any suchpatent right

20、s, and the risk of 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 either for

21、revision of this standard or for additional standardsand should be addressed to ASTM Headquarters. Your comments will receive careful consideration at a meeting of the responsibletechnical committee, which you may attend. If you feel that your comments have not received a fair hearing you should mak

22、e yourviews known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the above address or at610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website (www.astm.org).F 7565