ASTM F2901-2012 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices《评估医疗设备潜在神经毒性的选择试验的标准指南》.pdf

1、Designation: F2901 12Standard Guide forSelecting Tests to Evaluate Potential Neurotoxicity ofMedical Devices1This standard is issued under the fixed designation F2901; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of las

2、t revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 Medical devices may cause adverse effects on thestructure and/or function of the nervous system. In this guide,these adve

3、rse effects are defined as neurotoxicity. This guideprovides background information and recommendations onmethods for neurotoxicity testing. This guide should be usedwith Practice F748, and may be helpful where neurotoxicitytesting is needed to evaluate medical devices that contactnervous system tis

4、sue or cerebral spinal fluid (CSF).1.2 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 limit

5、ations prior to use.2. Referenced Documents2.1 ASTM Standards:2F748 Practice for Selecting Generic Biological Test Meth-ods for Materials and DevicesF1904 Practice for Testing the Biological Responses toParticles in vivo2.2 Other Referenced Documents:ISO/AAMI/ANSI 10993-3 :2003Biological Evaluation

6、ofMedical DevicesPart 3: Tests for Genotoxicity, Carci-nogenicity, and Reproductive Toxicity3ISO/AAMI/ANSI 10993-5 :2009 Biological Evaluation ofMedical DevicesPart 5: Tests for In Vitro Cytotoxicity3ISO/AAMI/ANSI 10993-18 Biological Evaluation of Medi-cal DevicesPart 18: Chemical Characterization o

7、f Ma-terials3ANSI/AAMI ST72 :2010 Bacterial EndotoxinsTestMethodologies, Routine Monitoring, and Alternatives toBatch Testing3USP Transfusion and Infusion Assemblies and Simi-lar Medical Devices43. Summary of Guide3.1 This is an informative guide and should be used withPractice F748.3.2 The duration

8、 of contact between the tissue and medicaldevice should be considered when determining the appropriatepanel of testing. This guide may not address neurosurgicalinstruments or medical devices that have transient incidentalcontact with the nervous system due to the limited tissuecontact duration.3.3 T

9、he evaluation of neurotoxicity should be considered inconjunction with material characterization and other informa-tion such as non-clinical tests, clinical studies, post-marketexperience, and intended use.4. Significance and Use4.1 The objective of this guide is to recommend a panel ofbiological te

10、sts that can be used in addition to the testingrecommended in Practice F748. This guide is designed todetect neurotoxicity caused by medical devices that contactnervous tissue.4.2 The testing recommendations should be considered fornew materials, established materials with different manufactur-ing m

11、ethods that could affect nervous tissue response, ormaterials used in new nervous tissue applications.4.3 Chemical characterization can be used to evaluate simi-larity for materials with a history of clinical use in a similarnervous tissue application.5. Tests for Neurotoxicity5.1 Testing should be

12、performed on the final sterilizeddevice, representative samples from the final sterilized device,or materials processed in the same manner as the final sterilizeddevice. Testing of individual materials may be useful forresearch and development, but the definitive neurotoxicity1This guide is under th

13、e jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.16 on Biocompatibility Test Methods.Current edition approved Sept. 1, 2012. Published October 2012. DOI: 10.1520/F290112.2For referenced ASTM standards, visit the AST

14、M 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.3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036

15、, http:/www.ansi.org.4Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,MD 20852-1790, http:/www.usp.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.evaluation should include all materials in the final vers

16、ion ofthe device. The test article should be exposed to all phases ofmanufacturing including processing, cleaning, sterilization,and packaging.5.1.1 A complete description of all device materials andreagents used during manufacturing and processing should beprovided with information on the source, p

17、urity, and toxicityprofile. Chemical characterization studies can provide addi-tional information on the device safety profile. See ISO/AAMI/ANSI 10993-18 for information on chemical characterizationof materials.5.2 The following tests should be considered to assessneurotoxicity of medical devices w

18、ithin the scope of this guide.5.2.1 CytotoxicityCytotoxicity assays are sensitivescreening tools that generally serve as a starting point forevaluating medical device biocompatibility. See X1.4 forinformation on neuro-cytotoxicity testing.5.2.2 GenotoxicityNervous tissue contains proliferatingcell p

19、opulations, and can respond to device implantation witha proliferative response. Nervous tissue is also known to giverise to various tumor types. To ensure medical devices do notinclude genotoxic chemicals, the use of a panel of genotoxicitytests is recommended. The panel of genotoxicity tests shoul

20、dinclude a bacterial assay and mammalian assays capable ofdetecting both gene level and clastogenic mutations. SeeISO/AAMI/ANSI 10993-3 for additional information on geno-toxicity testing.5.2.3 ImplantationThe use of a clinically relevant implan-tation study is recommended. The implantation site and

21、 animalmodel should be selected and justified according to theintended clinical use of the medical device. The study shouldinclude both histopathology and neurobehavioral assessments.In addition to the use of hematoxylin and eosin (H biocompatibility; microglia; myelinopathy;neurodegeneration; neuro

22、toxicity5The boldface numbers in parentheses refer to the list of references at the end ofthis standard.F2901 122APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 The primary purpose of this guide is to describe a testbattery capable of detecting medical device-mediated neuro-toxicity.X1.2 It is w

23、ell recognized that the nervous system is aheterogenous tissue comprised of unique cell types, proteins,and biochemical pathways. The interaction of materials withnervous tissue may adversely affect the structure and/or func-tion of the nervous system. The nervous system has limitedcapacity for repa

24、ir, increasing the importance of preclinicaldetection of potential neurotoxicants used in medical devices.X1.3 This guide considered the Food and Drug Adminis-tration Center for Food Safety and Nutrition Document entitledToxicological Principles for the Safety Assessment of FoodIngredients: IV.C.10

25、Neurotoxicity Studies Redbook 2000 (6),and the Environmental Protection Agency document entitledHealth Effects Test Guidelines OPPTS 870.6200 NeurotoxicityScreening Battery (7).X1.4 Neuro-Cytotoxicity TestingThe sensitivity, specific-ity, and predictivity of neuro-cytotoxicity testing are not welles

26、tablished. In addition, as with traditional cytotoxicity testing,neuro-cytotoxicity testing can yield false negative and falsepositive results. Despite these potential limitations, evaluationof potential medical device neurotoxicity may be improved bythe use of cell lines derived from nervous tissue

27、 since thesecells are more likely to express nervous tissue-specific toxicanttargets. Therefore, consideration should be given to the inclu-sion of a neuro-cytotoxicity test in addition to traditionalcytotoxicity testing. For additional information on in vitrotechniques for the assessment of neuroto

28、xicity including cellline recommendations, see Harry et al. (8) and ISO/AAMI/ANSI 10993-5.REFERENCES(1) Polikov, V. S., Tresco, P. A., Reichert, W. M., Response of brain tissueto chronically implanted neural electrodes, J Neurosci Methods,Vol148, No. 1, 2005, pp. 118.(2) Schmued, L. C., Stowers, C.

29、C., Scallet, A. C., Xu, L., Fluoro-Jade Cresults in ultra high resolution and contrast labeling of degeneratingneurons, Brain Res, Vol 1035, No. 1, 2005, pp. 2431.(3) OCallaghan, J. P., Sriram, K., Glial fibrillary acidic protein and relatedglial proteins as biomarkers of neurotoxicity,. Expert Opin

30、 Drug Saf,Vol 4, No. 3, 2005, pp. 433442.(4) Cunningham, B. W., Basic scientific considerations in total discarthroplasty, Spine J, Vol 4, No. 6 Suppl, 2004, pp. 219S230S.(5) Raffaele, K. C., Fisher, J. E. Jr., Hancock, S., Hazelden, K., Sobrian, S.K., Determining normal variability in a development

31、al neurotoxicitytest: a report from the ILSI Research Foundation/Risk Science Instituteexpert working group on neurodevelopmental endpoints, Neurotoxi-col Teratol, Vol 30, No. 4, 2008, pp. 288325.(6) U.S. Food and DrugAdministration Redbook: Toxicological Principlesfor the Safety Assessment of Food

32、Ingredients, Neurotoxicity Studies,2000, Chapter IV.C.10.(7) U.S. Environmental Protection Agency, Health Effects Test, Guide-lines OPPTS 870.6200 Neurotoxicity Screening Battery.(8) Harry, J. G., Billingsley, M., Bruinink, A., Campbell, L. L., Classen,W., Dorman, D. C., Galli, C., Ray, D., Smith, R

33、. A., and Tilson, H. A.,In Vitro Techniques for the Assessment of Neurotoxicity, EnvironHealth Perspect, Vol 106, No. Suppl 1, 1998, pp. 131158.ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of t

34、his standard are expressly advised that determination of the validity of any such patent rights, and the riskof 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 y

35、ears andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical comm

36、ittee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19

37、428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/).F2901 123