ASTM F2901-2013 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 13Standard 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 Methodsfor Materials and DevicesF1904 Practice for Testing the Biological Responses toParticles in vivo2.2 Other Referenced Documents:ISO/AAMI/ANSI 10993-3 :2003 Biological Evaluation o

6、fMedical DevicesPart 3: Tests for Genotoxicity,Carcinogenicity, and Reproductive Toxicity3ISO/AAMI/ANSI 10993-5 :2009 Biological Evaluation ofMedical DevicesPart 5: Tests for In Vitro Cytotoxicity3ISO 1099311 : 2006 Biological Evaluation of MedicalDevicesPart 11: Tests for Systemic ToxicityISO/AAMI/

7、ANSI 10993-18 Biological Evaluation of Medi-cal DevicesPart 18: Chemical Characterization of Ma-terials3ANSI/AAMI ST72 :2010 Bacterial EndotoxinsTestMethodologies, Routine Monitoring, and Alternatives toBatch Testing3USP Rabbit Pyrogen Test4USP Transfusion and Infusion Assemblies and Simi-lar Medica

8、l Devices43. Summary of Guide3.1 This is an informative guide and should be used withPractice F748.3.2 The duration of contact between the tissue and medicaldevice should be considered when determining the appropriatepanel of testing. This guide may not address neurosurgicalinstruments or medical de

9、vices that have transient incidentalcontact with the nervous system due to the limited tissuecontact duration.3.3 The evaluation of neurotoxicity should be considered inconjunction with material characterization and other informa-tion such as non-clinical tests, clinical studies, post-marketexperien

10、ce, and intended use.4. Significance and Use4.1 The objective of this guide is to recommend a panel ofbiological tests 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 t

11、esting recommendations should be considered fornew materials, established materials with different manufactur-ing methods 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 wit

12、h a history of clinical use in a similarnervous tissue application.1This guide is under the 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 Feb. 1, 2013. P

13、ublished February 2013. Originallyapproved in 2012. Last previous edition approved in 2012 as F2901 12. DOI:10.1520/F290113.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, r

14、efer 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, http:/www.ansi.org.4Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,MD 20852-1790, http:/www.usp.org.Cop

15、yright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States15. Tests for Neurotoxicity5.1 Testing should be performed on the final sterilizeddevice, representative samples from the final sterilized device,or materials processed in the same manner as

16、 the final sterilizeddevice. Testing of individual materials may be useful forresearch and development, but the definitive neurotoxicityevaluation should include all materials in the final version ofthe device. The test article should be exposed to all phases ofmanufacturing including processing, cl

17、eaning, 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, purity, and toxicityprofile. Chemical characterization studies can provide addi-tional information on the de

18、vice 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 within the scope of this guide.5.2.1 CytotoxicityCytotoxicity assays are sensitivescreening tools that gener

19、ally serve as a starting point forevaluating medical device biocompatibility. See X1.4 forinformation on neuro-cytotoxicity testing.5.2.2 GenotoxicityNervous tissue contains proliferatingcell populations, and can respond to device implantation witha proliferative response. Nervous tissue is also kno

20、wn to giverise to various tumor types. To ensure that medical devices donot include genotoxic chemicals, the use of a panel ofgenotoxicity tests is recommended. The panel of genotoxicitytests should include a test for gene mutation in bacteria, anin-vitro test with cytogenetic evaluation of chromoso

21、mal dam-age with mammalian cells or an in-vitro mouse lymphoma tkassay, and an in-vivo test for chromosomal damage usingrodent hematopoietic cells. See ISO/AAMI/ANSI 10993-3 foradditional information on genotoxicity testing.5.2.3 ImplantationThe use of a clinically relevant implan-tation study is re

22、commended. The implantation site and 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; m

23、yelinopathy;neurodegeneration; neurotoxicity5The boldface numbers in parentheses refer to the list of references at the end ofthis standard.F2901 132APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 The primary purpose of this guide is to describe a testbattery capable of detecting medical device-

24、mediated neuro-toxicity.X1.2 It is well 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

25、 system has limitedcapacity for repair, increasing the importance of preclinicaldetection of potential neurotoxicants used in medical devices.X1.3 This guide considered the Food and Drug Administra-tion Center for Food Safety and Nutrition Document entitledToxicological Principles for the Safety Ass

26、essment of FoodIngredients: IV.C.10 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,specificity, and predictivity of neuro-c

27、ytotoxicity testing arenot well established. In addition, as with traditional cytotoxic-ity testing, neuro-cytotoxicity testing can yield false negativeand false positive results. Despite these potential limitations,evaluation of potential medical device neurotoxicity may beimproved by the use of ce

28、ll lines derived from nervous tissuesince these cells are more likely to express nervous tissue-specific toxicant targets. Therefore, consideration should begiven to the inclusion of a neuro-cytotoxicity test in addition totraditional cytotoxicity testing. For additional information onin vitro techn

29、iques for the assessment of neurotoxicity includ-ing cell line recommendations, see Harry et al. (8).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., Sto

30、wers, C. 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 andrelated glial proteins as biomarkers of neurotoxicity,. Ex

31、pert OpinDrug 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 de

32、velopmental neurotox-icity test: a report from the ILSI Research Foundation/Risk ScienceInstitute expert working group on neurodevelopmental endpoints,Neurotoxicol Teratol, Vol 30, No. 4, 2008, pp. 288325.(6) U.S. Food and Drug Administration Redbook: Toxicological Prin-ciples for the Safety Assessm

33、ent of Food Ingredients, NeurotoxicityStudies, 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,

34、D., Smith, R.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.

35、Users of this 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 ev

36、ery five years 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 tech

37、nical committee, 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 Conshohoc

38、ken, PA 19428-2959,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 133