1、Designation:F290113Standard 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 last rev
2、ision.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 adverse effects
3、 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 tissue or cerebra
4、l 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 limitations prior to us
5、e.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 ofMedical DevicesPart
6、 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/ANSI 10993-18 Biological Ev
7、aluation 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 Medical Devices43.Summary of Guide3.1
8、 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 devices that have transient inciden
9、talcontact 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-marketexperience,and intended use.4.Significance
10、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 testing recommendations should be consi
11、dered 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 with a history of clinical use in a similar
12、nervous 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.Published February 2013.Originallyapproved i
13、n 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,refer to the standards Document Summary page onthe A
14、STM 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,We
15、st Conshohocken,PA 19428-2959.United States1 5.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 the final sterilizeddevice.Testing of individual materials may be u
16、seful 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,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,purity,and toxicityprofile.Chemical characterization studies can provide addi-tion
