ASTM_F_2901_-_19.pdf

Designation:F290119Standard 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 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 adverse 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 contactcentral and/or peripheral nervous system tissue or cerebralspinal fluid(CSF).NOTE1The results of these in vitro and in vivo tests may notcorrespond to actual human response.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,health,and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.3 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:2F748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF756 Practice for Assessment of Hemolytic Properties ofMaterialsF1904 Practice for Testing the Biological Responses toParticles in vivo2.2 Other Referenced Documents:ISO 10993-1 Biological Evaluation of Medical DevicesPart 1:Evaluation and Testing Within a Risk ManagementProcessISO 10993-3 Biological Evaluation of Medical DevicesPart 3:Tests for Genotoxicity,Carcinogenicity,and Re-productive Toxicity3ISO 10993-5 Biological Evaluation of Medical DevicesPart 5:Tests for In Vitro Cytotoxicity3ISO 10993-6 Biological Evaluation of Medical DevicesPart 6:Tests for Local Effects After ImplantationISO 1099311 Biological Evaluation of Medical DevicesPart 11:Tests for Systemic ToxicityISO 10993-18 Biological Evaluation of Medical DevicesPart 18:Chemical Characterization of Materials3ANSI/AAMI ST72 Bacterial EndotoxinsTestMethodologies,Routine Monitoring,and Alternatives toBatch Testing3USP Rabbit Pyrogen Test4USP 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 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 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.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 March 1,2019.Published March 2019.Originallyapproved in 2012.Last previous edition approved in 2013 as F2901 13.DOI:10.1520/F290119.2For 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 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.1 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 testing recommendations should be considered fornew materials,established materials with different manufactur-ing methods t