ASTM_F_3172_-_15.pdf

Designation:F317215Standard Guide forDesign Verification Device Size and Sample Size Selectionfor Endovascular Devices1This standard is issued under the fixed designation F3172;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 This guide provides guidance for selecting an appropri-ate device size(s)and determining an appropriate samplesize(s)(that is,number of samples)for design verificationtesting of endovascular devices.Amethodology is presented todetermine which device size(s)should be selected for testing toverify the device design adequately for each design inputrequirement(that is,test characteristic).Additionally,differentstatistical approaches are presented and discussed to help guidethe developer to determine and justify sample size(s)for thedesign input requirement being verified.Alternate methodolo-gies for determining device size selection and sample sizeselection may be acceptable for design verification.1.2 This guide applies to physical design verification test-ing.This guide addresses in-vitro testing;in-vivo/animal stud-ies are outside the scope of this guide.This guide does notdirectly address design validation;however,the methodologiespresented may be applicable to in-vitro design validationtesting.Guidance for sampling related to computational simu-lation(for example,sensitivity analysis and tolerance analysis)is not provided.Guidance for using models,such as design ofexperiments(DOE),for design verification testing is notprovided.This guide does not address sampling across multiplemanufacturing lots as this is typically done as process valida-tion.Special considerations are to be given to certain tests suchas fatigue(see Practice E739)and shelf life testing(see Section8).1.3 Regulatory guidance may exist for endovascular devicesthat should be considered for design verification device sizeand sample size selection.1.4 UnitsThe values stated in SI units are to be regardedas the standard.No other units of measurement are included inthis standard.1.5 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 use.2.Referenced Documents2.1 ASTM Standards:2E739 Practice for StatisticalAnalysis of Linear or LinearizedStress-Life(S-N)and Strain-Life(-N)Fatigue DataF2914 Guide for Identification of Shelf-life Test Attributesfor Endovascular Devices2.2 ISO Standards:3ISO 14971:2012 Medical devicesApplication of risk man-agement to medical devices3.Terminology3.1 Definitions:3.1.1 attribute data,ndata that identify the presence orabsence of a characteristic(for example,good/bad or pass/fail).3.1.2 design input requirements,nphysical and perfor-mance requirements of a device that are used as a basis fordevice design(typically defined as test characteristics such asballoon burst pressure,shaft tensile strength,and so forth).3.1.3 design output,nfeatures of the device(that is,dimensions,materials,and so forth)that define the design andmake it capable of achieving design input requirements.3.1.4 design subgroup,nset defined by the device sizeswithin the device matrix in which the essential design outputsdo not vary for a specified design input requirement(that is,device sizes that share the same design for a specified designinput requirement).3.1.5 design validation,nestablishing by objective evi-dence that the device conforms to defined user needs andintended use(s).1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.30 on Cardiovascular Standards.Current edition approved Dec.15,2015.Published February 2016.DOI:10.1520/F317215.2For 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.6 design verification,nconfirmation by examinationand provision of objective evidence that the device design(design output)fulfills the specified requirements(designinput).3.1.7 device matrix,nentire range of available models/sizes for the device family.3.1.8 device size,nindividual model/size(for example,6mm diameter by 25 mm length balloon on 135 cm lengthcatheter or a 6Fr 100 cm length guide catheter).3.1.9 endovascular device,ndevice used to treat vasc