1、Designation:F291412Standard Guide forIdentification of Shelf-life Test Attributes for EndovascularDevices1This standard is issued under the fixed designation F2914;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revi
2、sion.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 addresses the determination of appropriatedevice attributes for testing as part of a shelf-life study forendovascular dev
3、ices.Combination and biodegradable devices(for example drug-devices,biologic devices or drug biologics)may require additional considerations,depending on theirnature.1.2 This guide does not directly provide any test methodsfor conducting shelf-life testing.1.3 This standard does not purport to addre
4、ss 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.Terminology2.1 Definitions:2.1.1 endovascular devicedevice
5、used to treat vasculardisease from within the vessel.2.1.2 productfinal packaged and sterilized device with allincluded components.2.1.3 shelf lifethe amount of real time that a fully pack-aged(and sterilized,if applicable)product can be expected toremain in storage at specified conditions and maint
6、ain itscritical performance properties.3.Significance and Use3.1 The purpose of this guide is to provide a procedure fordetermining the appropriate attributes to evaluate in a shelf-lifestudy for an endovascular device.4.Procedure4.1 Shelf-life Establishment Model IntroductionThe deci-sion flow char
7、t(Fig.1)assists study developers in selectingand justifying risk-appropriate test protocols for medical de-vices to establish shelf life.The decision flowchart is intendedto elicit questions and an appropriate rationale for testing or nottesting a particular attribute during aging.The risk to thepat
8、ient as the device ages is one of the primary drivers.It isrecommended that all regulatory requirements and guidancesbe considered during development of the shelf-life establish-ment test plan.See Fig.1.4.2 Question 1:“Could the device attribute change overtime?”:4.2.1 Considerations in Evaluating Q
9、uestion 1This ques-tion must be addressed based on the device design character-istics(and also in relation to the device being packaged,sterilized,shipped and stored).4.2.1.1 Consider attributes such as the following,for ex-ample:(1)Material Properties/CharacterizationComposition;Mechanical Properti
10、es;Corrosion Resistance(2)Dimensional and Functional PropertiesDimensions;Surface Area;Foreshortening(3)Deliverability and FunctionalityBalloon Fatigue;Balloon Rated Burst;Bond Tensile Strength4.2.1.2 Various sources may provide sufficient evidence toconfirm that some specific attributes do not chan
11、ge over timefor the application or that the change is not a risk to the patient.(1)Scientific literature.(2)Appropriate vendor publication.(3)In-house research.(4)Assessment of clinically accepted device.4.2.1.3 When using such data to justify why certain attri-butes may not require shelf-life testi
12、ng,consider all differencesbetween the subject device and the source of those data toensure applicability.For example,vendor literature may notrepresent the actual use of the material by the device manu-facturer.Additionally,further processing(for example,steril-ization)may change the physical or ch
13、emical attribute(s)of thematerial.Finally consider whether there are interactions(chemical or physical)that may impact your assessment.4.2.1.4 In order for testing to be applicable,the testing mustbe conducted on articles that are representative of the finaldevice(that is,utilizing the same steriliz
14、ation method and dose,dimensions,material,processing conditions,and packaging).If1This 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 Jan.15
15、,2012.Published February 2012.DOI:10.1520/F291412.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 FIG.1 Device Aging Shelf-life Establishment Flow ChartF2914 122 test articles are not identical,provide appropriate justificationfor applica
16、bility of the testing.4.2.2 Justification Based upon Scientific PrinciplesWhenone considers whether an attribute should be included in ashelf-life study,the first question is whether the attributechanges over time.There are several device attributes that maybe driven by physical parameters of the device that would notchange over time and therefore will not require shelf-lifetesting.The assessment should be conducted using universalscientific/physical principles.In cases where the assessment isba
