1、Designation:F291412(Reapproved 2018)Standard 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
2、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 addresses the determination of appropriatedevice attributes for testing as part of a shelf-life study fo
3、rendovascular devices.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
4、 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.1.4 This international standar
5、d 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.Terminol
6、ogy2.1 Definitions:2.1.1 endovascular devicedevice 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 to
7、remain in storage at specified conditions and maintain 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 Esta
8、blishment Model IntroductionThe deci-sion flow chart(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 p
9、articular attribute during aging.The risk to thepatient 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 cha
10、nge overtime?”:4.2.1 Considerations in Evaluating Question 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 Propert
11、ies/CharacterizationComposition;Mechanical Properties;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
12、toconfirm that some specific attributes do not change 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 c
13、ertain attri-butes may not require shelf-life testing,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 e
14、xample,steril-ization)may change the physical or chemical attribute(s)of thematerial.Finally consider whether there are interactions(chemical or physical)that may impact your assessment.1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is th
15、e direct responsibility of SubcommitteeF04.30 on Cardiovascular Standards.Current edition approved Nov.1,2018.Published November 2018.Originallyapproved in 2012.Last previous edition approved in 2012 as F291412.DOI:10.1520/F291412R18.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,Wes
16、t 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 FIG.1 Device Aging Shelf-life Establishment Flow ChartF2914 12(2018)2 4.2.1.4 In order for testing to be applicable,the testing mustbe conduct