ASTM F2081-2006(2017) Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents《血管支架尺寸特性描述和表示的标准指南》.pdf

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1、Designation: F2081 06 (Reapproved 2017)Standard Guide forCharacterization and Presentation of the DimensionalAttributes of Vascular Stents1This standard is issued under the fixed designation F2081; the number immediately following the designation indicates the year oforiginal adoption or, in the cas

2、e 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 covers the identification of and recom-mended measurement methods for those dime

3、nsional attributesof vascular stents that are deemed relevant to successfulclinical performance. The delivery system packaged with andlabeled specifically for use during the placement of the stent isalso included within the scope of this guide.1.2 This guide addresses only the dimensional characteri

4、s-tics of stents. Material property and stent functional character-istics are not addressed herein. All dimensional characteristicsdescribed in this guide refer to in vitro (“bench-top”) charac-terization. Because of variable patient factors, for example,vessel compliance, the actual in vivo charact

5、eristics may beslightly different.1.3 This guide includes recommendations generally appli-cable to balloon-expandable and self-expanding stents fabri-cated from metals and metal alloys. It does not specificallyaddress any attributes unique to coated stents or polymeric orbiodegradable stents, althou

6、gh the application of this guide tothose products is not precluded.1.4 While they are not specifically included within the scopeof this guide, stents indicated for placement in nonvascularlocations, such as the esophagus or bile duct, also might becharacterized by the methods contained herein. Likew

7、ise, thisguide does not include recommendations for endovasculargrafts (“stent-grafts”) or other conduit devices commonly usedto treat aneurysmal disease or peripheral vessel trauma or toprovide vascular access, although some information includedherein may be applicable to those devices.1.5 This gui

8、de does not include recommendations for bal-loon catheters sold as stand-alone angioplasty catheters, eventhough some of those catheters may be used for the delivery ofunmounted stents supplied without a delivery system. Require-ments for angioplasty catheters are contained in standards ISO10555-1 a

9、nd ISO 10555-4.1.6 The values stated in either SI units or inch-pound unitsare to be regarded separately as standard. The values stated ineach system may not be exact equivalents; therefore, eachsystem shall be used independently of the other. Combiningvalues from the two systems may result in non-c

10、onformancewith the standard.1.6.1 The units of measurements used throughout this guidereflect the hybrid system in common clinical use in the UnitedStates as of the time of the original approval of this guide.Since a primary purpose of this guide is to promote uniformityof labeling to facilitate the

11、 selection of devices by clinicalusers, the units most preferred by users were selected for thisguide. Where those units are not SI units, or derivativesthereof, SI units are provided in parentheses.1.7 This international standard was developed in accor-dance with internationally recognized principl

12、es 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 ISO Standards:ISO 10555-1, Sterile, Single-Use Intr

13、avascular Catheters,General Requirements2ISO 10555-4, Sterile, Single-Use Intravascular CathetersBalloon Dilation Catheters23. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 balloon-expandable stent, na stent that is expandedat the treatment site by a balloon catheter. The stent

14、 is alteredpermanently by the balloon expansion such that the stentremains expanded after deflation of the balloon.3.1.2 bridge, na connecting element between the radialsupport aspects of a stent. A bridge may have unique designfeatures, as compared to a strut, to enhance longitudinalflexibility and

15、 minimize shortening.1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devicesand is the direct responsibility of SubcommitteeF04.30 on Cardiovascular Standards.Current edition approved Sept. 1, 2017. Published September 2017. Originallyapproved in 2001

16、. Last previous edition approved in 2013 as F2081 06 (2013).DOI: 10.1520/F2081-06R17.2Available 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

17、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 Te

18、chnical Barriers to Trade (TBT) Committee.13.1.3 crimp, vto secure the stent on the delivery system bycompressing the stent onto the balloon. Stents sold unmountedmust be crimped manually by the clinical staff before use.3.1.4 crossing profile, na linear measure of the maximumbreadth of the stent/de

19、livery system over the distal-most regionof the delivery system.3.1.5 delivery system, na system that is used to deliver anddeploy a stent at the target site. A delivery system may besimilar to a balloon dilatation catheter; a delivery system for aself-expanding stent might not have a balloon.3.1.6

20、diameter, nrefers to the inside diameter (ID) of thestent unless otherwise noted.3.1.7 diameter, labeled, nsingle value representation ofintended-use diameters, typically rounded to nearest 0.25 or0.5 mm. The labeled diameter is within the range recom-mended in the Instructions for Use (IFU) for tha

21、t particularstent and delivery system.3.1.8 percent solid area, nthat percentage of the projectedcylindrical side surface area ( times outside diameter timeslength at labeled diameter) that is covered by stent material,when the stent is expanded to its labeled diameter.3.1.9 premounted stent, na ste

22、nt supplied by a manufac-turer already mounted on a delivery system.3.1.10 self-expanding stent, na stent that expands withoutextrinsic force or pressure, to a size and shape close to thedesired final size and shape, when released from the deliverysystem. The self-expanding nature of some stents is

23、a designfeature resulting from the materials of construction or thestructural geometry, or both.3.1.11 sheath, na movable cover that constrains a self-expanding stent on the delivery system until its desired releaseor protects a balloon-expandable stent during delivery beforedeployment.3.1.12 shorte

24、ning/lengthening, nthe percentage change inlength between the undeployed mounted condition and theexpanded labeled-diameter condition.3.1.13 stent, vascular, na synthetic tubular structure that ispermanently implanted in the native or grafted vasculature andthat is intended to provide mechanical rad

25、ial support toenhance vessel patency. For the purposes of this guide, a stentis metallic and not covered by synthetic textile or tissue graftmaterial.3.1.14 strut, nthe smallest individual element of the radialsupport aspect of a stent that has a solid cross section in boththe radial and circumferen

26、tial directions.3.1.15 unmounted stent, na stent that is not crimped on adelivery system as supplied by the manufacturer. Before use,the clinical staff must manually crimp unmounted stents onto adelivery device.4. Significance and Use4.1 Vascular stents are intended for permanent implant inthe human

27、 vasculature (native or graft) for the purposes ofmaintaining vessel patency. The dimensional attributes ofvascular stents are critical parameters that aid clinicians in theselection of devices for individual patients. This guide containsa listing of those dimensional attributes that are directly re

28、latedto the clinical utility and performance of these devices, alongwith recommendations for consistent methods of measuringthese attributes and presenting the information for use inclinical decision making. This guide can be used by themanufacturers and researchers of stents to provide consistencyo

29、f measurement and labeling of these dimensional character-istics. It may have use in the regulation of these devices byappropriate authorities.4.2 The dimensional attributes included in this guide arethose that are deemed related to or possibly predictive ofsuccessful clinical performance of the ste

30、nt, based on priorclinical experience; however, because of the myriad patient andmedical factors that influence the clinical outcome of anyindividual treatment, conformance of a stent and deliverysystem with the recommendations in this guide should not beinterpreted as a guarantee of clinical succes

31、s in any individualpatient or group of patients.5. Classification5.1 Stents may be classified by the following characteristics,as defined in Section 3.5.1.1 MountingPremounted or unmounted.5.1.2 ExpansionBalloon expandable or self-expanding.6. Test Devices and General Procedures6.1 Unless otherwise

32、justified, all samples selected fortesting or measuring the attributes described in this guideshould be taken from finished, clinical-quality product. Cos-metic rejects or other nonclinical samples may be used if thecause for rejection is not related to the attribute being assessed.Sterilization can

33、 be omitted if it can be demonstrated thatsterilization has no affect on the attribute being assessed.6.2 When specimen preparation (for example, manualcrimping onto a delivery system, balloon expansion), is re-quired before testing, this should be done in accordance withthe Instructions for Use (IF

34、U).6.3 The preconditioning and test environments must beappropriately selected for each design and attribute. Tempera-ture and fluid immersion may have a significant effect on someattributes but a negligible affect on others. For example, fluidsorption may swell catheters and affect the measurement

35、ofcrossing profile. Temperature may affect the final deployeddiameter for stents made from shape memory materials. Formeasurements for which deployment, or measurement, or both,is to be made in a controlled environment, the stent or deliverysystem, or both, should be immersed in a water bath main-ta

36、ined at 37 6 2C and allowed to equilibrate.6.4 The number of specimens evaluated for each diameterfor each stent design should be sufficient to meet the samplingrequirements for the desired labeling. In general, a minimum often replicate test devices of each size to be measured or testedis recommend

37、ed. If a single stent design is intended to bedeployed over a broad range of diameters by use on differentsize delivery systems, the dimensional attributes should beevaluated for each stent/delivery system combination.F2081 06 (2017)27. Dimensions and Measurement Methods7.1 Deployed DiameterUnless o

38、therwise specified, alldeployed diameters refer to the inside diameter, reported inmillimetres to the nearest 0.1 mm, after balloon deflation (forballoon-expandable stents).7.1.1 MeasurementThe outside diameter of deployedstents should be measured by noncontacting instruments (pro-file projector, la

39、ser micrometer, and so forth) with a resolutionof 0.05 mm or better. Inside diameter can then be calculated bysubtracting twice the wall thickness (7.4). Alternatively, theinside diameter can be measured by calibrated gauges.7.1.2 Labeled DiameterThe labeled diameter is that usedto identify the typi

40、cal deployed size of a particular device, forexample, 3.0 mm or 3.5 mm, and must be clearly identified asinside or outside diameter (ID or OD). ID is preferred. Thelabeled diameter is usually rounded to the nearest 0.25 or 0.5mm.7.1.3 Stent System ComplianceFor balloon-expandablestents, a table or g

41、raph of inflation pressure versus expandeddiameter should be developed and included in the labeling. Aminimum of ten replicate devices should be measured at eachstent size at each labeled inflation pressure. The expanded stentinside diameter at each inflation pressure, rounded to thenearest 0.05 mm,

42、 should be the mean of all measurementstaken on all stents at that pressure. The inflation pressureshould be expressed in atmospheres. This attribute does notapply to self-expanding stents.7.1.4 Uniformity of ExpansionThe uniformity of expan-sion refers to the difference between the largest and smal

43、lestdiameter measurement on a single stent deployed to its labeleddiameter. Uniformity of expansion is not intended to charac-terize deliberate deviations from cylindricity, such as taperedconstruction, end flares, antimigration barbs, and so forth.Measurements for the uniformity of expansion should

44、 be takenat three axial locations (mid-length and close to each end) ateach of two circumferential orientations at about 90 separa-tion. The uniformity of expansion reflects both the deviationfrom circularity of the stent cross section and unintendeddifferences in diameter along the stent length.7.2

45、 Stent Length:7.2.1 MeasurementThe length of mounted or expandedstents should be measured by noncontacting instruments (pro-file projection, laser micrometer, and so forth) with a resolutionof 0.1 mm or better. Measurements should be taken on eachstent in the mounted state and at the labeled diamete

46、r. Lengthsshould reflect measurements on a minimum of ten replicatedevices and should be reported to the nearest 1 mm.7.2.2 Labeled Expanded LengthThe labeled expandedlength is that used to identify the typical size of a particulardevice, for example, 20 mm. The labeled expanded length isusually rou

47、nded to the nearest 1 mm.7.2.3 Mounted (Undeployed) LengthThis attribute has nosignificance in and of itself. It provides a baseline for thedetermination of shortening/lengthening. Direct measurementof the mounted length may not be possible for sheathedsystems. Other appropriate methods may be used.

48、7.2.4 Shortening/LengtheningRefers to the percentagechange in length between the undeployed mounted conditionand the expanded labeled-diameter condition. Shortening/lengthening should be reported as a percentage of the mounted(undeployed) length to the nearest 1 %.7.3 Crossing Profile:7.3.1 Measurem

49、entWith the stent premounted or hand-crimped on the delivery system in accordance with the instruc-tions for use, and the sheath (if any) in place, measure themaximum diameter over the length from the proximal end ofthe mounted stent to the distal tip of the delivery system. Aminimum of ten replicate test articles should be measured. Themeasurement instrument should be either noncontacting (opti-cal profilometer, laser micrometer, and so forth) or a ring/holegage, and should have a resolution of 0.001 in. 0.025 mm orbetter. The crossing profile should