ASTM_F_1828_-_97_2014.pdf

Designation:F182897(Reapproved 2014)Standard Specification forUreteral Stents1This standard is issued under the fixed designation F1828;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.INTRODUCTIONThe objective of this specification is to describe the test methods used to evaluate the safety andeffectiveness of an indwelling ureteral stent,having retention means at the kidney and bladder ends,used for urinary drainage of the kidney to the bladder via the ureter.This specification includes referee test methods that can be used to evaluate the performancecharacteristics of ureteral stents.Note that the test methods are not to be construed as productionmethods,quality control techniques,or manufacturers lot release criteria.The product parametersaddressed by the standard include those determined by the ASTM task group to be pertinent to theproduct.1.Scope1.1 This specification covers the referee test methods forevaluating the performance characteristics of a single-useureteral stent with retaining means at both ends,during shortterm use for drainage of urine from the kidney to the bladder.These stents are typically available in diameters of 3.7 Fr to14.0 Fr,and lengths of 8 cm to 30 cm,and are made of silicone,polyurethane,and other polymers.They are provided non-sterile for sterilization and sterile for single-use.1.2 ExclusionsLong-term indwelling usage(over 30 days)is encountered with this product,but not commonly,and istherefore considered an exception to this specification.Similarly,the use of ureteral stents for non-ureteral applica-tions such as nephrostomy and ileostomy is excluded from thescope of this specification.Non-sterile ureteral stents are alsoexcluded due to the variability of hospital sterilization equip-ment and processes and the resulting effects on ureteral stentcharacteristics.1.3 The following precautionary statement pertains only tothe test method portion,Section 5,of this specification:1.4 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:2D412 Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionF640 Test Methods for Determining Radiopacity for Medi-cal UseF748 Practice for Selecting Generic Biological Test Methodsfor Materials and Devices3.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 artificial urinea solution of organic and inorganiccompounds that closely simulates the chemical and physicalproperties of normal human urine.Artificial urine will be usedas a substitute for human urine to simulate the effects of humanurine on ureteral stents.3.1.2 bladder retention meansphysical feature of bladderend of stent the prevents movement of stent out of bladder.3.1.3 break strengthpeak tensile load required to breakstent.3.1.4 cross sectionview of stent tube when cut in a planeperpendicular to length of stent.3.1.5 distalsituated away from the point of origin.Thedistal end of a stent is the end that resides in the bladder,alsoknown as the bladder end.3.1.6 drainage holesholes in wall of stent tubing thatallow flow of urine into and out of lumen of stent.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.34 on Urological Materials and Devices.Current edition approved Oct.1,2014.Published November 2014.Originallyapproved in 1997.Last previous edition approved in 2006 as F1828 97(2006).DOI:10.1520/F1828-97R14.2For 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.7 dynamic frictional forceresistance to relative motionbetween two surfaces during motion.This force is defined asthe coefficient of kinetic friction multiplied by the force actingon the surface of the material in a plane perpendicular to thesurface.3.1.8 elongationexpressed as a percent,is equal to thechange in length of a sample of tubing at failure divided by itsoriginal length.Stretching of the tubing is produced by tensileloading.3.1.9 French sizeScale used to indicate size of tubulardevices,each unit being approximately equal to 0.013 in.or0.33 mm in diameter.Typical label French sizes are as follows:French SizeOutside Diameterin.mm3.70.050,1.234.50.060,1.504.70.061,1.576.00.079,2.007.00.