ASTM F1828-97(2006)
(Specification)Standard Specification for Ureteral Stents
Standard Specification for Ureteral Stents
ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-12 molybdenum- 6 zirconium-2 iron alloy for surgical implants to be used in the manufacture of surgical implants. The heat analysis shall conform to the chemical composition requirements prescribed. Ingot analysis may be used for reporting all chemical requirements, except hydrogen. The wrought titanium-12 molybdenum-6 zirconium-2 iron alloy are classified as bar, forging bar and wire. The ultimate tensile strength, yield strength, elongation, and area reduction of the material shall be tested to meet the requirements prescribed.This specification covers the referee test methods for evaluating the performance characteristics of a single-use ureteral stent with retaining means at both ends, during short term use for drainage of urine from the kidney to the bladder. Ureteral stents shall be tested in accordance with the appropriate biological tests to meet the requirements prescribed. Retention strength, break strength, elongation, dynamic frictional force, and radiopacity shall be tested to meet the requirements prescribed.
SCOPE
1.1 This specification covers the referee test methods for evaluating the performance characteristics of a single-use ureteral stent with retaining means at both ends, during short term use for drainage of urine from the kidney to the bladder. These stents are typically available in diameters of 3.7 Fr to 14.0 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 Exclusions—Long-term indwelling usage (over 30 days) is encountered with this product, but not commonly, and is therefore considered an exception to this specification. Similarly, the use of ureteral stents for non-ureteral applications such as nephrostomy and ileostomy is excluded from the scope of this specification. Non-sterile ureteral stents are also excluded due to the variability of hospital sterilization equipment and processes and the resulting effects on ureteral stent characteristics.
1.3 The following precautionary statement pertains only to the test method portion, Section 5, of this specification:
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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Designation:F1828 −97(Reapproved 2006)
Standard Specification for
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Ureteral Stents
This standard is issued under the fixed designation F1828; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
The objective of this specification is to describe the test methods used to evaluate the safety and
effectiveness 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 performance
characteristics of ureteral stents. Note that the test methods are not to be construed as production
methods, quality control techniques, or manufacturer’s lot release criteria. The product parameters
addressed by the standard include those determined by the ASTM task group to be pertinent to the
product.
1. Scope 2. Referenced Documents
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1.1 This specification covers the referee test methods for 2.1 ASTM Standards:
evaluating the performance characteristics of a single-use D412 Test Methods forVulcanized Rubber andThermoplas-
ureteral stent with retaining means at both ends, during short tic Elastomers—Tension
term use for drainage of urine from the kidney to the bladder. F640 Test Methods for Determining Radiopacity for Medi-
These stents are typically available in diameters of 3.7 Fr to cal Use
14.0Fr,andlengthsof8cmto30cm,andaremadeofsilicone, F748 PracticeforSelectingGenericBiologicalTestMethods
polyurethane, and other polymers. They are provided non- for Materials and Devices
sterile for sterilization and sterile for single-use.
3. Terminology
1.2 Exclusions—Long-termindwellingusage(over30days)
3.1 Definitions of Terms Specific to This Standard:
is encountered with this product, but not commonly, and is
3.1.1 artificial urine—a solution of organic and inorganic
therefore considered an exception to this specification.
compounds that closely simulates the chemical and physical
Similarly, the use of ureteral stents for non-ureteral applica-
properties of normal human urine.Artificial urine will be used
tions such as nephrostomy and ileostomy is excluded from the
asasubstituteforhumanurinetosimulatetheeffectsofhuman
scope of this specification. Non-sterile ureteral stents are also
urine on ureteral stents.
excluded due to the variability of hospital sterilization equip-
ment and processes and the resulting effects on ureteral stent 3.1.2 bladder retention means—physical feature of bladder
end of stent the prevents movement of stent out of bladder.
characteristics.
3.1.3 break strength—peak tensile load required to break
1.3 The following precautionary statement pertains only to
stent.
the test method portion, Section 5, of this specification:
3.1.4 cross section—view of stent tube when cut in a plane
1.4 This standard does not purport to address all of the
perpendicular to length of stent.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
3.1.5 distal—situated away from the point of origin. The
priate safety and health practices and determine the applica-
distal end of a stent is the end that resides in the bladder, also
bility of regulatory limitations prior to use.
known as the bladder end.
3.1.6 drainage holes—holes in wall of stent tubing that
allow flow of urine into and out of lumen of stent.
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This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
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Subcommittee F04.34 on Urological Materials and Devices. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved March 1, 2006. Published April 2006. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 1997. Last previous edition approved in 1997 as F1828 – 97. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F1828-97R06. the ASTM website.
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F1828−97 (2006)
3.1.7 dynamic frictional force—resistancetorelativemotion The manufacturer need not use this referee test method for
between two surfaces during motion. This force is defined as inspection and quality control.
the coefficient of kinetic friction multiplied by the force acting
3.1.16 retention strength—force required to overcome the
on the surface of the material in a plane perpendi
...
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