ASTM F1828-22

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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

• Status: Published
• Publication Date: 31-Oct-2022
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.34 - Urological Materials and Devices

Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation:F1828 −22
Standard Specification for
1
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 1.5 This international standard was developed in accor-
dance with internationally recognized principles on standard-
1.1 This specification covers the referee test methods for
ization established in the Decision on Principles for the
evaluating the performance characteristics of a single-use
Development of International Standards, Guides and Recom-
ureteral stent with retaining means at both ends, during
mendations issued by the World Trade Organization Technical
short-term use for drainage of urine from the kidney to the
Barriers to Trade (TBT) Committee.
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
2. Referenced Documents
silicone, polyurethane, and other polymers. They are provided
2
2.1 ASTM Standards:
non-sterile for sterilization and sterile for single use.
D412 Test Methods forVulcanized Rubber andThermoplas-
1.2 Exclusions—Long-termindwellingusage(over30days)
tic Elastomers—Tension
is encountered with this product, but not commonly, and is
F640 Test Methods for Determining Radiopacity for Medi-
therefore considered an exception to this specification.
cal Use
Similarly, the use of ureteral stents for non-ureteral applica-
F748 PracticeforSelectingGenericBiologicalTestMethods
tions such as nephrostomy and ileostomy is excluded from the
for Materials and Devices
scope of this specification. Non-sterile ureteral stents are also
excluded due to the variability of hospital sterilization equip-
3. Terminology
ment and processes and the resulting effects on ureteral stent
3.1 Definitions of Terms Specific to This Standard:
characteristics.
3.1.1 test media—(1) saline, an isotonic solution of pH 5.5
1.3 The following precautionary statement pertains only to
to 7.0; (2) human urine; or (3) artificial urine, a solution of
the test method portion, Section 5, of this specification: organic and inorganic compounds that closely simulates the
chemical and physical properties of normal human urine.
1.4 This standard does not purport to address all of the
Artificial urine may be used as a substitute for human urine to
safety concerns, if any, associated with its use. It is the
simulate the effects of human urine on ureteral stents.
responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
3.1.2 bladder retention means—physical feature of bladder
mine the applicability of regulatory limitations prior to use.
end of stent that prevents movement of stent out of bladder.
3.1.3 break strength—peak tensile load required to break
stent.
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
2
Subcommittee F04.34 on Urological Materials and Devices. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Nov. 1, 2022. Published November 2022. Originally contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
approved in 1997. Last previous edition approved in 2017 as F1828 – 17. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F1828-22. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F1828−22
3.1.4 cross section—view of stent tube when cut in a plane 3.1.14 radiopacity—property indicating ability of device to
perpendicular to length of
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F1828 − 17 F1828 − 22
Standard Specification for
1
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
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 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.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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.34 on Urological Materials and Devices.
Current edition approved March 1, 2017Nov. 1, 2022. Published April 2017November 2022. Originally approved in 1997. Last previous edition approved in 20142017
as F1828F1828 – 17. –97 (2014). DOI: 10.1520/F1828-17.10.1520/F1828-22.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F1828 − 22
2. Referenced Documents
2
2.1 ASTM Standards:
D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
F640 Test Methods for Determining Radiopacity for Medical Use
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 test media —media—((1)1) saline, an isotonic solution of pH 5.5 to 7.0; (2or ) human urine; or ((2)3 human urine, to be used
for tests of ) artificial urine, a solution of organic and inorganic compounds that closely simulates the chemical and physical
properties of normal human urine. Artificial urine may be used as a substitute for human urine to simulate the effects of human
urine on ureteral stents.
3.1.2 bladder retention means—physical feature of bladder end of stent thethat prevents movement of stent out of bladder.
3.1.3 break strength—peak tensile load required to break stent.
3.1.4 cross section—view of stent tube when cut in a plane perpendicular to length of stent.
3.1.5 distal
...