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ASTM-F1828:2006 Edition

ASTM-F1828:2006 Edition

$40.63

F1828-97(2006) Standard Specification for Ureteral Stents

Published By Publication Date Number of Pages
ASTM 2006 6
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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.

PDF Catalog

PDF Pages PDF Title
1 Scope
Referenced Documents
Terminology
2 Requirements
Special Precautions
Test Methods
FIG. 1
3 FIG. 2
4 FIG. 3
5 Report
Keywords
6 A1. ARTIFICIAL URINE FORMULATIONS
A1.1 Formulation Number 1
A1.2 Formulation Number 24
X1. RATIONALE
X1.1
X1.2

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