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  • ASTM
    F1828-97(2014) Standard Specification for Ureteral Stents
    Edition: 2014
    $144.00
    Unlimited Users per year

Description of ASTM-F1828 2014

ASTM F1828-97-Reapproved2014

Historical Standard: Standard Specification for Ureteral Stents




ASTM F1828

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.


Keywords

indwelling devices; polymers; test methods; ureteral stents; urology;


ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)


DOI: 10.1520/F1828-97R14



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