ASTM F1828 - 17 - Standard Specification for Ureteral Stents

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ASTM F1828 - 17

Standard Specification for Ureteral Stents

Status : Current   Published : March 2017

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PDF

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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.

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.




Standard NumberASTM F1828 - 17
TitleStandard Specification for Ureteral Stents
StatusCurrent
Publication Date01 March 2017
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Descriptors Indwelling devices|Polymers|Test methods|Ureteral stents|Urology
ICS11.040.40
PublisherASTM
FormatA4
DeliveryYes
Pages8
File Size196 KB
Price£40.00


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