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输尿管展伸的标准规范  
 【英文标准名称】  Standard Specification for Ureteral Stents
 【原文标准名称】  输尿管展伸的标准规范
 【标准号】  ASTM F1828-1997(2006)
 【标准状态】  Active
 【国别】  
 【发布日期】  1997
 【实施或试行日期】  
 【发布单位】  美国材料与试验协会(US-ASTM)
 【起草单位】  F04.34
 【标准类型】  (Specification)
 【标准水平】  ()
 【中文主题词】  内在装置;输尿管展伸;高聚物;试验方法;泌尿科学
 【英文主题词】  indwelling devices; polymers; test methods; ureteral stents; urology
 【摘要】  

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 ExclusionsLong-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 , of this specification:

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.

 【中国标准分类号】  C18
 【国际标准分类号】  11_040_40
 【页数】  6P.;A4
 【正文语种】  
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