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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.
Standard Specification for Ureteral Stents
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.
Standard Specification for Ureteral Stents
Elastomeric parts for aqueous parenteral preparations; Amendment 1
Defines 7 terms used in the field of urine absorbing aids and comprises the vocabulary for conditions of urinary incontinence. The terms used for conditions of urinary incontinence do not suggest a particular diagnosis and conform to the terminology recommended by the International Continence Society Committee.
Urine absorbing aids; vocabulary; part 1: conditions of urinary incontinence
Defines 9 terms used in the field of urine absorbing aids and comprises the vocabulary for products. The terms used for products do not, individually or collectively, define or recommend specific designs, styles or constructions.
Urine absorbing aids; vocabulary; part 2: products
The system of identification established is based on classification and coding. The classification system is a subclassification of ISO 9999:1992, Technical aids for disabled persons - Classification.
Urine absorbing aids; vocabulary; part 3: identification of product types
Prezentul standard stabile?te dimensiunile ra?pelelor pentru cizm?rie.
Shoe rasps dimensions
Prezentul standaid stabile?te dimensiunile ?a?pelelor utilizate pentiu prelucrarea lemnului.
Woodworking rasps dimensions
Prezentul standard stabile?te condi?iile tehnice generale de calitate pentru ra?pelele folosite ?n lucr?ri de cizm?rie, potcov?rie, prelucrarea lemnului etc.
Rasps. General technical requirements for quality
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